Identification of predicate creep under the 510(k) process: A case study of a robotic surgical device.

PLoS One · 2023 · PMC10047502 · PMID 36976820

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somewhat significantno p-value reported

Even in new versions of existing devices submitted by the same manufacturer, such as the Da Vinci Models IS1000 and IS1200, there can be somewhat significant technological changes.

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Quoted from the open-access full text in Europe PMC under the licence the publisher applied. The sentence is reproduced exactly as published; the emphasis is ours.