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• Blue light: Treatment of mild to moderate inflammatory acne.
• Red+IR light: Treatment of facial wrinkles.
• Amber light: Treatment of facial wrinkles.
• Mixed light: Treatment of mild to moderate inflammatory acne.

The Light Therapy System is an Over-the-Counter (OTC), home-use, wearable light based device, and intended for the use in treating full-face wrinkles and mild to moderate inflammatory acne. Light radiates from the inner surface of the device onto the face. This light is generated by LED with four different spectrum wavelengths: blue (460nm), amber (605nm), red (630nm) and infrared (850nm), and the device has four light treatment, that is, blue light and mixed light mode to treat acne, while amber light mode and red+ IR mode to treat facial wrinkles.

The device is powered by external power supply by connecting with the power adapter and controlled by the controller that should be connected to the main unit. The device's power-on/off, mode switch and treatment time adjustment can be operated by the controller. The device will automatically shut down when the treatment time is over.

The provided FDA 510(k) Clearance Letter for the "Light Therapy System (M500, L6)" does not contain information regarding a clinical study or performance data that would typically include acceptance criteria for clinical effectiveness.

The document focuses heavily on non-clinical testing for safety and electrical performance, and a comparison of technological characteristics with predicate devices to establish substantial equivalence.

Therefore, based solely on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner requested (clinical effectiveness).

The "Conclusions" section on page 12 states: "Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device Light Therapy System is as safe, as effective, and performs as well as the legally marketed predicate devices."

This statement regarding "effectiveness" is likely based on the technological characteristics comparison with predicate devices (Section VI) rather than a direct clinical performance study of the subject device. The clearance is based on substantial equivalence to predicate devices that have established clinical effectiveness, and the assumption is that similar technological characteristics (wavelengths, intensities, treatment times for similar indications) will yield similar clinical outcomes.

If information about clinical performance and acceptance criteria were present, it would typically be found under a "Clinical Testing" or "Performance Data" section that is absent in this excerpt for clinical efficacy.

To answer your specific points based on the absence of clinical study details in this document:

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

• Cannot be provided from the given document for clinical performance. The document lists non-clinical performance (biocompatibility, electrical safety, EMC, software validation) and states they "passed," implying acceptance criteria were met for these aspects, but no specific metrics are given beyond "passed."

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

• Not applicable for clinical performance based on this document. No clinical test set or data provenance is detailed.

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)

• Not applicable for clinical performance based on this document. No experts or ground truth establishment for a clinical test set are described.

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

• Not applicable for clinical performance based on this document. No adjudication method 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 system, not an AI-assisted diagnostic device, and no MRMC study is mentioned.

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

• Not applicable. This device is a light therapy system, not an algorithm. Its performance is inherent to its physical light emission.

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

• Not applicable for clinical performance based on this document. For the non-clinical tests, the ground truth is derived from the "passed" status against established engineering and biological safety standards (e.g., IEC standards, ISO standards).

8. The sample size for the training set

• Not applicable for clinical performance based on this document. This applies to machine learning models, not a light therapy device's direct clinical performance study for a 510(k) substantial equivalence.

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

• Not applicable for clinical performance based on this document. (See point 8).

Summary of what the document does provide regarding "acceptance criteria" and "study":

The "study" in this context refers to non-clinical testing and comparison to predicate devices to demonstrate safety and substantial equivalence.

Acceptance Criteria & Reported Performance (Non-Clinical):

Data Provenance (Non-Clinical):

• These tests are typically conducted by the manufacturer or third-party labs on prototypes/production samples. The country of origin for these tests is not specified in the document, but the manufacturer is based in China. This is "prospective" in the sense that the tests were performed on the device intended for clearance.

Type of Ground Truth (Non-Clinical):

• The ground truth for non-clinical tests is established by international standards (ISO, IEC) and regulatory guidance documents (FDA recognized standards). Testing laboratories verify compliance with these predefined standards.

The clearance is based on the argument that the device's technological characteristics are substantially equivalent to legally marketed predicate devices, which themselves would have demonstrated efficacy through previous clinical data or established scientific principles. The non-clinical tests confirm the current device's safety and performance align with those precedents.

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