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510(k) Data Aggregation
(350 days)
Reprocessed Trocars and Cannulas are intended to open and maintain a port of entry during endoscopic procedures.
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I am sorry, but the provided text does not contain information about explicit acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA, confirming that certain reprocessed endoscopic/laparoscopic trocars and cannulas are substantially equivalent to legally marketed predicate devices.
While the letter mentions "supplemental validation data" was reviewed, it does not describe the specific acceptance criteria for that validation or the details of the study itself. It primarily focuses on the regulatory outcome (substantial equivalence) rather than the technical performance data.
Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert qualifications, or study design based on the provided text.
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