Draft Version
Brandon started out with a bunch of announcements and reminders:
Update on MDDT proposal
We got a preliminary response from FDA on the MDDT proposal. I have put it on the wsi working group blog (LINK).
- The response explains the delay in the full response and it provides a limited response to our question about providing only technical performance results in the MDDT, no reader study data.
- “We are open to discussing the COU and the associated evidence as discussions about the MDDT proceed. The criteria for qualification do not necessitate clinical data, the evidence will primarily depend upon the MDDT and the context of use.“
- They say a full response will be coming within two weeks. This would be in time for us to discuss at Pathology Informatics.
- Will someone revise the MDDT proposal such that the supporting evidence would only be technical performance data (registration accuracy and color reproduction)?
Some project members have run eeDAP
- IIT was the first. Philips was the second. Have you tried? Let Brandon know. It is the first step to running an eeDAP study.
- We have archived the questions and responses that helped make this possible eeDAPregistrationquestions, eeDAPwithImageScope. We have also updated the user manual and provided fresh resources (sample WSI and corresponding eeDAP input file). You may want to scan these discussions if you struggle getting eeDAP running.
- We have uploaded two videos demonstrating eeDAP, including registration. Check them out here!
- eeDAP successfully opened BIGtif!
Registration Accuracy
* Qi Gong at the FDA has conducted preliminary registration accuracy studies. We have 1 failure out of 20 tasks/FOVs in “Fast Registation” mode. This failure is fixed when the “Best Registration” button is pressed. Except for the failure, we are within 2.5 microns. * First draft of slides outlining study can be found [here].