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The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.

Teleflex Medical's next generation Percuvance™ Percutaneous Surgical System is a micro-laparoscopic platform that comprises fourteen (14) unique components, which are combined in various configurations to create a multifunctional set of instruments for laparoscopic procedures to be performed in a hospital setting. In accordance with IEC 60601-1:2005 (A1:2012), this next generation Percuvance™ system is classified as an active accessory with a rated accessory voltage of 1000V peak-. System components include two reusable Handles (Ratcheted and Non-Ratcheted), which are manipulated by the surgeon and connect to a Shaft. The Shaft, which is available in two lengths (29 cm and 36 cm), affords various Tool Tips (or End Effectors) to be attached in order to perform basic surgical manipulation. Initial access to the surgical site is achieved with the Introducer Tool Tip attached to the Shaft. Once inside the patient, the Introducer Tool Tip is extracorporealized through a pre-inserted, central trocar and is then exchanged for one of the other Tool Tips, which include Scissors. Gripper Grasper, Johans Grasper, Maryland Dissector, Hook Cautery, Spatula Cautery and Clip Applier. Finally, the Seal Bridge, which is available in two sizes (5 mm and 12 mm), is used to protect the trocar seal and to aid in maintaining insufflation when it used in conjunction with a trocar to facilitate the extracorporeal exchange of Tool Tips.

This document is a 510(k) summary for the Teleflex Medical Percuvance™ Percutaneous Surgical System. It describes a medical device, but does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/algorithm performance evaluation.

The provided document details the substantial equivalence of a surgical system (not an AI/algorithm) to predicate devices through various bench tests, biocompatibility evaluations, and usability studies. It focuses on the physical and functional performance of the surgical tools themselves, not on the performance of a diagnostic or predictive algorithm.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert qualifications, etc.) for an AI/algorithm from this document.

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