(185 days)
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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.