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• eLyx PRO is intended to emit in the blue and red region of the spectrum for use in dermatology for treatment of mild to moderate forms of acne
• eLyx PRO is intended to emit in the red and near-infrared region of the spectrum for use in dermatology for treatment of periorbital wrinkles
• eLyx PRO is intended to emit in the red and near-infrared region of the spectrum for the temporary relief of minor muscle & joint pain, arthritis and muscle spasm, and relieving stiffness

Elyx-PRO is a professional photomodulation device designed for use in health office. It offers 6 preprogrammed treatment protocols using Light Emitting Diodes (LED) technology. It is composed of a base unit containing power supply, a flexible arm and a light emitting head containing (162 blue 470 nm, 180 red 645 nm and 126 infrared 850 nm). The user interface is accessed via Wi-Fi from any multimedia support with a browser. Elyx-PRO is provided with a main cable, a router, protective goggles and a user manual.

LED photomodulation principle is to use LEDs of specific wavelengths and to select accurate stimulation parameters (duration, distance, optical power...) to stimulate targeted biological mechanisms and obtain desired clinical effects.

The provided text does not contain any information about clinical studies that establish acceptance criteria or demonstrate device performance against such criteria for the eLyx-PRO device.

The document is a 510(k) Summary of Safety & Effectiveness, which focuses on demonstrating substantial equivalence to predicate devices, rather than presenting de novo clinical study results that would typically include acceptance criteria and performance metrics.

Specifically, the document states:

• "eLyx-PRO raises no new issues of safety or effectiveness and no significant differences exist compared to its predicate devices. Therefore, eLyx-PRO has been found to be substantially equivalent to previously cleared devices."
• Under "6. Substantial Equivalence," it compares features and intended uses to predicates, noting that the eLyx PRO's intended use is a "combination of the intended use of its predicates."
• "7. Performance data" lists various safety tests performed according to international standards (e.g., electrical, EMC, biocompatibility, photobiological safety, usability). These are engineering and safety benchmarks, not clinical performance metrics tied to acceptance criteria for the intended therapeutic effects (acne, wrinkles, pain relief).

Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text. The document relies on substantial equivalence and compliance with general safety standards, not on new clinical performance data establishing efficacy against predefined acceptance criteria.

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