(121 days)
The Palomar LuxIR Handpiece is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the Palomar LuxIR Handpiece may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The Palomar LuxIR Handpiece delivers infrared light with a wavelength of 800-1800 nm. The complete system consists of a power source, chiller, a footswitch, and a handpiece connected to the power unit with an umbilical. In standard use, the handpiece is held in firm contact with the skin. The handpiece tip is water-cooled to provide active skin cooling. System parameters and other system features are controlled from the user interface panel on top of the power unit.
The provided text describes the Palomar LuxIR Handpiece, an infrared handpiece intended for topical heating to temporarily relieve various types of pain and muscle issues. However, the document does not contain any information about specific acceptance criteria or a study proving the device meets those criteria, nor does it provide performance data.
Instead, the document is a 510(k) summary and the FDA's clearance letter, which focuses on demonstrating substantial equivalence to a predicate device (Cutera Optional Infrared Handpiece K033768).
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training and ground truth from the given text.
The "Performance Data" section explicitly states: "The differences in the specifications of the Palomar LuxIR Handpiece and the predicate device do not result in different performance or raise new questions of safety or efficacy." This indicates that a direct clinical performance study against specific acceptance criteria for the new device was not performed or deemed necessary for this 510(k) clearance, as its performance was inferred to be similar to the predicate device.
§ 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.