(87 days)
General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of a RF (radio frequency) electrosurgical current through an accessory electrode for . cutting and coagulation at the operative site.
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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the Conmed System 2000 ESU, an electrosurgical generator. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations. However, it does not include details on specific acceptance criteria, study designs, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for a device performance study.
Therefore, I cannot extract:
- A table of acceptance criteria and reported device performance.
- Sample sizes used, test set data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Information on MRMC comparative effectiveness studies or effect sizes.
- Information on standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.