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Intended to facilitate passage of a laparoscope through the anus allowing visual examination of the rectum and distal portions of the colon. Use of device is limited to non-sterile procedures where non-sterile laparoscopes are used.

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The provided document is an FDA 510(k) clearance letter for a medical device called "Trans-anal Introducer." It states that the device is "substantially equivalent" to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance testing, study design (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or ground truth establishment.

The letter is a regulatory document confirming clearance based on substantial equivalence, and it references the device's indications for use. It does not provide the detailed technical and clinical study data that would demonstrate how the device meets specific performance acceptance criteria.

Therefore, I cannot fulfill your request using the provided text. The information you are asking for (acceptance criteria table, study details, expert qualifications, etc.) would be found in the manufacturer's 510(k) submission, specifically the sections detailing the performance testing and clinical evaluations, which are not part of this public clearance letter.

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