(80 days)
The Bipolar HF Cables are used to connect adequately equipped R. Wolf HF instruments to the corresponding HF devices.
The Bipolar HF Cables are used to direct a high frequency electrical current from an electrical generator made by unspecified manufacturers to a R. Wolf HF instrument.
This document describes a 510(k) submission for a Bipolar HF Cable. There is no mention of an AI device in the provided text. Therefore, I cannot generate the requested information about acceptance criteria and studies for an AI device.
The provided text pertains to a medical device, specifically a "Bipolar HF Cable," which is a physical cable used to connect medical instruments. The 510(k) summary focuses on demonstrating "substantial equivalence" to a previously cleared device, not on evaluating the performance of an AI algorithm.
Therefore, the categories listed in your request (such as sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set, etc.) are not applicable to this document as it does not describe an AI device or a study involving an AI algorithm.
§ 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.