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• Red+Infrared light: Treatment of full-face wrinkles.
• Red light: Treatment of full-face wrinkles.
• Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
• Blue light: Treatment of mild to moderate inflammatory acne.
• Red+Blue light: Treatment of mild to moderate inflammatory acne.
  The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.

The LED Light Therapy Mask adopts light emitting diodes (LED) in the infrared, red and blue spectrum to irradiate on the skin. The face will absorb the light energy to achieve the effects. The LED Light Therapy Mask is applied directly to the skin to ensure consistent administration of light during each treatment. LED Light Therapy Mask is a home use wearable LED phototherapy device which can help reduce wrinkles and arovide topical heating, It is consisting of main unit(mask), controller, Type-C charging cable and so on.
The RB-081 outputs 5 kinds of treatment modes: red infrared, blue, red+blue light. The RB-030 outputs 4 kinds of treatment modes: red-infrared, red, infrared, blue light. The RB-008 outputs 3 kinds of treatment modes: red+infrared, red, blue light. The RB-008G/ RB-008GB/RB-008J/RB-008JB output 4 kinds of treatment modes: red+infrared, red, blue light.

The provided document is a 510(k) summary for an LED Light Therapy Mask. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety standards. It does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of clinical performance.

The document details non-clinical tests conducted to verify design specifications and compliance with safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11). However, it lacks clinical performance data or studies against specific acceptance criteria for its intended use (treatment of wrinkles and acne).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, as this information is not present in the given text.

Here's a breakdown of why I cannot answer each point:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on technical specifications and safety compliance, not clinical performance metrics against acceptance criteria.
2. Sample size used for the test set and the data provenance: Not provided. No clinical test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No clinical ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided. No clinical test set or adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a light therapy mask, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a light therapy mask, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided. No clinical ground truth is mentioned.
8. The sample size for the training set: Not provided. No training set for clinical performance is mentioned.
9. How the ground truth for the training set was established: Not provided. No ground truth for a training set is mentioned.

The document states: "Non-clinical tests have been conducted to verify that the Light Therapy Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate devices. The testing results device complies with the following standards: IEC 60601-1:2020, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2:2021, Medical electrical equipments for basic safety and essential performance -Collateral standard: Electromagnetic disturbances - Requirements and tests, IEC 60601-1-11:2020, Medical electrical equipments for basic safety and essential performance --." This indicates that the "acceptance criteria" for this submission were primarily focused on safety, electromagnetic compatibility, and general performance standards, rather than direct clinical efficacy trials. The claim of substantial equivalence (SE) is based on these non-clinical tests and technological comparison to predicate devices, not on specific clinical acceptance criteria for wrinkle or acne reduction.

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