(88 days)
Peripheral nerve stimulate electrically a peripheral nerve in patients to relieve severe intractable pain. In order to maintain consistency between products, this indication will be used for all Medicated devices.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a Peripheral Nerve Stimulator for Pain. It outlines the regulatory approval for marketing the device based on substantial equivalence to predicate devices.
However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The letter is a regulatory approval, not a technical report detailing the performance evaluation of the device.
Therefore, I cannot provide the requested information from the given input.
§ 882.5870 Implanted peripheral nerve stimulator for pain relief.
(a)
Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).