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Performance evaluation methods for improvements at post-market of artificial intelligence/machine learning-based computer-aided detection/diagnosis/triage in the United States

Table 1

Characteristics of the 8 devices improved at post-market in the USA.

RT, Reader study testing; SA, Software standalone testing; DL, Deep learning. ※Submission interval = Submission Date -Approval Date.

doi: https://doi.org/10.1371/journal.pdig.0000209.t001