(60 days)
The Axiom BioLaser LLLT Series-3 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
The Axiom Bio LLLT Series -3 is a non thermal triple diode infrared laser.
There is no information in the provided text regarding acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary and the FDA's clearance letter for the Axiom BioLaser LLT Series-3, which establishes its substantial equivalence to predicate devices for its intended use in temporarily relieving hand and wrist pain associated with Carpal Tunnel Syndrome.
Therefore, I cannot provide the requested information in the table or answer the specific questions about the study design, sample sizes, ground truth establishment, or multi-reader studies.
§ 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.