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LED Light Therapy Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.

The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (620mm±10mm), blue (460±10nm) and infrared (850nm=10nm) spectrum to irradiate on the face to realize its therapeutic effect. The LED Light Therapy Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller (Only for SKB-2318L,SKB-2318PRO, IN-FM002,SKB-2418) is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, LED Light Therapy Mask has incorporated protective eye-shield which blocks light energy from LEDs.

The provided document describes the substantial equivalence of the "LED Light Therapy Mask" to predicate devices, referencing several non-clinical tests. However, it does not contain information about acceptance criteria or a "study that proves the device meets the acceptance criteria" in the context of clinical performance data, particularly for the treatment of wrinkles and mild to moderate acne.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
• Adjudication method (e.g., 2+1, 3+1, none) for the test set
• 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
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on non-clinical aspects related to safety and general functionality, such as electrical safety, EMC, eye safety, and biocompatibility, to demonstrate substantial equivalence to previously cleared devices. It states: "Performance data supports that the device is safe predicate device and reference devices for its intended use," but does not detail what "performance data" was used to support efficacy claims for wrinkles and acne treatment.

The only "non-clinical studies and tests performed" explicitly mentioned are:

1. Electrical Safety and EMC (Standards: ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 62133-2)
2. Eye Safety (Standard: IEC 62471 Photobiological safety of lamps and lamp systems)
3. Biocompatibility Testing (Standards: ISO 10993-5, ISO 10993-10, ISO 10993-23)
4. Software verification and validation test (According to FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices")

These tests are primarily for device safety and regulatory compliance, not for assessing the clinical efficacy of the LED Light Therapy Mask's stated indications for use (treatment of wrinkles and mild to moderate acne). For a device making therapeutic claims, clinical performance data would typically be required to demonstrate effectiveness. Based on the provided text, this information is not available.

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