(134 days)
The POWER LASER 90 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
The POWER LASER 90 is a hand-held, battery operated, non-invasive, non-thermal, low energy, infrared laser, therapeutic medical device. A separate battery charger can recharge the battery when it is removed from the POWER LASER 90. POWER LASER 90 is a finished device, which is delivered packed with battery charger and complete labeling for the user.
I am sorry, but the provided text does not contain information on acceptance criteria or a study that proves the device meets acceptance criteria. The document is primarily a 510(k) summary and an FDA clearance letter for the "POWER LASER 90", establishing its substantial equivalence to a predicate device for the indication of temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
It mentions that "POWER LASER 90 as well as the battery charger demonstrates compliance to relevant safety-standards, EMC standards and standards for laser equipment," but it does not detail specific acceptance criteria for performance, nor does it describe any study (clinical or otherwise) conducted to prove the device meets such criteria.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.
§ 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.