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The most common model that we are putting in front of FDA several times per week for many companies is the AUROC model with minimum FDA requirements for specifi
by 5440 6y ago
The most common model that we are putting in front of FDA several times per week for many companies is the AUROC model with minimum FDA requirements for specificity and sensitivity. I have some concern that the commentators on this article aren't actually aware of how many of these ML based software packages are actually being cleared by FDA at the moment through the DeNovo and 510k processes.
- ska 6y agoThere are a lot more systems going through 510(k) for sure, partially due to new developments, but partially driven really by marketing. On the other hand there have been ML/AI systems since the mid-late 90s at least, and they haven't for the most part shifted clinical practice much. The reasons for this have not shifted radically in the last decade, although some are moving a bit now. FDA approval to market doesn't mean anything beyond you have an argument that you haven't introduced new risks (safe) and in at least some cases you can improve something without making others worse (efficacy) but this may in a very narrow indication. I guess my point is, the purpose of the FDA has never been to ask "does this really work better? should it be the new standard of care?", but rather to balance the risk in new technology or drugs against the potential reward. Even with a PMA it's risk reduction, not proof of how it will play out in the wider world if interactions and practice.