(63 days)
The PAIN-X-2000 is indicated for use to emit energy in the Infrared Spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device named PAIN-X-2000. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this letter does not contain any information regarding specific acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information about sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, or training set specifics based on this document.
The document only states the device's indications for use: "to emit energy in the Infrared Spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature." It then confirms its regulatory classification and allows it to be marketed.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.