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Red light: Treatment of full-face wrinkles.

Blue light: Treatment of mild to moderate inflammatory acne.

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. Mixed light: Treatment of mild to moderate inflammatory acne.

LED light therapy mask is a home use wearable LED phototherapy device which can help solve various skin problems. LED light therapy mask is consisting of mask, controller, adapter, USB cable and straps.

There are 4 kinds of light which include Red light (wavelength 620mm), Blue light (wavelength 460nm), Infrared light (wavelength 850mm), Mixed light (wavelength 620mm and 850nm and 460nm).

The provided text is a 510(k) Summary for a medical device (LED light therapy mask) seeking clearance from the U.S. FDA. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the document does not contain the specific information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment for a specific study conducted for this device.

Instead, the document primarily compares the subject device to several predicate devices across various characteristics and lists non-clinical tests conducted to ensure safety and compliance with relevant standards. It explicitly states, "Clinical data: Not applicable."

Here's a breakdown of what can be extracted or inferred based on your request, and what is not available in the provided text:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence through comparison to predicate devices and adherence to recognized standards, not on presenting specific performance criteria and results of a dedicated study for the current device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not available. The document explicitly states "Clinical data: Not applicable," meaning no clinical test set was used for this 510(k) submission to demonstrate the device's efficacy.

3. 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):

This information is not applicable/not provided. Since no clinical test set with human assessments or ground truth establishment relevant to efficacy is mentioned, there are no experts establishing ground truth in this context. The document focuses on regulatory compliance and technical equivalence.

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

This information is not applicable/not provided. Without a clinical test set requiring adjudication, this detail is irrelevant to this submission.

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:

This information is not applicable/not provided. The device is an LED light therapy mask, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable/not provided. This is a physical device (LED light therapy mask), not an algorithm or software-only device. Therefore, a standalone algorithm performance study is not relevant.

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

This information is not applicable/not provided. Since no clinical efficacy study or test set for the device's indications is presented, there is no discussion of the type of ground truth used to validate its performance for those indications. The "ground truth" in this context is the performance and safety established for the predicate devices and the compliance to international safety standards.

8. The sample size for the training set:

This information is not applicable/not provided. As "Clinical data: Not applicable" is stated, there is no mention of a training set for an algorithm.

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

This information is not applicable/not provided. No training set for an algorithm is mentioned.

Summary of available information related to the device's 'proof' and acceptance:

The 'proof' for the LED light therapy mask meeting the criteria for market clearance (not specific acceptance criteria against a clinical study) relies on demonstrating substantial equivalence (SE) to legally marketed predicate devices and compliance with recognized non-clinical safety standards.

Non-clinical tests performed (supporting safe operation, not efficacy for treatment claims):

• Electrical safety: ANSI AAMI ES 60601-1
• Electromagnetic compatibility: IEC 60601-1-2
• Home healthcare environment requirements: IEC 60601-1-11
• Safety of non-laser light source equipment: IEC 60601-2-57
• Biocompatibility:
  • ISO 10993-5 (In Vitro Cytotoxicity)
  • ISO 10993-10 (Irritation and Skin Sensitization)
• Software verification and validation testing: Conducted as per FDA's guidance for software in medical devices.

Conclusion stated in the document:

"The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that LED light therapy mask should perform as intended in the specified use conditions, and all the data demonstrate that the subject devices perform comparably to the predicate device that is currently marketed for the same intended use. In other words, the subject device (LED light therapy mask) is Substantial Equivalent to the predicate devices K200983, K221151, K162489 and K212155."

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