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The Laparoscopic Handles with PEEK Insulation are indicated for use in endoscopic surgical procedures through cannulae to perform cutting, dissecting, retracting, and manipulating functions.

Laparoscopic surgical manual instruments (containing a Laparoscopic Handle with PEEK Insulation and manual instrument insert) are intended for cutting, holding, grasping and manipulation of tissue, organ areas, and surgical auxiliaries such as suturing material. Some instruments have radiofrequency (RF) ports which allow them to be used for electrosurgery. The Laparoscopic Handles with PEEK Insulation (herein referred to as 'proposed device') can be used in combination with the predicate 5 mm inserts cleared in K973259. The proposed devices are designed to be sterilized by the end user using either the US or EU standard pre-vacuum sterilization cycles.

This document is a 510(k) premarket notification for a medical device (Laparoscopic Handles with PEEK Insulation). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study or AI model performance evaluation. Therefore, most of the information requested in your prompt is not available in these documents.

Here's the information that can be extracted, and an explanation of why other requested information is not present:

1. A table of acceptance criteria and the reported device performance

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