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COOLIEF* Radiofrequency Generator (CRG) System is indicated for use to create lesions during neurological lesion procedures and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The CRG is to be used with only AVANOS* and Diros RF Probes and accessories, such as Cooled / Standard RF Pain Management Probes, Cannulas, and Introducers. Use of the CRG System is limited to the indications cleared under these devices and accessories.

COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)

The provided text is an FDA 510(k) clearance letter for the COOLIEF* Radiofrequency Generator. It does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner requested (e.g., performance metrics, sample sizes, ground truth establishment, or expert qualifications).

The letter primarily:

• Acknowledges receipt and review of the 510(k) premarket notification.
• Determines substantial equivalence to legally marketed predicate devices.
• Outlines general controls provisions and other regulatory requirements applicable to the device.
• Specifies the "Indications for Use" for the device.

Therefore, I cannot provide a response with the information requested in your bullet points as it is not present in the given document.

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