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Sterile, singe-use electrosurgical accessory used in conjunction with Argon Beam Coagulation generator for delivery of argon gas and electrosurgical current to achieve cutting and coagulation of tissue.

The ABC Dissecting Electrodes are electrodes used in coniunction with an Argon Beam Coagulation generator. The system is designed to provide a controlled flow of argon to electrosurgical handsets. The handsets allow the clinicians to perform argon enhanced Electrosurgery in open and laproscopic procedures. The electrodes attach to several previously cleared ConMed Electrosurgery ABC® hand pieces to convert from Argon Beam Coagulation only to Argon Beam Dissect.

When cutting, the edge of the electrode shall be in contact with the tissue while being enclosed in an envelope of argon gas. The electrosurgical energy is passed through the electrode as it is drawn across the tissue. When coagulating, the accessory electrode is not in contact with the tissue and is separated from the tissue by distance for fulguration to achieve the desired result. The electrodes utilizes previously cleared/marketed generators and hand pieces.

This document describes the safety and effectiveness of CONMED ABC Dissecting Electrodes. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of a software algorithm or AI. Instead, it supports the substantial equivalence of this electrosurgical electrode to a predicate device based on technological characteristics and conformity to established standards for electrosurgical devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance in the context of an AI/software device. The provided text is for a physical medical device (electrosurgical electrodes) and does not describe any AI or algorithm that would require such performance studies.

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