(80 days)
The Radionics, Inc. RFG-3C Plus Radiofrequency Lesion Generator is intended to create lesions in nervous tissue.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device called the "RFG-3C Plus Radiofrequency Lesion Generator." This type of document does not contain information about acceptance criteria or a study proving that a device meets such criteria.
A 510(k) clearance is based on demonstrating substantial equivalence to a predicate device already legally marketed. It typically relies on comparisons of technological characteristics, indications for use, and performance data (often bench testing or animal studies, if human clinical trials are not required for substantial equivalence). It does not usually involve a detailed report of a study designed to meet specific acceptance criteria in the way an AI/ML medical device submission would.
Therefore, for your request, I cannot provide the specific details about acceptance criteria or a study that proves the device meets those criteria from this document. The information you're asking for is more typical of a clinical validation study for a novel device or an AI/ML algorithm, not a 510(k) for a device like a radiofrequency lesion generator from 1998.
§ 882.4400 Radiofrequency lesion generator.
(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).