[tsbischof]

Could you provide a link to evidence obtained using your own device? Or perhaps a description of the tests you performed to determine substantial equivalence to the predicate devices?

[notamoletracker]

in what form do you want to get the data? I have a text from our researchers, but it's on Google drive. will this be significant for you?

[tsbischof]

I would be curious to see anything which lays out the specific claims and the evidence or justification used. For example, do you claim to detect malignant moles and if so what tests have you performed to demonstrate this. The language varies somewhat on your website so the approval documents or the information you described would be helpful to understand the device better.

[xlaacid]

I think what they want is an independent, double-blind study,using your device that show statistical significance detecting malignant moles.

[tsbischof]

Independent verification is not always performed for 510k submissions, but yes that would be ideal

[notamoletracker]

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