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For those of you that missed Nick Anderson’s presentation at Pathology Visions in October titled, “Regulatory Challenges and Opportunities for Digital Pathology,” you can find the slides on the WSI WG site in the resources section.

https://nciphub.org/resources/1927

Feel free to upload papers and presentations (or links or blog items) that are related to our focus: evaluation of technical and pathology performance and then ask the group organizers to announce your post.

Abstract:
FDA has cleared or approved a number of digital pathology devices for different intended uses, such as digital read and image analysis of immunohistochemically stained tissue slides, classification and enumeration of peripheral blood cells, and initial screening of cervical cytology slides.  FDA has been actively engaged in discussions with various stakeholders regarding whole slide imaging systems intended for primary diagnosis of H&E stained slides. To ensure that the images produced from H&E stained slides are safe and effective for use as an aid in primary diagnosis of cancer, FDA has maintained that WSI manufacturers should assess technical performance of the components in the imaging chain, and demonstrate analytical and clinical performance using a sufficient number of specimens and readers representative of the intended use populations.  FDA has provided WSI manufacturers with outlines of various validation studies and performance measures. This presentation is intended to provide an overview of regulatory challenges and opportunities for WSI.

Biography:
Dr. Anderson is a scientific reviewer in FDA’s Office of In Vitro Diagnostics and Radiological Health. He earned his B.S. in Mathematics and his M.S. and Ph.D. in Industrial Engineering with focus on simulation, optimization, and algorithm development. He has over 20 years engineering experience in areas ranging from heavy manufacturing to logistics to missile defense. He joined the Office of In Vitro Diagnostics and Radiological Health in 2010 where he provides scientific review of pre-submissions, 510(k)s and PMAs submitted to the Division of Molecular Genetics and Pathology. He specializes in the review of hardware and software, assessing safety and effectiveness. 

 

Hello all,

 

It has been a quiet summer for the WSI WG. We tried to get space at Pathology Visions, but we were unsuccessful. So what next?

 

My management has asked that I submit the tool eeDAP to the FDA/CDRH MDDT program (Medical Device Development Tool).

eeDAP stands for evaluation environment for digital and analog pathology, and I discussed it during my talk at Pathology Informatics last May. Below are links to the presentation slides (eeDAP is discussed from slide 23-29) and a paper we wrote describing it. eeDAP has been updated since the paper to work with other cameras, stages, and proprietary file formats.

 

What is an MDDT? Here is FDA/CDRH draft guidance on the MDDT program: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm374427.htm

 “An MDDT is a scientifically validated tool - a clinical outcome assessment (e.g. patient-reported or clinician-reported rating scales), a test used to detect or measure a biomarker (e.g. assay for a chemical analyte or medical imaging method), or non-clinical assessment method or model (e.g. in vitro, animal or computational model) - that aids device development and regulatory evaluation. Qualification reflects CDRH’s expectation that within a specified context of use1, the results of an assessment that uses an MDDT can be relied upon to support device development and regulatory decision-making.”

 

The MDDT submission and qualification process are not drastically different from a medical device submission, except the purpose of the MDDT is to *support* regulatory decision-making (an MDDT is not a medical device). An MDDT gets reviewed by FDA/CDRH pretty much like a medical device would get reviewed.

“Once an MDDT is qualified for a specific context of use, FDA’s expectation is that it can be used by any medical device developer for that context of use. CDRH reviewers should accept the MDDT for the qualified context of use without the need to reconfirm the suitability of the MDDT.”

 

For the benefit of the WSI WG community (and beyond), I am willing to document the process of qualifying eeDAP as an MDDT on our group page, share submission materials and feedback, and involve other groups and individuals on the submission. I and my colleague Marios Gavrielides are also willing to support another group or individual in the qualification of another MDDT. For example, we could identify a context of use for the micro beads or for another calibration slide.

 

If you have any questions, would like to be involved, or have ideas for your own MDDT, email me personally or comment at the blog.
https://nciphub.org/groups/wsi_working_group/blog/2016/10/fdacdrh-medical-device-development-tool

Progress updates will follow.

 

Brandon D. Gallas, PhD
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

 

Thanks to all that attended and contributed to our meeting at Pathology Informatics Summit last week. We are starting to reflect the "working" part of our working group. Below you will find a short synopsis of the meeting, then links to the agenda, presentation slides, and a recording of the meeting.

 

We also want to thank API for the meeting space, and for the AV and IT we thank the FDA's Office of Science and Engineering Labs, Division of Imaging, Diagnostics, and Software Reliability. There is no meeting without this support.

 

The first part of the meeting focused on using phantom slides created from depositing micro-beads. Sjef Box from Philips outlined how to build the slides with the beads and use them to understand focus properties of WSI scanners. He discussed a design for the slides and offered to share slides and send them to WSI working group members to investigate and collaborate on WSI technical evaluation methods. In a follow-up presentation Uwe Horchener from Roche provided examples of phantom-derived metrics of WSI image quality. Collaborative plans were already being made with some of the attendees. We hope to hear updates on this work over the summer and possibly a more purposeful project plan. To participate in these investigations, please contact Sjef at sjef.box@philips.com.

 

The second part of the meeting focused on feature and reproducibility studies. These studies provide a bridge between WSI technical and clinical performance assessment. Elizabeth Little from Roche introduced this topic in her presentation. These studies involve pathologists and tissue, but they strip away the clinical context by reducing the task to something simple like identification, enumeration, or scoring of individual features. They are not the broad-scope real-world clinical studies that we are used to seeing, as those discussed in Marios Gavrielides’ (FDA) presentation. Instead these studies are designed to stress the WSI scanner, reduce as much as possible confounding sources of variability from cases and readers, and inform on system and subsystem characterization and optimization. Vipul Baxi (Omnyx) outlined a study focusing on the assessment of multiple features from regions of interest.  Brandon Gallas from the FDA described analysis methods for feature studies and a hardware/software evaluation environment (eeDAP) for collecting feature study data from the exact same fields of view in digital and microscope modes. He is looking for collaborators and sites for a study to compare intra- and inter-reader agreement of mitotic counting. He offered to loan and install an eeDAP system to study collaborators. Brandon can be contacted at brandon.gallas@fda.hhs.gov.  In his feedback and expand presentation, Allen Olson (Leica) outlined a feature study with a human in the loop providing qualitative assessments of focus error. 

 

The synopsis above was meant to pique your interest in what happened. If it did, you can find out more at the member section of our group site.
All the presentations can be found at https://nciphub.org/projects/wsiwgproject/files/browse?subdir=20160522%20PathologyInformatics
Stream recording: https://fda.webex.com/fda/ldr.php?RCID=7399abd193734dcfd74663d4d14dd1af
Download recording: https://fda.webex.com/fda/lsr.php?RCID=c02bcdeb61f73eb241f77d469c0e7d8c

 

We hope to see you soon. How about Pathology Visions … ?

Reminder:

3rd Face-to-Face Meeting at Pathology Informatics 2016
Wyndham Grand Pittsburgh Downtown, Pittsburgh, PA

Sunday May 22, 2016
King's Garden 3
1:30-5:00 pm (new time)

Link to FINAL AGENDA
Link to WebEx Info

 

Agenda

 

  • 1:30 PM
    • Welcome (5 minutes)
      Brandon D. Gallas, PhD
      FDA/CDRH/OSEL/Division of Imaging, Diagnostics, Software Reliability
  • 1:35 PM
    • “Microbeads and focus quality test” (25 minutes)
      Sjef Box, MS
      Philips Digital Pathology Solutions
    • Feedback and expand: Uwe Horchner, PhD (15 minutes)
      Roche Tissue Diagnostics
    • Open Discussion (10 minutes)
  • 2:25 PM
    • Break (15 minutes)
  • 2:40 PM
    • “Reproducibility/Feature Studies: Objectives and Scope” (15 minutes)
      Elizabeth Little, PhD
      Roche/Ventana
    • Feedback and expand: Marios Gavrielides, PhD (15 minutes)
      FDA/CDRH/OSEL/Division of Imaging, Diagnostics, Software Reliability
  • 3:10 PM
    • “Reader-based Feature Study” (25 minutes)
      Vipul Baxi, MS
      Omnyx
    • Feedback and expand: Kathryn Espig, MS (15 minutes)
      Healthcare Division, Barco Inc.
    • Open discussion (10 minutes)
  • 4:00 PM
    • “Mitotic Counting Reproducibility/Feature Study With Pathologists” (25 minutes)
      Brandon D. Gallas, PhD
      FDA/CDRH/OSEL/Division of Imaging, Diagnostics, Software Reliability
    • Feedback and expand: Allen Olson, PhD (15 minutes)
      “Feature Based Focus Accuracy Study”
      Leica Biosystems
    • Open discussion (10 minutes)
  • 4:50 PM

Next Steps and Close (10 minutes)
Darren Treanor, MD
Leeds Teaching Hospitals NHS Trust and University of Leeds
 

In case you missed the AidPath Industrial workshop on digital pathology April 25, 2016: “Image quality in digital pathology from slide acquisition to visualization.” The host Cedric Marchesshoux has uploaded the talks and the agenda to our blog.

https://nciphub.org/groups/wsi_working_group/blog/2016/05/filespresentations-of-the-one-day-workshop-at-barco-headquarters-kortrijk-belgium-25th-of

Here are our planned speakers and talks. Will you be a reviewer?

Each reviewer is assigned a presentation to review. The reviewers get the presentation slides ahead of the meeting and prepare feedback for the speakers to be presented immediately following the presenter (~ 10 minutes). This feedback is similar to a journal review and leads to a great discussion. We hope you will participate. Contact brandon.gallas@fda.hhs.gov if you are interested.

 

Sjef Box, MS, Philips Digital Pathology Solutions

  • “Microbeads and focus quality test”

Vipul Baxi, MS, Omnyx

  • “Reader-based Feature Study”

Brandon D. Gallas, PhD, FDA/CDRH/OSEL/Division of Imaging, Diagnostics, Software Reliability

  • “Mitotic Counting Reproducibility/Feature Study With Pathologists”

 

Where and when:

3rd WSI Working Group Open Meeting (at Pathology Informatics Summit + WebEx)
1:30 - 5:00 pm, Sunday May 22
King's Garden 3, Wyndham Grand Pittsburgh Downtown

WebEx info here

 

Hope to see you then and there.

Please Join Us!

3rd WSI Working Group Open Meeting (at Pathology Informatics Summit + WebEx)
1:30 - 5:00 pm, Sunday May 22
King's Garden 3, Wyndham Grand Pittsburgh Downtown

 

Agenda will include scientific presentations and discussions on
    Phantom Slides
    Feature/Reproducibility Studies with Pathologists
Detailed agenda will be posted to the blog when it is final.

 

We are looking for volunteers to prepare feedback for three presentations. Slides will be provided about two weeks ahead of the meeting. Please contact brandon.gallas@fda.hhs.gov if you are interested.

 

WebEx Info is below.Audio is by phone call in.

 

-- Do not delete or change any of the following text. --

You scheduled this meeting.

Meeting ID: 746 984 360

Meeting Password: 3017962531

 

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

To start this meeting

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

1. Go to https://fda.webex.com/fda/j.php?MTID=m49ae5429b907810be4f4762a78253327

2. If you are not logged in, log in to your account.

 

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

Teleconference information

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

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.

 Cisco Unified MeetingPlace meeting ID: 746 984 360

 Cisco Unified MeetingPlace profile number for meeting host: 42819443

 

Technical support:

Contact FDA Rich Media at 301-796-3333.

 

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. You should inform all meeting attendees prior to recording if you intend to record the meeting. Please note that any such recordings may be subject to discovery in the event of litigation.

 

Note — No sensitive FDA data (i.e. PII, hostname/IP addresses, etc) should be recorded and saved during Webex session.

UPDATED LINK

The link is updated to point to the actual guidance document pdf.

 

BREAKING NEWS

Posted Today! The digital pathology final guidance for ...

"Technical Performance Assessment of Digital Pathology Whole Slide Imaging Device." LINK to PDF

 

Enjoy. Sorry for any confusion.

RE: Participate in WSIWG meeting at Pathology Informatics

 

Greetings all. We would like to build on our efforts last year to drive towards widely accepted approaches to measure technical and pathologist performance for whole slide imaging. To this end, we are planning a session at Pathology Informatics similar to what we did at Pathology Informatics and Pathology Visions last year. Depending on interest, we propose that one topic of this meeting be on "phantom slides" and another topic be on studies with pathologists (reproducibility studies, feature studies, narrow task).

 

You have important things to contribute and we want you involved. If you have something you would like to present on the topics mentioned above, please send an outline to Brandon.Gallas@fda.hhs.gov before April 4. We would like the presentations to show the phantom or the study images, discuss the measurements and collection, outline the analysis methods, and present real or hypothetical results. We hope to again enlist reviewers to prepare feedback for the presenters at the meeting. For example, the phantom session could include two 20-min presentations each followed by one or two reviews and open discussion.

 

Tentative Pathology Informatics Meeting agenda:

  • Sunday 22 May 2016 starting around 4-6pm (Free and open to the public + Web broadcast)
  • Phantom slides ~ 1 hour
  • Studies with Pathologist  ~ 1 hour 
  • Wiki Page ~ 30 mins

 

We look forward to hearing from you and seeing you in Pittsburgh. Thank you,

The WSIWG organizing committee

https://nciphub.org/groups/wsi_working_group/members?filter=managers

Upcoming Events: Pathology Informatics and Industrial Workshop (AIDPATH)

 

22 May 2016 @ Pittsburgh, PA, US.

The WSI WG is again organizing a session on the Sunday immediately preceding the Pathology Informatics Summit.

Mark your calendar. More information on how to attend and participate will be coming soon (free and open to the public).

We plan to emphasize technical measurements using manufactured phantom slides.

 

25 April 2016 @ Barco, Kortrijk, Belgium.

Barco is organizing an industrial workshop on digital pathology.

Workshop title: “Image quality in digital pathology from slide acquisition to visualization”.

This is in the context of the European AIDPATH project (http://aidpath.eu/4workshop).

The workshop is free and the cost expenses for external speakers will be covered by the project.

 Registration at:  http://aidpath.us8.list-manage2.com/subscribe?u=98b4f128f69adfd867c465ab9&id=bca03d662a

 Some travel information is can be found on: http://aidpath.eu/4workshop/venue.html

 The program will be updated with further details soon.

FYI: SPIE Medical Imaging Conference next week in San Diego

For those of you that don't know about the SPIE Medical Imaging conference, it is a great place for state-of-the-art research on several medical imaging topics that you might be interested in, including Digital Pathology since 2013. While the conference has a strong emphasis in Radiology, it has included broader topics very relevant to the digital pathology community for more than a decade:
Image Perception, Observer Performance, and Technology Assessment
Computer-Aided Diagnosis
Image Processing

Of personal note, Marios and Brandon will be at the conference and would enjoy talking about the evaluation of Digital Pathology. Please say hello if you are at the conference. Brandon is presenting a talk on the treatment of reader and case variability in agreement studies, such as would be useful comparing mitotic counting with WSI to counting on a microscope (https://spie.org/MI/conferencedetails/medical-image-perception).

Perhaps this email is too late to get your participate this year, but maybe you would like to mark your calendar for next year. Here is the full list of SPIE MI tracks:
Physics of Medical Imaging
Image Processing
Computer-Aided Diagnosis
Image-Guided Procedures, Robotic Interventions, and Modeling
Image Perception, Observer Performance, and Technology Assessment
Biomedical Applications in Molecular, Structural, and Functional Imaging
PACS and Imaging Informatics: Next Generation and Innovations
Ultrasonic Imaging and Tomography
Digital Pathology

Here is a link to the conference web site.
http://spie.org/conferences-and-exhibitions/medical-imaging

Title: FDA Regulation for WSI - An Update by the DPA Regulatory Taskforce

In case you are interested, the DPA is hosting a webinar next week with an interesting title, "FDA Regulation for WSI - An Update by the DPA Regulatory Taskforce." Here is a link to more info: http://hosted.verticalresponse.com/866781/71eff1b996/1704820913/d9ca562009/

 

Happy New Year! We discussed our hopes for this year. At the top of our list was the listing and prioritization of challenges for WSI and WSI evaluation measurement methods. We think the wiki under development will be important to this end as will face-to-face meetings (very successful last year). We hope you will contribute to both and that we will enjoy some good discussions.

 

Health and happiness in 2016.
The WSI Working Group Organizing Committee

T-con: WSI WG wiki (WebEx info attached)

Agenda: We will talk about the evolution of the wiki, assign additional topics to be covered in the 10 minute format, and plan future drill-down presentations on phantoms and tissue coverage. This T-con is open to the general WSI WG membership as we engage everyone to help build the wiki.

Please find this message archived on the WSI WG blog at https://nciphub.org/groups/wsi_working_group/blog/2015/11/t-con-wsi-wg-wiki

Add a comment to this blog item if you have any suggestions for the agenda.

 

 

 

-- Do not delete or change any of the following text. --

You scheduled this meeting.

 

Meeting ID: 741 082 522

Meeting Password: 3017962531

 

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

To join this meeting

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

1. Go to https://fda.webex.com/fda/j.php?MTID=mb8ae71fe1be6277b802da51ec6291de1

2. If you are not logged in, log in to your account.

 

 

 

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

Teleconference information

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

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.

 Cisco Unified MeetingPlace meeting ID: 741 082 522

 Cisco Unified MeetingPlace profile number for meeting host: 42819443

 

Technical support:

Contact FDA Rich Media at 301-796-3333.

 

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. You should inform all meeting attendees prior to recording if you intend to record the meeting. Please note that any such recordings may be subject to discovery in the event of litigation.

 

Hi Everyone.

 

We are rolling out a wiki to build a knowledge base for the WSI WG. Check out the main page for our first draft of the purpose, status, and process. https://nciphub.org/groups/wsi_working_group/wiki

 

The rest of the wiki is largely empty. It contains a few random pages created as the WSI WG organizers tested out this mechanism for moving the group forward. It also contains a few pages that begin to build some organization for the wiki to grow into.

 

We believe that the wiki will allow us to build a knowledge base that is aligned with our goals for the WSI WG, allows all interested parties to participate as authors or consume as readers, and is less complicated than managing the creation and revision of one or more documents by a large group.

 

We encourage you to help us create this WSI WG wiki. Leave some comments, create or edit some pages, or email us.

 

Thanks,

The WSI WG Organizers

The Pathology Visions presentations have been uploaded to WSI WG project page.
https://nciphub.org/projects/wsiwgproject/files

Please check them out, especially if you missed the meeting. You might want to start by reviewing the agenda and the introduction.

The meeting was quite successful, and we agreed to build on what we started. Specifically, we agreed to grow the list of topics (measurement methods and materials), and then plan for in-depth scientific-sharing discussions in the spirit of our meeting at Pathology Informatics last May (presenters and peer-reviewers). These discussions may even be based on data collection by the reviewers under the guidance of the presenters.

 

Stay tuned while we discuss the mechanisms for our next steps.

The WSI WG organizing team

Agenda and WebEx information for our session tonight. See below or this link https://nciphub.org/groups/wsi_working_group/blog/2015/10/webex-info-included-technical-performance-assessment-of-wsi-joint-session-between-dpa-and-the-wsi

 

When: Monday, October 12th, 6:30-9PM

Title: Technical Performance Assessment of WSI: Joint Session Between DPA and the WSI Working Group. 
Open to the public.

Abstract: This working session will review and discuss the draft guidance for industry and FDA staff “Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices” (TPA) published on February 25, 2015. This will be the first of several working group sessions to determine best practices regarding Whole Slide Imaging (WSI) system technical performance measurements. The ultimate goal will be to share existing knowledge and technical experience with WSI systems

Objectives:

  • Prioritize the components listed in the TPA in regards to the order that they will be addressed in future working sessions.
  • Assign DPA and WSI presenters and reviewers that will address the priority components at the next working session.
  • Identify future venue for the next working session.

 

-- Do not delete or change any of the following text. --

You scheduled this meeting.

 

Meeting ID: 746 209 182

Meeting Password: 3017962531

 

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

To start this meeting

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

1. Go to https://fda.webex.com/fda/j.php?MTID=m918d94dc6b764d84107fbe945ca34cc7

2. If you are not logged in, log in to your account.

 

 

 

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

Teleconference information

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

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.

 Cisco Unified MeetingPlace meeting ID: 746 209 182

 Cisco Unified MeetingPlace profile number for meeting host: 42819443

 

Technical support:

Contact FDA Rich Media at 301-796-3333.

 

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. You should inform all meeting attendees prior to recording if you intend to record the meeting. Please note that any such recordings may be subject to discovery in the event of litigation.

 

Did you miss the announcement about our session at Pathology Visions?

Here is the official announcement from DPA:
http://hosted.verticalresponse.com/866781/861992b286/1704805345/c67e8321f6/

 

Below you will find session information: date, time, title and session description, and WebEx information.
If you are unable to attend, you can use WebEx to follow along on your computer (to see slides) and telephone (to hear the speakers).

 

When: Monday, October 12th, 6:30-9PM

Title: Technical Performance Assessment of WSI: Joint Session Between DPA and the WSI Working Group. 
Open to the public.

Abstract: This working session will review and discuss the draft guidance for industry and FDA staff “Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices” (TPA) published on February 25, 2015. This will be the first of several working group sessions to determine best practices regarding Whole Slide Imaging (WSI) system technical performance measurements. The ultimate goal will be to share existing knowledge and technical experience with WSI systems

Objectives:

  • Prioritize the components listed in the TPA in regards to the order that they will be addressed in future working sessions.
  • Assign DPA and WSI presenters and reviewers that will address the priority components at the next working session.
  • Identify future venue for the next working session.

 

 

-- Do not delete or change any of the following text. --

You scheduled this meeting.

 

Meeting ID: 746 209 182

Meeting Password: 3017962531

 

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

To start this meeting

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

1. Go to https://fda.webex.com/fda/j.php?MTID=m918d94dc6b764d84107fbe945ca34cc7

2. If you are not logged in, log in to your account.

 

 

 

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

Teleconference information

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

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.

 Cisco Unified MeetingPlace meeting ID: 746 209 182

 Cisco Unified MeetingPlace profile number for meeting host: 42819443

 

Technical support:

Contact FDA Rich Media at 301-796-3333.

 

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. You should inform all meeting attendees prior to recording if you intend to record the meeting. Please note that any such recordings may be subject to discovery in the event of litigation.

In case you missed it, DPA has announced our session: I don't see it on the agenda, but you can see the announcement here: Click to view the announcement in a browser

Before the meeting we will be sharing more information about the session. This information will give you a chance to be more than just an audience member. We want you to impact the direction of the science-sharing seminars and contribute to the science-sharing seminars.

WebEx information also coming. Stay tuned.

The WSI Working Group Organizing Committee

---

Technical Performance Assessment of WSI:
Joint Session Between DPA & WSI Working Group
Monday, October 12, 2015 | 6:30 PM EST 

This working session will review and discuss the draft guidance for industry and FDA staff “Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices” (TPA) published on February 25, 2015. This will be the first of several working group sessions to determine best practices regarding Whole Slide Imaging (WSI) system technical performance measurements. The ultimate goal will be to share existing knowledge and technical experience with WSI systems

Objectives:

  • Prioritize the components listed in the TPA in regards to the order that they will be addressed in future working sessions.
  • Assign DPA and WSI presenters that will address the components identified as a priority for the next working session.
  • Identify future venue for the next working session.

Click to view this email in a browser