PubMed

FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks.

PMID: 37625896 · 2023

U, r, s, , J, , M, u, e, h, l, e, m, a, t, t, e, r, ;, , C, h, r, i, s, t, i, a, n, , B, l, u, e, t, h, g, e, n, ;, , K, e, r, s, t, i, n, , N, , V, o, k, i, n, g, e, r

ZeitschriftThe Lancet. Digital health

Jahr2023

PMID37625896

Zusammenfassung

The US Food and Drug Administration is clearing an increasing number of artificial intelligence and machine learning (AI/ML)-based medical devices through the 510(k) pathway. This pathway allows clearance if the device is substantially equivalent to a former cleared device (ie, predicate). We analysed the predicate networks of cleared AI/ML-based medical devices (cleared between 2019 and 2021), their underlying tasks, and recalls. More than a third of cleared AI/ML-based medical devices originat

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