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The LightStim Professional System #3A panel is intended for the treatment of full-face wrinkles.

The LightStim Professional System #3B panel is intended for the treatment of mild to moderate acne.

The LightStim Professional System #4 panel is intended for the treatment of mild to moderate acne.

The LightStim Professional 2-Panel Light System is a portable device that has two (2) separate interchangeable 2-panel treatment heads, each containing 1.130 LEDs. Each treatment heads is attached to a fully retractable and articulating arm with a 42" reach. Either one of these arms can be attached to the rolling stand for use. There is an on/off switch, and an AC to DC power supply.

The LightStim 2-Panel Light System is intended to be operated only by a person who has been personally trained by Company personnel. Each device includes a detailed Instruction Manual and includes one-on-one training and instruction by Company training staff. That training includes a thorough review of the Instruction Manual for the device and actual one-on-one training on the operation of the device with the end user.

This document describes the LightStim Professional 2-Panel Light System, a device for treating facial wrinkles and acne. However, it does not contain the specific information required to complete your request about acceptance criteria and a study proving the device meets those criteria. The provided text is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance study results against specific acceptance criteria.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily focuses on regulatory approval by demonstrating substantial equivalence to previously cleared devices. It states that "the LightStim Professional 2-Panel Light System raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate devices."

The 'Performance Testing' section only mentions conformance to general electrical and electromagnetic compatibility standards (IEC/EN 60601-1 and IEC/EN 60601-1-2) which are related to device safety and essential performance, not clinical effectiveness or specific acceptance criteria for treating wrinkles or acne. No clinical study data or performance metrics against specific efficacy endpoints are provided in this document.

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