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• Mode 1 (Red + Infrared light): treatment of full face wrinkles.
• Mode 2 (Blue light): Treatment of mild to moderate inflammatory acne.
• Mode 3 (Mixed light): Treatment of mild to moderate inflammatory acne.

LED phototherapy masks are over-the-counter light-emitting diode (LED) devices that emit energy and are used in dermatology to treat acne and wrinkles. The device emits red (630nm) and infrared (850nm) light to treat wrinkles and blue (415nm) light to treat mild to moderate acne. All models had to be fitted with an eye mask and strapped to the treatment area, and all had a controller to set the parameters of the device. There are 10 models of the device (model: E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A), all of which are operated through a controller.

The provided text describes an FDA 510(k) premarket notification for an "LED light therapy mask." This document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than clinical performance studies.

Therefore, the information required to answer your request regarding acceptance criteria and performance based on clinical studies is largely not present in the provided text. The document explicitly states:

"8.2 Summary of Clinical Performance: Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

This means there was no multi-reader, multi-case study, no standalone algorithm performance, no detailed ground truth establishment, and no sample sizes for test or training sets from clinical data because a clinical study was not performed or required for this submission.

However, I can extract the information related to the non-clinical tests performed and common regulatory standards:

Summary of Information from the Provided Document:

1. A table of acceptance criteria and the reported device performance:

• Clinical Performance: Not applicable/not performed for this 510(k) submission.
• Non-Clinical Performance (Acceptance Criteria are inferred by compliance with standards):

2. Sample size used for the test set and the data provenance:

• Clinical Test Set: Not applicable, no clinical test set was used/required.
• Non-Clinical/Engineering Tests: Sample sizes for hardware, software, and biocompatibility testing are not specified in this summary, which is typical for 510(k) summaries of this nature (they primarily list the standards complied with). Data provenance for these tests would typically be from the manufacturer's internal testing or third-party accredited labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable, as no clinical test set requiring expert ground truth establishment was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable, as no clinical test set requiring adjudication was used.

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:

• No, a MRMC study was not done. The device is an LED light therapy mask, not an AI diagnostic assistant 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 direct treatment device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable for clinical ground truth. For non-clinical tests, "ground truth" would be the specifications and requirements defined by the relevant engineering and safety standards (e.g., specific wavelength output, power intensity, safety thresholds for electrical current, absence of cytotoxic effects, etc.).

8. The sample size for the training set:

• Not applicable, as no clinical training set was used for an AI algorithm.

9. How the ground truth for the training set was established:

• Not applicable.

In summary, this FDA 510(k) submission for the LED light therapy mask relied on non-clinical performance data and compliance with recognized consensus standards to demonstrate substantial equivalence, rather than new clinical trials or studies involving human "readers" or AI performance evaluation.

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