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The TroClose1200™ bladeless trocar is intended for use in a variety of gynecologic, general and urologic endoscopic procedures to create and maintain a port of entry and to facilitate the delivery of absorbable sutures and anchors through soft tissues of the body during endoscopic/ laparoscopic surgery. The trocar may be used with or without visualization for primary and secondary insertions

TroClose1200™ bladeless trocar

This document is a 510(k) clearance letter from the FDA for a medical device called TroClose™ / TroClose1200™. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter is a regulatory approval, stating that the device is "substantially equivalent" to legally marketed predicate devices. This means the FDA believes it is as safe and effective as existing devices on the market, but it does not detail performance metrics or studies in the way you've requested.

Therefore, I cannot provide the information you asked for based on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness, or the study report itself.

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