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Permacol® Surgical Implants are intended for use to support/reinforce soft tissue in surgical procedures. Permacol® Surgical Implant T-pieces are shaped for use in rectal intussusception repair and Permacol® Surgical Implant Rectocele-pieces are shaped for use in rectocele repair.

Permacol® T-piece and Permacol® Rectocele-piece are substantially equivalent to the predicate devices because they have the same intended uses and very similar technological characteristics.

The provided text is a 510(k) summary for the Permacol® Surgical Implant T-piece and Permacol® Surgical Implant Rectocele-piece. It primarily focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria and a study proving a device meets those criteria, as typically found in comprehensive performance studies for AI/software devices.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. The document states that "Biocompatibility and bench studies have been completed and support the safety and effectiveness" but does not detail the acceptance criteria or specific performance results of these studies in a format that would allow for the requested table and study description. It also explicitly refers to these studies being incorporated by reference, meaning the details are not contained within this particular submission.

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