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Does the FDA require performance data aside from Sensitivity and Specificity? For example, Precision and Accuracy performance? This is a new SAMD in General Hospital Review team. ------------------------------ Edward Panek VP, QA/RA Med Device USN Veteran Research into Neural Nets - https://www.twitch.tv/edosani ...

These events are best described as a spectrum of probability. I would look up the product code and show a histogram and develop and present a probability table for each segment of interest. ------------------------------ Edward Panek VP, QA/RA Med Device USN Veteran Research into Neural Nets - ...

With an AI De Novo submission underway And some experience in training AI to play chess with only the rules provided, I have a lot of questions about regulating the future of AI. For AI to provide value that means a process execution or treatment decision needs to change. A drug is administered ...

Thanks Olga and Anne! ------------------------------ Edward Panek VP, QA/RA Med Device USN Veteran Research into Neural Nets - https://www.twitch.tv/edosani ------------------------------

Does FDA or other regulatory bodies have any controls/oversight/reporting requirements for the Cell Phone application stores and if so what is the regulation number? Submitting a non-medical software application per FDA 2019 guidance on dashboards and Google accepted quickly. Conversely, Apple is ...