(186 days)
Disposable Endoscopic Bipolar is a sterile, single use electrosurgical instrument intended to conduct electrosurgical current for coagulation of tissue during general surgical procedures.
Disposable endoscopic bipolar consists of electrode, power line, socket, handle group, inner rod, pushrod. Handle group consists of block, set screw, handle, fixed block, rivet pin, rivet cap, connecting rod, sliding block, spring, front insert, upper cover, lower cover, tail sleeve. The inner rod is set in the pushrod and handle group mechanism, and is fixed with set screws and fixed block, and the pushrod is connected to the sliding block. The back end of the push rod is shaped like a semi-circle for easy bending and use. The product is divided in straight and curved based on poshrod shape type. The electrodes are equipped with the insulating sleeve, and the outer side of the sleeve is provided with a stainless steel armor plate to prevent the push rod from rubbing the sleeve. The electrodes are fixed in the inner rod. The electrodes are connected to the socket through power line, and the socket can be connected to the high frequency surgical equipment. Disposable endoscopic bipolar materials: Stainless Steel, Plastic Material.
The provided text does not contain information about acceptance criteria for an AI/ML device or a study proving its performance against such criteria. The document is a 510(k) premarket notification for a Disposable Endoscopic Bipolar device, which is a physical electrosurgical instrument, not an AI/ML software device.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from this document. The document describes the mechanical structure, principle of operation, and comparison of the subject device to a predicate device, focusing on electrical safety, biocompatibility, and sterilization, along with mechanical strength and thermal effects on tissue.
§ 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.