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Common Name: Circumcision Clamp

Circumcision Clamp

The provided text is a 510(k) summary for a medical device called EZ-CIRC, a circumcision clamp. It explicitly states that the safety and effectiveness determination is based on a predicate device, the Mogan clamp, which was legally marketed prior to May 28, 1976.

This summary does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement for the EZ-CIRC device itself. The 510(k) process for this type of device often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical studies with detailed performance metrics as would be expected for novel AI-powered diagnostic devices.

Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided text. The document is solely focused on identifying the device, its classification, and its predicate.

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