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Pathology AI is cleared on uneven evidence, often without showing that pathologists using it do better than without. The proposed standard has two stages: a pre-registered, fully crossed multi-reader multi-case study comparing pathologist plus AI with pathologist alone, then a prospective deployment study measuring turnaround, tumour board discordance and treatment changes.
Pathology AI is cleared on varied evidence, often without showing that pathologists using it perform better than without. The proposal is a standard two-stage pathway: a multi-reader multi-case study with a fully crossed design, pre-registered and adequately powered, measuring pathologist-plus-AI versus pathologist alone on diagnostic accuracy and time; then a prospective deployment study measuring turnaround, discordance at tumour boards, and downstream treatment changes, all reported to the registry.
Shares PathAI, Paige AI, AI that is built but not validated or deployed, Digital pathology & AI.
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Shares PathAI, Paige AI, 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 PathAI, Paige AI, AI quantification of HER2-low and HER2-ultralow, 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, Digital pathology & AI.
Shares PathAI, Paige AI, Digital pathology & AI, Histopathology & immunohistochemistry.
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, Digital pathology & AI.
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.