Hi Everyone, I hope spring has sprung or is actively springing where you are. The cherry blossoms have been hiding, waiting for a warm sun to open them up.

It's time for an update. We hope you click through to the details.

Link to the details of this update, including:

•   High-Throughput Truthing (HTT) Project Update
  • Pitch: We are launching a project to crowdsource pathologists and collect data (images + pathologist annotations) that can be qualified by the FDA/CDRH medical device development tool program (MDDT). The MDDT qualified data would be available to any algorithm developer to be used to validate their algorithm performance in a submission to the FDA/CDRH.
•   HTT Project Call for Collaboration
•   Quick info about FDA submissions for medical imaging algorithms
   

Link to full list of HTT updates

Link to full list of eeDAP updates

Cheers,

The WSI WG team

355

2:39 pm

08 Apr 2019

WebEx Reminder: “Evaluating Computational Pathology at the US FDA and Related Research”

Thursday at 11am EST on 11 October 2018

Here’s a link to descriptive information about the content of the Webex.

Join Webex meeting

• Meeting number (access code): 985 222 294
• Meeting password: Nq4G5CQV

• Join by phone

• +1-210-795-0506 US Toll
• +1-877-465-7975 US Toll Free
• Global call-in numbers
• Toll-free calling restrictions

Can’t join the meeting?

If you are a host, go here to view host information.

IMPORTANT NOTICE: Please note that this Webex service allows audio and other information sent during the session to be recorded, which may be discoverable in a legal matter. By joining this session, you automatically consent to such recordings. If you do not consent to being recorded, discuss your concerns with the host or do not join the session.

332

10:01 am

11 Oct 2018

Summer is over, the new fiscal year is started (for the US gov), and we are planning our next year of research in FDA’s Office of Science and Engineering Laboratories, and hopefully in collaboration with members of the WSI WG community. A reminder here is that OSEL is the research arm of CDRH and does not necessarily reflect any specific policy/decision making of CDRH’s regulatory offices (OIR or ODE).

 * Brandon Gallas will give a '''!WebEx reprise of his presentation''' given at the European Congress of Pathology on 9 September 2018
    * “Evaluating Computational Pathology at the US FDA and Related Research.” (Link to presentation.)
    * !WebEx Date and Time: '''Thursday at 11am on 11 October 2018''' (Link to WebEx info.)

 * In addition to the ECP presentation, I plan to summarize my research plans for the coming year.  Primarily, I plan to collect data (images and annotations) and propose it to be qualified by the FDA/CDRH as a Medical Device Development Tool (MDDT) to be used in submissions to the FDA to validate algorithms.  I will also outline other WSI- and algorithm-related projects by other investigators in my division:
    * Marios Gavrielides plans to examine issues related to the stand-alone assessment of computer-aided diagnosis systems for primary diagnosis, with an application to ovarian cancer subtyping.
    * Anant Agrawal plans to develop a phantom for technical assessment of WSI systems using nanoscale 3D printing.
    * Berkman Sahiner and Weijie Chen plan to expand the evaluation of artificial intelligence and machine learning devices to less structured post-market reference standards and higher risk/higher impact autonomous use.

 * Brandon Gallas is conducting a '''pilot reader study''' at the Annual Meeting of the American Society of Clinical Pathologists in '''Baltimore on 3-5 October 2018.'''
    * This pilot is to support the data MDDT project mentioned above.
    * The pathologists’ tasks are to evaluate lymphocytes in lung tumors.
    * Come find the booth, hear about the study, and participate!
    * We hope to follow up the pilot with a pivotal study at the San Antonio Breast Cancer Symposium or other venue with many pathologists. If you are a conference organizer or are leadership in a professional society and want to help make this happen, please contact Brandon.

 * Check out, “Advancing Regulatory Science with Computational Modeling for Medical Devices at the FDA’s Office of Science and Engineering Laboratories” (Link to paper.). You will be surprised by what is happening at the FDA.

 * Enough of Brandon and FDA-related research, it’s time to hear from the WSI WG. What are you doing? What are your concerns? What discussions and collaborations should we be having? Several WSI WG members have asked what happened to the discussions about using phantoms for the technical performance assessment of WSI scanners, especially as image quality impacts training and testing in computational pathology.
    * '''How should we leverage and engage the 145 WSI WG members?'''
    * Please send co-committee member Marios Gavrielides ideas (Marios.Gavrielides@fda.hhs.gov). He will summarize the feedback that he receives and plan future discussions.

327

2:40 pm

02 Oct 2018

Hello everyone, Let me apologize for the accidental announcement earlier. It was very old.

I’m contacting you now to let you know about a presentation, '' “A reader study on a 14-head microscope,” '' to be given at Pathology Informatics at 8:15am on Wednesday 5/23/2018. This work is feeding an FDA project titled, '' “High-throughput truthing of microscope slides to validate artificial intelligence algorithms analyzing digital scans of pathology slides: leveraging data collected in international "grand challenges”. '' Since writing the proposal, we have settled on a specific deliverable that many groups are excited about: collaborating with challenge organizers and other organizations to produce images + annotations to be qualified by FDA as medical device development tools (MDDTs). As MDDTs, the images + annotations can then be used by algorithm developers to test the performance of AI algorithms in an FDA submission with very little description and validation, easing the the regulatory burden for industry and the FDA.

• Presentation abstract and slides at https://nciphub.org/groups/eedapstudies/wiki/Presentation:AReaderStudyona14headMicroscope
• Project description: https://nciphub.org/groups/eedapstudies/wiki/HighThroughputTruthing
• FDA medical device development tools (MDDTs): https://www.fda.gov/MedicalDevices/ScienceandResearch/MedicalDeviceDevelopmentToolsMDDT

This announcement is archived in the blog: https://nciphub.org/groups/wsi_working_group/blog/2018/05/truthing-microscope-slides-to-validate-artificial-intelligence-algorithms

316

9:50 am

21 May 2018

Happy New Year. This is a quick email to update you on things for the new year.

New project: High-throughput truthing of microscope slides to validate artificial intelligence algorithms analyzing digital scans of pathology slides: leveraging data collected in international “grand challenges”.
Contact Brandon Gallas if you are interested in participating or receiving updates as this project gets started.

Staff position available at the FDA to support the project above. Please check out and share the job description at https://tinyurl.com/y7qbkdqw .

Webinars: Here are a couple ideas that we are considering.

• 1pm-2pm EST on Feb. 7, 2018: Tentative webinar (hosted by DPA) on interoperability and component testing in whole-slide-imaging systems. An encore presentation with updates of what was presented at Pathology Visions by Esther Abels (Philips) and Aldo Badano OSEL/CDRH/FDA.
• “Strategies for Accelerating Quantitative Imaging Regulatory Approval at the FDA,” Kyle Myers, Director of the Division of Imaging, Diagnostics, and Software Reliability, OSEL/CDRH/FDA.
• “In silico imaging clinical trials for regulatory evaluation: initial considerations for VICTRE, a demonstration study,” Aldo Badano, Dep. Director of the Division of Imaging, Diagnostics, and Software Reliability, OSEL/CDRH/FDA.

Please contact Marios Gavrielides to let us know if these webinars are interesting to you and if there are other webinars that you would like to see or present.

299

10:32 am

10 Jan 2018

Hi all, in case you missed it but interested, here is the link below to the recording of the webinar on color calibration.  (I apologize for starting the recording a minute or so late.)

Brief, over-simplified highlights:

• In the first talk, Craig Revie from FFEI outlined the process to develop the Sierra Calibration slide, which includes colors extracted from common stains in pathology practice
• In the second talk, Dr. Emily Clarke from Leeds University described a study where the Sierra calibration slide was used to produce more consistent/comparable color profiles from different WSI scanners, and a follow up reader study assessed the effect on pathologist preference.

Let me know of any comments or questions I could pass to the presenters.

Best regards,

Marios

Marios A Gavrielides, Ph.D.

Staff Scientist/Biomedical Engineer
Division of Imaging, Diagnostics, and Software Reliability
Office of Science and Engineering Laboratories
Center for Devices and Radiological Health
Food and Drug Administration
Tel: (301) 796-2545

marios.gavrielides@fda.hhs.gov

Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received:   https://www.research.net/s/cdrhcustomerservice?O=700&D=750&B=750&E=&S=E

From: messenger@webex.com [mailto:messenger@webex.com]
Sent: Wednesday, December 13, 2017 10:54 AM
To: Gavrielides, Marios A
Subject: Your recording "WSI WG Webinar on Color Calibration-20171213 1508-1" is available for viewing

Marios Gavrielides,

Your recording is now available on the WebEx service site. Click the link below to play it:

https://fda.webex.com/fda/lsr.php?RCID=b8839c23be8c448f9e9c5303454049c7

WSI WG Webinar on Color Calibration-20171213 1508-1
Wednesday, December 13, 2017 10:08 am New York Time
44 min 31 sec

* You can forward this message to others to allow them to play back the recording. *

-------------------------------------
Additional Options
-------------------------------------

To edit recording information and playback control options, click the link below:
https://fda.webex.com/fda/editrd.php?RCID=6d5af165b18d4adf93f0b2d6e3b50e5b

To view more options for this recording, such as downloading, click the link below:
https://fda.webex.com/fda/viewrd.php?RCID=0b4d669865d24721afeb261b9bef9629

To view all your WebEx Meeting Center recordings, click the link below:
https://fda.webex.com/fda/servicerds.php?SP=MC

FDA Rich Media at 301-796-3333.

297

12:46 pm

19 Dec 2017

Hi all, just a gentle reminder about Wednesday's webinar on color calibration.  Please see details below. 

Best regards,

Marios Gavrielides

Dear all, I would like to announce our next Whole Slide Image Working Group webinar which will be held on Dec 13, 2017, between 10-11am EST and will focus on Color Calibration for whole slide imaging systems.

The webinar will include the following two presentations:

• Sierra Calibration Slide,  by W Craig Revie, Ph.D., FFEI Limited
• Colour Calibration in Digital Pathology: The Clinical Impact of a Novel Color Calibration Slide, by Emily Clarke, M.D., Univ of Leeds/Leeds Teaching Hospital

 The Abstracts for the presentations as well as WebEx connection information are shown below. 

Looking forward to your attendance for this webinar,

Marios A Gavrielides, Ph.D., OSEL/CDRH/FDA

WSI WG Organizing Committee

1. Sierra calibration slide

W Craig Revie, FFEI Limited

Abstract

In digital microscopes and whole slide imaging systems, images of slides are captured, transmitted and reproduced on a computer display. In order to allow pathologists to interpret these images accurately and efficiently it is important that colours from the slides are displayed in a consistent and reliable fashion.

The final colour of the image presented to the viewing pathologist depends on several steps through the imaging pathway, including sample illumination, magnification, image capture, compression, storage, and reproduction on the computer display. There are many possible system designs and, within a single system, different setup options which can affect the final image leading to significant variation in image appearances.

This paper will discuss the challenges encountered in the development of a suitable colour target that includes a set of patches with spectra similar to those encountered when viewing pathology slides with stained tissue samples. This is known as the Sierra slide and is expected to be available commercially in the first half of 2018.

2. Colour Calibration in Digital Pathology: The Clinical Impact of a Novel Color Calibration Slide

Emily Clarke, M.D.,  Univ of Leeds/Leeds Teaching Hospital

Abstract

Considerable color variation of whole slide images (WSIs) is introduced through the scanning process. We created a novel color calibration slide which utilizes real histopathological stains and a tissue-like substrate to minimize the effect of color variation of WSIs due to the digital slide scanner. We aimed to evaluate its clinical application. Objectives included: 1. Whether calibration made WSIs appear closer in color to the glass slide counterpart, 2. Whether pathologists prefer calibrated WSIs and, 3. Whether calibration affected diagnostic confidence.

Six tissue WSIs were generated and calibrated using a color profile created with the color calibration slide. Twelve pathologists, blinded to intervention, compared calibrated and uncalibrated WSIs on a color calibrated medical grade display and recorded their results on a 7-point Likert scale. 

Calibrated WSIs were closer in appearance to the microscope in 40 of 72 trials, (56%) and were preferred in 46 of 72 trials (64%). The recorded diagnostic confidence was higher for color calibrated slides; none of the pathologists recorded that color calibration reduced their diagnostic confidence.

This study suggests that color calibrated WSIs using the novel color calibration slide may be preferable to pathologists and may also beneficially increase diagnostic confidence. Further research will investigate the impact of color calibration on diagnosis.

Web-Ex connection info:

Marios Gavrielides invites you to attend this online meeting.

Topic: WSI WG Webinar on Color Calibration
Date: Wednesday, December 13, 2017
Time: 10:00 am, Eastern Standard Time (New York, GMT-05:00)
Meeting Number: 742 999 427
Meeting Password: 1234


-------------------------------------------------------
To join the online meeting
-------------------------------------------------------
1. Go to https://fda.webex.com/fda/j.php?MTID=m5483982f15ee8421e23ff6c6d7571e47
2. If requested, enter your name and email address.
3. If a password is required, enter the meeting password: 1234
4. Click "Join".

To view in other time zones or languages, please click the link:
https://fda.webex.com/fda/j.php?MTID=m49b39badf3e398c8cb4f3dff30f5bf75

-------------------------------------------------------
To join the teleconference only
-------------------------------------------------------
1. Provide your number when you join the meeting to receive a call back. Alternatively, you can call one of the following numbers:
Local: 1-301-796-7777
toll free: 1-855-828-1770
2. Follow the instructions that you hear on the phone.
Your Cisco Unified MeetingPlace meeting ID: 742 999 427

-------------------------------------------------------
For assistance
-------------------------------------------------------
1. Go to https://fda.webex.com/fda/mc
2. On the left navigation bar, click "Support".

You can contact me at:
marios.gavrielides@fda.hhs.gov
1-301-796-2545

Add this meeting to your calendar (Cannot add from mobile devices):
https://fda.webex.com/fda/j.php?MTID=m4076e19761e9c6e2f4f9bc729164ab61



FDARichMedia@fda.hhs.gov



IMPORTANT NOTICE: This WebEx service includes a feature that allows audio and any documents and other materials exchanged or viewed during the session to be recorded. By joining this session, you automatically consent to such recordings. If you do not consent to the recording, discuss your concerns with the meeting host prior to the start of the recording or do not join the session. Please note that any such recordings may be subject to discovery in the event of litigation.

296

9:22 am

11 Dec 2017

Greetings everyone,

It’s been a while since we last talked and I’d like to update you about what has been happening with the eeDAP studies MDDT (project description). Details about the following list are at this link (https://nciphub.org/groups/eedapstudies/wiki/20171121update). Please go check out the details, especially the first item which is about a new project getting off the ground.

• New project: High-throughput truthing of microscope slides to validate artificial intelligence algorithms analyzing digital scans of pathology slides: leveraging data collected in international “grand challenges”.
• FDA Commissioner Scott Gottlieb visited Brandon Gallas' lab (see pics below).
• Revised “Context of Use” and strategy for eeDAP MDDT.
• Registration accuracy studies.
• Material transfer agreement (MTA) to loan an eeDAP system to Memorial Sloan Kettering Cancer Center (MSKCC).
• MSKCC reader study on a 14-head microscope!
• FDA visited Cold Spring Harbor Laboratory to help them install their own eeDAP system.

You are welcome to join the eeDAP studies group and participate or observe. It is open to the public, so you can always browse to the group see the updates that are posted. Contact Brandon.Gallas@fda.hhs.gov if you have any questions.

295

3:02 pm

04 Dec 2017

Whole Slide Image Working Group webinar series: focus on color calibration

Dear all, I would like to announce our next Whole Slide Image Working Group webinar which will be held on Dec 13, 2017, between 10-11am EST and will focus on Color Calibration for whole slide imaging systems.

The webinar will include the following two presentations:

• Sierra Calibration Slide,  by W Craig Revie, Ph.D., FFEI Limited
• Colour Calibration in Digital Pathology: The Clinical Impact of a Novel Color Calibration Slide, by Emily Clarke, M.D., Univ of Leeds/Leeds Teaching Hospital

 The Abstracts for the presentations as well as WebEx connection information are shown below. 

Looking forward to your attendance for this webinar,

Marios A Gavrielides, Ph.D., OSEL/CDRH/FDA

WSI WG Organizing Committee

1. Sierra calibration slide

W Craig Revie, FFEI Limited

Abstract

In digital microscopes and whole slide imaging systems, images of slides are captured, transmitted and reproduced on a computer display. In order to allow pathologists to interpret these images accurately and efficiently it is important that colours from the slides are displayed in a consistent and reliable fashion.

The final colour of the image presented to the viewing pathologist depends on several steps through the imaging pathway, including sample illumination, magnification, image capture, compression, storage, and reproduction on the computer display. There are many possible system designs and, within a single system, different setup options which can affect the final image leading to significant variation in image appearances.

This paper will discuss the challenges encountered in the development of a suitable colour target that includes a set of patches with spectra similar to those encountered when viewing pathology slides with stained tissue samples. This is known as the Sierra slide and is expected to be available commercially in the first half of 2018.

2. Colour Calibration in Digital Pathology: The Clinical Impact of a Novel Color Calibration Slide

Emily Clarke, M.D.,  Univ of Leeds/Leeds Teaching Hospital

Abstract

Considerable color variation of whole slide images (WSIs) is introduced through the scanning process. We created a novel color calibration slide which utilizes real histopathological stains and a tissue-like substrate to minimize the effect of color variation of WSIs due to the digital slide scanner. We aimed to evaluate its clinical application. Objectives included: 1. Whether calibration made WSIs appear closer in color to the glass slide counterpart, 2. Whether pathologists prefer calibrated WSIs and, 3. Whether calibration affected diagnostic confidence.

Six tissue WSIs were generated and calibrated using a color profile created with the color calibration slide. Twelve pathologists, blinded to intervention, compared calibrated and uncalibrated WSIs on a color calibrated medical grade display and recorded their results on a 7-point Likert scale. 

Calibrated WSIs were closer in appearance to the microscope in 40 of 72 trials, (56%) and were preferred in 46 of 72 trials (64%). The recorded diagnostic confidence was higher for color calibrated slides; none of the pathologists recorded that color calibration reduced their diagnostic confidence.

This study suggests that color calibrated WSIs using the novel color calibration slide may be preferable to pathologists and may also beneficially increase diagnostic confidence. Further research will investigate the impact of color calibration on diagnosis.

Web-Ex connection info:

Marios Gavrielides invites you to attend this online meeting.

Topic: WSI WG Webinar on Color Calibration
Date: Wednesday, December 13, 2017
Time: 10:00 am, Eastern Standard Time (New York, GMT-05:00)
Meeting Number: 742 999 427
Meeting Password: 1234


-------------------------------------------------------
To join the online meeting
-------------------------------------------------------
1. Go to https://fda.webex.com/fda/j.php?MTID=m5483982f15ee8421e23ff6c6d7571e47
2. If requested, enter your name and email address.
3. If a password is required, enter the meeting password: 1234
4. Click "Join".

To view in other time zones or languages, please click the link:
https://fda.webex.com/fda/j.php?MTID=m49b39badf3e398c8cb4f3dff30f5bf75

-------------------------------------------------------
To join the teleconference only
-------------------------------------------------------
1. Provide your number when you join the meeting to receive a call back. Alternatively, you can call one of the following numbers:
Local: 1-301-796-7777
toll free: 1-855-828-1770
2. Follow the instructions that you hear on the phone.
Your Cisco Unified MeetingPlace meeting ID: 742 999 427

-------------------------------------------------------
For assistance
-------------------------------------------------------
1. Go to https://fda.webex.com/fda/mc
2. On the left navigation bar, click "Support".

You can contact me at:
marios.gavrielides@fda.hhs.gov
1-301-796-2545

Add this meeting to your calendar (Cannot add from mobile devices):
https://fda.webex.com/fda/j.php?MTID=m4076e19761e9c6e2f4f9bc729164ab61



FDARichMedia@fda.hhs.gov



IMPORTANT NOTICE: This WebEx service includes a feature that allows audio and any documents and other materials exchanged or viewed during the session to be recorded. By joining this session, you automatically consent to such recordings. If you do not consent to the recording, discuss your concerns with the meeting host prior to the start of the recording or do not join the session. Please note that any such recordings may be subject to discovery in the event of litigation.

291

10:28 am

28 Nov 2017

Upcoming webinar on color calibration issues

• Dec. 13, at 10am EST
• Speakers: Emily Clarke and Craig Revie
• This blog item will be updated with talk titles, abstracts, and webinar information

[slides added] DPA and FDA Presenting at Pathology Visions Regulatory Update: Interoperability

• Presenters: Esther Abels (Philips and DPA) and Aldo Badano (FDA)
• We have updated the blog item description of the event with links to the slides presented.

Thank you, WSI WG

290

9:30 am

22 Nov 2017

We have a message for everyone interested in computational pathology.
The FDA Pre-certification program could significantly impact regulation of computational pathology.

Here is a link to information about a webinar, "FDA PreCertification (Pre-Cert) Pilot Update."
November 17, 2017
Time: 1:30 p.m., Eastern Time.

Here is a link to the FDA home page for the program. At this home page, you can find an email for questions and submit feedback to the program staff.

289

9:47 am

16 Nov 2017

Hi all, this is just a gentle reminder about Monday's webinar.  Details below.  I hope you can attend.

Best regards,

Marios

Title:      Quantifying image quality of Whole Slide Imaging (WSI) scanners

Abstract:  The quality of an image produced by the Whole Slide Imaging (WSI) scanners is of critical importance for using the image in clinical diagnosis. Therefore, it is very important to monitor and ensure the quality of images. Since subjective image quality assessments by pathologists are very time-consuming, expensive and difficult to reproduce, we propose a method for objective assessment based on clinically relevant and perceptual image parameters: sharpness, contrast, brightness, uniform illumination and color separation; derived from a survey of pathologists. We developed techniques to quantify the parameters based on content-dependent absolute pixel performance and to manipulate the parameters in a predefined range resulting in images with content-independent relative quality measures. The method does not require a prior reference model. A subjective assessment of the image quality is performed involving 69 pathologists and 372 images (including 12 optimal quality images and their distorted versions per parameter at 6 different levels). The results of the subjective assessment support the validity of the proposed objective image quality assessment method to model the readers' perception of image quality. The subjective assessment also provides thresholds for determining the acceptable level of objective quality per parameter. The images for both the subjective and objective quality assessment are based on the HercepTest slides scanned by the Philips Ultra Fast Scanners, developed at Philips Digital Pathology Solutions. However, the method is applicable also to other types of slide stains and scanners. The method was successfully applied to evaluate WSI scanner reproducibility.

WSI WG webinar by Philips: Quantifying image quality of WSI scanners

Monday, October 16, 2017

10:00 am  |  Eastern Daylight Time (New York, GMT-04:00)  |  1 hr

Meeting number: 748 117 909

Meeting password: 1234

Add to Calendar

When it's time, join the meeting.

Join by phone

Local: 1-301-796-7777

toll free: 1-855-828-1770

Your Cisco Unified MeetingPlace meeting ID: 748 117 909

Can't join the meeting?

IMPORTANT NOTICE: Please note that this WebEx service allows audio and other information sent during the session to be recorded, which may be discoverable in a legal matter. By joining this session, you automatically consent to such recordings. If you do not consent to being recorded, discuss your concerns with the host or do not join the session.

286

3:15 pm

12 Oct 2017

Subject: DPA and FDA Presenting at Pathology Visions Regulatory Update: Interoperability

Greetings. I am writing to share news that the Pathology Visions Regulatory Update session will include presentations from the FDA and DPA, followed by a panel discussion. The main topic will be interoperability in the digital pathology imaging and viewing pipeline, with an emphasis on displays.

Tuesday, October 3, 2017 from 4:30 – 5:30 PM
Manchester Grand Hyatt 
San Diego, CA

• Aldo Badano (Speaker + panelist)
  • FDA/CDRH/OSEL Division of Imaging, Diagnostics, and Software reliability
• Esther Abels (Speaker + panelist)
  • DPA Regulatory & Standards Task Force Chair
  • Philips Digital Pathology
• Dr. Eric Glassy (Panelist)
  • DPA president
  • Affiliated Pathologists Medical Group (APMG)

We are soliciting questions or comments that can be addressed in the presentations by Aldo or Esther, or in the panel discussion. Please add a comment to this blog item, anonymously if you wish. We hope you understand that we cannot guarantee that we can address any or all comments or questions, but we definitely want them on our radar for the future. Also, this session is not a replacement for a (formal) pre-submission regulatory discussion; this is about principles and pathways.

All the best,
Brandon

281

10:17 am

23 Aug 2017

Subject: Summer Announcements

We hope you are enjoying your summer and wanted to make a few announcements.

The FDA scientists are exploring an opportunity to discuss interoperability in components of whole-slide imaging systems in the regulatory update at Pathology Visions. We'll confirm our participation once the plan is set.

There is a new Medical Devices->Digital Health program being piloted at the FDA as a result of the 21st Century Cures Act that you might be interested in: Digital Health Software Precertification (PreCert) Program. The Software PreCert Pilot Program is a voluntary program being piloted that will enable us to develop a tailored approach toward regulating this technology by looking first at the software developer and/or digital health technology developer, rather than primarily at the product, which is what we currently do for more traditional medical devices. CDRH will hold a webinar at 1:00-2:30 on August 1, 2017 to provide additional information on this program and to answer stakeholder questions.

The slides that were presented at the WSI WG face-to-face meeting 5/21/17 at Pathology Informatics can be found at WSI_WG_project->files folder. This includes links to a rough recording of the meeting and Brandon Gallas' presentation during the regular PI track.

The FDA scientists are working on the technical performance evaluation of eeDAP for the Medical Device Development Tool (MDDT) application. This includes the evaluation of slide/image registration accuracy and color reproduction in eeDAP (Matlab) versus a proprietary viewer. The FDA scientists are also designing and conducting eeDAP studies with other teams. Check out the wiki for that project-oriented subgroup of the WSI WG.

All the best, Brandon.

All announcements are saved as blog items (LINK)

275

4:24 pm

31 Jul 2017

Subject: Agenda and WebEx for Face-to-Face Meeting at Pathology Informatics, 1:30-5pm, Sunday, May 21, 2017

We have an exciting agenda for this years meeting at Pathology Informatics, see below. We hope you are planning to attend.
If you can't make it, but don't want to completely miss out, you can attend by WebEx (LINK TO WEBEX INFO).
To prepare for the meeting, you may want to check out some recent posts

• eeDAP proposal accepted for the incubator phase of the Medical Device Development Tool program

• Slides about the MDDT program at FDA's Center for Devices and Radiological Health

• "FDA's role in the innovation and evaluation of evolving computer-aided diagnosis (CAD) solutions"

See you in Pittsburgh!

----------------------------------------------------------------------------------------------------------------

4th WSI Working Group OPEN MEETING

Feature studies comparing digital and microscope viewing modes:
a WSI working group project @ Pathology Informatics Summit 2017

1:30-5:00PM, May 21, 2017, Wyndham Grand Pittsburgh Downtown, King’s Garden 3

• 1:30 PM (15 min, 15 min)
  • Welcome, Meeting Overview, eeDAP Demo
    Brandon D. Gallas, PhD
    FDA/CDRH/OSEL/Division of Imaging, Diagnostics, Software Reliability
• 1:45 PM (15 min, 30 min)
  • Overview of FDA’s Medical Device Development Tool (MDDT) program
    Marios A. Gavrielides, PhD
    FDA/CDRH/OSEL/Division of Imaging, Diagnostics, Software Reliability
• 2:00 PM (20 min, 50 min)
  • eeDAP Registration Accuracy Evaluation
    Qi Gong, MS
    FDA/CDRH/OSEL/Division of Imaging, Diagnostics, Software Reliability
• 2:20 PM (40 min, 90 min)
  • Summary of Philips 510k Technical Performance Methods and Results
    Prarthana Shrestha,  PhD
    Philips, Department of Healthcare Applications
• 3:00 PM (20 min, 110 min)
  • Development of a novel quality assessment tool for digital microscopy
    Emily L. Clarke, MD
    University of Leeds and Leeds Teaching Hospitals NHS Trust, Leeds, UK
• 3:20 PM (20 min, 130 min)
  • Break, hands-on demos with eeDAP
• 3:40 PM, (15 minutes, 145 min)
  • Image Quality Tool
    Prarthana Shrestha,  PhD
    Philips, Department of Healthcare Applications
• 3:55 PM, (45 minutes, 190 min)
  • Mitotic counting studies: Results using a clinical-protocol and plans for eeDAP version
    Stephen M. Hewitt, MD, PhD
    Laboratory of Pathology, CCR, NCI, NIH
    Brandon D. Gallas, PhD
    Division of Imaging, Diagnostics, and Software Reliability, OSEL, CDRH, FDA
• 4:40 PM (20 min, 210 min)
  • Closing discussion
  • MDDT next steps. Meeting with FDA. Bring questions. We want to change “Context of Use”. No reader study data. Technical assessment only.
  • Install eeDAP at MSKCC June 20-21. Other installations, pilot studies, etc?
  • Face-to-face meetings.

256

10:00 am

16 May 2017

REMINDER: Please check out our request for proposals to present at our face-to-face meeting the Sunday before the Pathology Informatics Summit (Sunday May 21, 1:30-5pm). We are finalizing our agenda and want you to be involved. Here is the LINK to the call for proposals. Contact Marios.Gavrielides@fda.hhs.gov

We hope you are planning to attend the face-to-face meeting to kick off the Pathology Informatics Summit. It should be pretty interesting. The main topic will be an update about the project to provide evidence to support the eeDAP Medical Device Development Tool submission. Read more about the submission HERE and the actual project activities HERE.

Have a great week!
Brandon

253

1:14 pm

08 May 2017

Dear all, as you know we are getting closer to the Pathology Informatics conference and our 4^th WSI workshop which gets the conference started.  A big component of the workshop this year will be updates related to eeDAP and its qualification as a Medical Device Development Tool (MDDT).  As you may recall from his announcements to this group (LINK), Brandon has been working with a few groups (WSIWG members), to conduct eeDAP studies where pathologists can review fields of view co-registered between the microscope and digital view. The studies will provide evidence to support the MDDT qualification of eeDAP. Additionally, the collaboration is developing methods to assess the technical performance of eeDAP in terms of accuracy and precision of the eeDAP co-registration process and color reproduction. 

In addition to updates on the eeDAP MDDT qualification,, we would like to ask the WSIWG members if they are interested in presenting any work that relates to WSI evaluation and would be relevant to this group.  Topics may include, and are not limited to, the following:

·         updates on the development of phantoms for the assessment of WSI technical properties such as focus, resolution or color

·         updates or completed work on WSI-related evaluation projects

·         shared resources (data, software) related to WSI evaluation

·         proposals for collaborative projects between members of this group on WSI-related research

A format that worked very well previously included presentations followed by reviewers for each presentation that were preselected to provide feedback or expand on those presentations.  This year we would like to do something similar. 

So, please let me know, preferably by May 8, if you are interested: a) to present to the group, or b) to review/expand on a presentation.  The committee will select presentations, match presenters/reviewers, and finalize the agenda of the workshop by May 12, so it can be posted early on the conference website.

We will definitely appreciate your effort in making this an informative workshop that can form the basis for future collaborations and exchange of ideas related to WSI evaluation.

Thanks in advance,

Marios Gavrielides (on behalf of the WSI WG organizing committee

251

9:47 am

27 Apr 2017

You may already know …

FDA allows marketing of first whole slide imaging system for digital pathology

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm552742.htm

You may also already know …

The WSI working group will be meeting again Sunday May 21, the afternoon before the Pathology Informatics Summit.

Please make arrangements to attend this public meeting. We will be discussing the WSI WG project investigating feature/reproducibility studies to support the proposed Medical Device Development Tool (LINK). More information coming.

249

1:31 pm

13 Apr 2017

RE: Time to submit proposal: FDA/CDRH Medical Device Development Tool for digital pathology

This announcement is an update of our efforts to qualify eeDAP as a Medical Device Development Tool. If you are unfamiliar with this project, eeDAP, or the Medical Device Development Tool program, please refer to earlier blog items:
21 October 2017: FDA/CDRH Medical Device Development Tool
09 January 2017: Draft Proposal of FDA/CDRH Medical Device Development Tool

I have received comments from a couple WSI WG members and from FDA/CDRH staff, and I have updated the proposal accordingly.
Updated Proposal: MDDTproposal-2.pdf
Review Comments

I will submit this proposal COB Wednesday, giving a day for you to review. If you have comments, send them directly to me.

Next steps: I have contacted several groups that have expressed interest in running an eeDAP study at their institution, and I am having one-off meetings with them to discuss their goals and plans. Once we finish with basic introductions, we will start planning 1-3 eeDAP studies together. If you are interested in joining this team, contact me.

Thank you,

Brandon D. Gallas
Mathematician     
Center For Devices and Regulatory Health
Office of Science and Engineering Laboratories
U.S. Food and Drug Administration
Tel: 301-796-2531
Brandon.Gallas@fda.hhs.gov

Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received: https://www.research.net/s/cdrhcustomerservice?O=700&D=770&B=770&E=&S=E

239

5:08 pm

23 Jan 2017

Subject: Draft Proposal of FDA/CDRH Medical Device Development Tool (go to this blog item)

Happy New Year everyone.

A little over two months ago we announced a project to pursue FDA/CDRH Medical Device Development Tool (MDDT) qualification of eeDAP, an evaluation environment for digital and analog pathology, and we intend to document the process with the WSI WG. Please refer to that blog entry for details on the MDDT program and eeDAP (LINK). First and foremost, we believe that eeDAP will be useful to the regulatory evaluation of WSI scanners. Next, we believe that the MDDT qualification process is similar to the FDA/CDRH medical device submission process; both need documentation and supporting evidence for their use ... so sharing this process provides a window into the business and culture of the FDA. Finally, we believe that there are other candidate MDDTs in the WSI WG community that could aid in regulatory evaluation of WSI scanners ... so we hope that sharing this process will inspire other MDDT submissions (e.g., phantom slides).

Today we are sharing our draft proposal (LINK). Please check it out. We welcome comments and questions. Send them directly to Brandon Gallas (Link to Profile).
We will submit this proposal at the end of the week (13 Jan. 2017) unless we need more time for revisions based on your comments and questions.

Coming soon: We will need help when our proposal is accepted for a full submission. Most importantly, we will need help collecting the evidence that eeDAP can collect task-based evaluations of tissue features and cell features digitally and on the microscope. We are putting together a collaborative team to conduct 1-3 eeDAP studies to demonstrate its advantages over typical clinical evaluation protocols. The advantage of using eeDAP compared to typical clinical evaluation protocols is that eeDAP studies are fast and customizable, use fewer resources, and yield performance results that are more precise and reproducible. Please contact Brandon Gallas (Link to Profile) to be added to the team.

Brandon D. Gallas
Mathematician     
Center For Devices and Regulatory Health
Office of Science and Engineering Laboratories
U.S. Food and Drug Administration
Tel: 301-796-2531
Brandon.Gallas@fda.hhs.gov

Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received: https://www.research.net/s/cdrhcustomerservice?O=700&D=770&B=770&E=&S=E

All messages are saved as blog items (LINK)

236

3:50 pm

09 Jan 2017