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The Transvaginal Doppler Clamp is intended for bilateral detection and temporary occlusion of the uterine arteries during conservative gynecological surgery such as laparoscopic myomectomy.

Transvaginal Doppler Clamp

This document is a 510(k) clearance letter from the FDA for a medical device called the "Transvaginal Doppler Clamp." It does not contain any information about acceptance criteria, device performance, studies, sample sizes, expert qualifications, or ground truth establishment.

The letter explicitly states that the clearance is granted on the condition that the manufacturer submits a "postclearance special report" which "should contain complete information, including acoustic output measurements based on production line devices." It also notes that if this report contains "unacceptable values," the 510(k) clearance may not apply. This implies that performance testing and acceptance criteria for acoustic output will be evaluated after this clearance, not before.

Therefore, I cannot fulfill your request using the provided text. The document is an administrative notification of substantial equivalence, not a summary of device performance studies.

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