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Reusable Hook, Coagulator is a electrical surgical instrument used in arthroscopic and laparoscopic surgical procedures.

Reusable Hook, Coagulator is a electrical surgical instrument

The provided text is a 510(k) clearance letter from the FDA for a device named "Fire Stick," which is described as a "Reusable Hook, Coagulator" used in arthroscopic and laparoscopic surgical procedures. This document is a regulatory approval and does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) clearance primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed study results with acceptance criteria and performance metrics in the way a clinical study report or a more comprehensive premarket approval (PMA) document would.

Therefore, I cannot provide the requested information based on the text provided.

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