JAMA Network
About The Study: Transparency of evidence supporting Food and Drug Administration (FDA) authorization of artificial intelligence (AI)- and machine learning -based devices for Alzheimer disease and related dementias was limited, precluding effective evaluation of training and validation dataset representativeness. Disease status (i.e., dementia type and distribution), age, and sex were reported for fewer than half of devices, while race and ethnicity data were rarely disclosed, raising uncertainty about real-world generalizability and clinical accuracy in intended populations.
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