(73 days)
The Pain Management Optima is intended for use in Radio-Frequency (RF) heat lesion procedures for relief of pain.
The Pain Management Optima is a sterile, single-use cannula with an integrated probe used to deliver Radio-Frequency (RF) energy.
The provided text is a 510(k) summary for the Pain Management Optima device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
The document explicitly states that the "indications for use of the Pain Management Optima are identical to the BMC RF Cannula" and that "The fundamental scientific technology of both these devices is also the same." This suggests that the substantial equivalence argument relies on the similarity to the predicate device and does not require new clinical performance studies to be submitted within this 510(k) summary.
Therefore, I cannot provide the requested information from the given text because it is not present.
§ 882.4725 Radiofrequency lesion probe.
(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).