(50 days)
The Lesion Probe and Generator system is intended to create radiofrequency (RF) heat lesions in nerve tissue. It is intended for use only by trained clinicians in a hospital or clinical setting.
The GFX Nerve Ablation System provides a minimally invasive technique for creating a neural lesion inhibiting the function of the target nerve. The Generator and probe are used as a system to both stimulate the nerve for the purpose of locating the probe correctly and to create a neural lesion to inhibit nerve function through the application of RF energy. The GFX Nerve Ablation probes are single use devices supplied sterile to the customer.
The provided text is a 510(k) summary for the GFX Nerve Ablation System. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, this document does not contain the detailed information required to answer your specific questions about acceptance criteria and the comprehensive study proving the device meets those criteria.
The "Summary of Testing" section (Section 6) simply states: "Device integrity and functionality were verified and/or validated using samples produced under routine manufacturing conditions." This is a very high-level statement and does not provide any of the specifics requested.
Therefore, I cannot populate the table or answer the specific questions because the necessary data is not present in the provided document.
To answer your request, I would need a different type of document, such as a detailed study report or a more comprehensive technical file submission, which would outline the specific tests performed, their acceptance criteria, results, sample sizes, ground truth establishment, and statistical analyses.
§ 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).