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The Laparoscopic Unipolar Tips will serve as accessories to the Endo-Tech, Ltd, Inc.,Endo-Aid, which is an Aspiration- Irrigation Device. These tips will thread into the laparoscopic irrigation and aspiration control handle. The tips will be used during laparoscopic procedures and electrosurgical procedures.

The Laparoscopic Unipolar Tips will be threaded into the Endo-Tech, Ltd., Inc. Endo-Aid (K#930756) and will be used during Laparoscopic procedures. These tips will be used by a range of surgeons for various abdominal procedures in a hospital operating room environment. The Laparoscopic Unipolar Tips consist of the following components: Threaded adapter (Male), Thread on probe and stainless tip (Female:Spatula, L Hook, J Hook, and Needle), Insulation Sheath for Electrosurgical Tips (Ratcheting).

This 510(k) submission (K961695) is for a medical device that does not involve AI/ML. There is no information in the provided text regarding acceptance criteria, device performance, sample sizes, expert involvement, or any studies related to AI/ML performance.

Therefore, I cannot provide a response with the requested information based on the provided text. The document describes a comparison to a predicate device based on physical and functional characteristics, not performance metrics usually associated with AI/ML systems.

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