Algo change significancy

Y

Yael LP

Registered
#1
#1
per MDCG2020-3, algo change is considered as a significant change.
Is it matter if it is algo change (lets say core functionality/ how algo works) or the algo itself remains same and only additional data is added to the training set to improve the AI/ML fit? This will affect the clinical outcome/effectiveness but the core algo is not affected
 
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Y

yodon

Staff member
Super Moderator
#2
#2
FDA published a proposed framework for managing modifications to AI/ML systems (that's not exactly the title). The paper nicely discusses both types of changes and lays out an approach to expectations for re-validating during continual learning. I don't believe I've seen any other regulatory body address it. And do bear in mind that this hasn't even been established as a draft guidance; just a proposed framework out for discussion. But I think it establishes a pretty reasonable approach.
 
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