(84 days)
General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of any FF (radio frequency) electrosurgical current through an accessor selectrode for cutting and coagulation at the operative site.
Not Found
This document is a 510(k) clearance letter for a medical device called the Conmed System 5000 ESU, not a study report. It states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, the document does not contain the information required to populate the acceptance criteria and study details you've requested. The request specifically asks for details about a study that proves the device meets acceptance criteria, including sample sizes, ground truth establishment, expert qualifications, and multi-reader comparative effectiveness; none of this information is present in a 510(k) clearance letter.
To fully answer your prompt, I would need access to the actual 510(k) submission (which often includes performance data and testing), or a separate study report for the Conmed System 5000 ESU.
§ 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.