(239 days)
The Mygen V-1000 RF system is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.
Electrosurgical, cutting & coagulation device & accessories
I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Mygen V-1000 RF System" does not contain any information regarding acceptance criteria, study details (like sample size, ground truth, expert qualifications, or MRMC studies), or performance metrics beyond the simple statement of "substantial equivalence" to a predicate device.
The document is a standard FDA clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It outlines regulatory requirements, but it does not delve into the specific technical studies or performance data typically found in a clinical study report or a detailed 510(k) summary (which might be a separate, more extensive document).
Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and the study that proves the device meets them because that information is not present in the provided 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.