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Every AI tool would have to report how well it works for women and men, different ethnic groups, ages, scanner types and hospitals, not just an overall score.
Cancer AI is often validated on populations that do not match deployment populations; performance gaps by skin tone (dermatology), breast density, ethnicity and scanner vendor are documented. The proposal requires, for clearance and in the model registry, performance reporting across a standard set of subgroups with minimum sample sizes and confidence intervals, and labelling restrictions where performance is unknown or inadequate.
Shares How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals, AI that is built but not validated or deployed.
Shares How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals, AI that is built but not validated or deployed.
Shares How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals, AI that is built but not validated or deployed.
Shares How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals, AI that is built but not validated or deployed.
Shares How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals, AI that is built but not validated or deployed.
Shares How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals, AI that is built but not validated or deployed.
Shares How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals, Mammography & tomosynthesis, AI that is built but not validated or deployed.
Shares How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals, AI that is built but not validated or deployed.