(34 days)
The ERBE Disposable Patient Return Electrodes are a key accessory in the efficacious application of HF surpical instruments and are intended to be used primarily with Erbe's range of Electrosurgical Generators but they are also compatible with generators from other manufacturers.
The Erbe electrodes and are to be sold with and without a pre-attached cable. Erbe will offer the Return Electrodes without the pre-attached cable as these provide the user the option of purchasing a less expensive item and utilizing a re-usable cable.
The provided document is a 510(k) Notification for the ERBE Disposable Patient Return Electrode from 1996. It is a summary of safety and effectiveness for a conventional medical device (an electrosurgical electrode), not an AI/ML-powered device. Therefore, the requested information regarding acceptance criteria, study details, and ground truth establishment, which are typical for AI/ML device evaluations, is not applicable and not present in this document.
The document focuses on demonstrating substantial equivalence to existing devices and technologies, common for a 510(k) submission for this type of device. It states that "The ERBE Disposable Patient Return Electrodes utilize the same materials and technology" as those manufactured by ConMed and that "there are no known adverse reactions or field problems with electrodes utilizing this technology or materials."
Therefore, it is not possible to provide the requested information based on the provided text. The prompt's questions are designed for AI/ML device evaluations, which involve different types of performance metrics and study designs compared to the conventional device described here.
§ 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.