FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks
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Date
2023-09
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Journal Article
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Abstract
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 originated from non-AI/ML-based medical devices in the first generation. Devices with the longest time since the last predicate device with an AI/ML component were haematology (2001), radiology (2001), and cardiovascular devices (2008). Especially for devices in radiology, the AI/ML tasks changed frequently along the device's predicate network, raising safety concerns. To date, only a few recalls might have affected the AI/ML components. To improve patient care, a stronger focus should be placed on the distinctive characteristics of AI/ML when defining substantial equivalence between a new AI/ML-based medical device and predicate devices.
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published
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5 (9)
Pages / Article No.
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Elsevier
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Software
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09853 - Vokinger, Kerstin Noëlle / Vokinger, Kerstin Noëlle
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Funding
197485 - Governance and legal framework for managing artificial intelligence (AI) (SNF)