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The Derrmalux® Tri-Wave MD 's use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.

The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The red light (633nm wavelength) is generally indicated for treatment of superficial, benign, vascular and pigmented lesions.

The near-infrared light (830nm wavelength) is generally indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

The Dermalux® Tri-Wave MD is a floor standing Class II medical device which emits specific wavelengths of low level, narrow band light for the treatment of dermatological conditions. The wavelengths used in the Tri-Wave MD system are Blue 415nm, Red 633nm and Near Infrared 830nm.

The device consists of a main body that contains the power supply, power switch, touch screen control panel, and a 4 panel adjustable treatment head that contains Light Emitting Diodes enabling treatment of the face and the body. The panels can be easily adjusted for focused intensity treatments and application to larger body areas.

The provided text is a 510(k) summary for the Dermalux® Tri-Wave MD device. It outlines the administrative information, device description, indications for use, and a comparison to a predicate device. However, it explicitly states under the "VII. PERFORMANCE TESTING" section:

• Animal: No studies were performed.
• Clinical: No studies were performed.

This means that the document does not contain information about a study that proves the device meets specific acceptance criteria based on clinical performance in humans or animals. The performance testing mentioned is "Bench Testing" which refers to verification of the device against design specifications and compliance with international and FDA-recognized consensus standards (e.g., electrical safety, electromagnetic compatibility, software lifecycle, photobiological safety, usability).

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance (as no performance studies are mentioned in a clinical context).
2. Sample size used for the test set and data provenance.
3. Number of experts used and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (algorithm only) performance was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This 510(k) summary focuses on demonstrating substantial equivalence through comparison to a predicate device and compliance with relevant safety and technical standards for a phototherapy system, rather than providing clinical efficacy or performance study data.

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