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by xlaacid 1834 days ago
I think what they want is an independent, double-blind study,using your device that show statistical significance detecting malignant moles.
1 comments

Independent verification is not always performed for 510k submissions, but yes that would be ideal
it's great that you asked about clinical trials. we conducted them blindly, with the participation of several doctors. the device measured the mole, and then it was examined by a doctor. after that, a biopsy and histology were performed. these data were compared. now this data is unstructured and the histology documents contain personal data of people. but I will soon process everything and also post it on the site. I didn't think it was interesting. everyone needs FDA and 510k certificates