(318 days)
Reprocessed electrosurgical electrodes are intended to remove tissue and control bleeding during surgery by use of electrical current.
The devices that are the subject of this submission are used to remove tissue and control bleeding during surgery. They are made of a variety of materials and come in different shapes. They come from several different original equipment manufacturers as single use devices. Reprocessing includes cleaning. refurbishing, testing, packaging, and sterilization. It allows the electrodes to be used several times rather than just once.
The provided text is a 510(k) summary for reprocessed electrosurgical electrodes and an FDA clearance letter. It does not contain information regarding acceptance criteria, study performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or MRMC studies.
The document explicitly states: "Comparative performance testing and clinical evaluations were not included as part of this 510(k)." This indicates that a study demonstrating performance against acceptance criteria, as requested in the prompt, was not performed for this submission.
Therefore, I cannot provide the requested information from the given text.
§ 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.