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The LuxIR is intended for photocoagulation of soft tissue in dermatologic applications. It also provides 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, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The LuxIR Handpiece is an accessory to the StarLux™ Pulsed Laser and Light System. The complete StarLux Pulsed Light System consists of a cart, system console, chiller, a footswitch, and a handpiece. The Palomar LuxIR Handpiece emits energy in the infrared wavelength.

The provided text is a 510(k) summary for the Palomar LuxIR Handpiece. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel device.

Therefore, the requested information, particularly regarding specific acceptance criteria, a detailed study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a training set, is not present in the provided document.

The document states:

• "The review of the performance data provided in this notification demonstrates that the modified LuxIR Handpiece is substantially equivalent to its predicate device." This indicates that the performance review likely focused on comparing the new device's characteristics to the predicate, not on setting new performance criteria and testing against them from scratch.
• "The modified LuxIR Handpiece was found to be substantially equivalent to its predicate device because it shares identical indications for use, substantially similar technical characteristics, and operation." This further emphasizes the comparative nature of the assessment.

Without a detailed clinical study report or a different type of performance evaluation document, it's impossible to fill out the table and answer the specific questions you've posed. The 510(k) summary aims to argue for equivalence, not to present a de novo performance study with specific metrics and acceptance criteria for a new device type.

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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.

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