I think those are generally good questions but the majority of submissions that FDA CDRH are reviewing are for imaging of ultrasound, MRI, XRAY etc, with a spri

I think those are generally good questions but the majority of submissions that FDA CDRH are reviewing are for imaging of ultrasound, MRI, XRAY etc, with a sprinkling of audio AI and maybe some individualized vaccines predictions at CDER. These questions are generally addressed during the pre-sub for each FDA submission but I agree that the demographic information could be pretty infinite. I'm working on at least 5 of these AI submissions per week. For example, lets say you have an AI submission for identifying cardiac ultrasound images. FDA will ask for very specific demographic information in the training and performance tests, as well as comorbidities (such as hypertension) for each training image. In addition, they will want at least three physicians to annotate the images. The training dataset is likely to contain at least 100-200K images.