(66 days)
The RadioTherapeutics Corp. RF Generator is a medium power electrosurgical generator intended for use with separately approved electrodes for the thermal coagulation of soft tissues.
RadioTherapeutics RF-2000 Radiofrequency Generator
I am sorry, but based on the provided text, there is no information available about acceptance criteria, device performance, or any studies conducted (such as standalone, MRMC, or those related to sample size, ground truth, or expert qualifications).
The document is an FDA 510(k) clearance letter for the RadioTherapeutics RF-2000 Radiofrequency Generator, indicating that the device is substantially equivalent to a predicate device for the thermal coagulation of soft tissues. This type of letter confirms regulatory approval to market the device based on substantial equivalence, but it does not typically include detailed performance study results or acceptance criteria.
Therefore, I cannot provide the requested table or answer the specific questions regarding studies, sample sizes, ground truth establishment, or expert involvement.
§ 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.