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> AI developer performed no clinical validation nor that the FDA hasn't seen it

if the developer went through the trouble and expense of performing clinical validation you can be sure that they would publish the results __unless__ the results reflected negatively on them

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Given that the design and endpoints of clinical validation studies is priceless information for developers of similar devices (i.e., competitors) applying for FDA clearance via the 510(k) pathway, it would not surprise me at all if this information was purposefully kept secret no matter how flattering it is. Especially for relatively new technology like AI

I've been part of bringing many medical devices to market and this isn't true.

Sometimes they do publish the validation data, especially in pharma etc. Most times they don't, why would you? It would only help your competitors.

510(k) summaries are always a negotiation between FDA (which wants as much data as possible in them) and manufacturers (which want as little data as possible, as it is priceless competitive intelligence)

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