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The RectoSight® RS 300-04 is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the rectal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures. The ProctoSight® PS 300-04 is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the anal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures.

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This document is a 510(k) clearance letter from the FDA for two devices, the RectoSight® RS 300-04 and ProctoSight® PS 300-04, which are video sigmoidoscopes. The letter states that the devices are substantially equivalent to legally marketed predicate devices. However, this document does not contain information about specific acceptance criteria, performance data, or details of a study that proves the device meets acceptance criteria.

Therefore, I cannot fulfill your request for the specific details outlined (e.g., acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) because that information is not present in the provided text.

The document only serves as an FDA clearance based on substantial equivalence, implying that the devices meet the performance of predicate devices, but it does not detail the specific studies or performance metrics used to make that determination.

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