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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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LED Facial 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 Facial Mask is an over-the-counter, facemask-shaped design light emitting diode (LED) device that emits light energy in the red, blue, and amber spectrum for the treatment of wrinkles or mild to moderate inflammatory acne on the face. The device consists of a mask body unit, controller, and AC adapter. The mask body unit contains light emitting diodes (LEDs) that emit visible red light (650nm+/-5nm), amber light (605nm+/-5nm), or blue light (465nm+/-5nm) to help reduce the appearance of wrinkles or mild to moderate acne. A controller is connected to the mask body unit to control the device, such as turn on/off the device, switch LED color output. An AC adapter is used to power the device. To use the device, user should place the mask body unit over the face and use the controller to operate. The device will automatically turn off after each treatment.

The LED Facial Mask includes MZ-01, NEWKEY-01, and SP-FM-01 models. Their intended use, performance, structure design, and operation are identical, with the difference being the product appearance, but these differences do not affect or change the intended use of the device.

The provided text is a 510(k) summary for an LED Facial Mask, a medical device for over-the-counter use in treating wrinkles and mild to moderate acne. However, it does not contain information about studies that prove the device meets acceptance criteria related to its clinical efficacy.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through technical specifications, safety data (biocompatibility, electrical safety, eye safety), and software verification and validation. There's no mention of clinical trials or performance studies evaluating the device's effectiveness in treating wrinkles or acne in accordance with specific acceptance criteria beyond general safety and design similarity to other cleared devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving the device meets them for its intended clinical effects because such information is not present in the provided text. The document primarily details technical and safety compliance, not clinical performance metrics.

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SYNERGY MARBLE is a hand-held device for over-the counter aesthetic purposes. The device red light and amber light are intended for the use in treating wrinkles on the face, and the blue light is intended for the treatment of the mild to moderate inflammatory acne.

The SYNERGY MARBLE is an over-the-counter, battery powered hand-held light emitting diode (LED) device that emits light energy in the red, blue and amber spectrum for the treatment of wrinkles or mild to moderate inflammatory acne on the face. The SYNERGY MARBLE components include an applicator, a charging station and an adaptor. The treatment surface is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user repairable components. The device is sold as Over the Counter (OTC).

The provided 510(k) summary for the SYNERGY MARBLE (Model: Opasm) device does NOT include a robust clinical study or performance-based acceptance criteria for its intended uses (treating wrinkles and mild to moderate inflammatory acne).

Instead, the submission relies on non-clinical testing and a demonstration of substantial equivalence to previously cleared predicate devices. Therefore, a table of acceptance criteria and reported device performance with associated study details cannot be fully constructed as requested.

However, based on the information provided, we can infer some "acceptance criteria" through the lens of substantial equivalence and present the non-clinical testing conducted.

Inferred Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence and Non-Clinical Testing)

Study Details (Based on the provided 510(k) Summary)

The provided document describes non-clinical testing for safety and performance related to electrical safety, EMC, usability, photobiological safety, battery safety, and biocompatibility. It does NOT describe a clinical study to directly prove the device meets acceptance criteria for its intended therapeutic effects (treating wrinkles or acne).

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

   • Test Set Sample Size: Not applicable. The document refers to non-clinical bench testing and conformity to international consensus standards, rather than a test set of patient data.
   • Data Provenance: The data provenance is from laboratory bench testing (non-clinical) and conformity assessments against international standards. No specific country of origin is mentioned for these lab tests, but the manufacturer is YRS Group Inc. (US) and the consultant is from Shanghai, China.

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

   • Not applicable. As this was non-clinical testing against established standards, there was no "ground truth" established by experts in a clinical context. Results were compared against the requirements of the standards themselves.

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

   • Not applicable. There was no clinical test set requiring adjudication.

4. 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 MRMC comparative effectiveness study was done. This device is a light-based therapy device, not an AI-assisted diagnostic or therapeutic device requiring human reader assessment.

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

   • Not applicable. This device is a direct-use therapy device, not an algorithm.

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

   • For the non-clinical testing, the "ground truth" was defined by the specific requirements and limits set forth in the international consensus standards (e.g., maximum current leakage for electrical safety, specific wavelengths and energy densities, cytotoxicity limits). There was no clinical ground truth established for effectiveness.

7. The sample size for the training set:

   • Not applicable. This review concerns non-clinical testing and substantial equivalence, not a machine learning model that requires a training set.

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

   • Not applicable.

Conclusion from document:

The SYNERGY MARBLE device gained clearance by demonstrating substantial equivalence to existing legally marketed predicate devices (K202055 - Looper and K190443 - MMSphere™) through a comparison of technological characteristics and intended uses, alongside conformity to relevant non-clinical safety (electrical, EMC, photobiological, battery, usability, home use) and biocompatibility standards. The submission explicitly states: "The conclusion drawn from the non-clinical tests is that the device is as safe, as effective, and performs as well as the legally marketed predicate device K202055 and reference device K190443." This implies that clinical effectiveness for wrinkle reduction and acne treatment is primarily supported by the established effectiveness of the predicate devices, rather than a new clinical study.

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The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne.

The Beauty LED Mask adopts light emitting diodes (LED) in the red (637nm ± 5nm) + infrared (854nm ± 5nm) and blue (465 ± 5nm) spectrum to irradiate on the face to realize its therapeutic effect. The Beauty LED Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). Power adapter is provided to charge the battery contained in the controller. 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, Beauty LED Mask has incorporated protective eye-shield which blocks light energy from LEDs.

The provided document is a 510(k) summary for the Beauty LED Mask, Model: KFB265. It outlines the device's characteristics and its substantial equivalence to a predicate device, but it does not contain information about clinical studies or specific acceptance criteria and performance data related to its effectiveness in treating wrinkles and acne.

The document primarily focuses on:

• Regulatory classification and product codes.
• Comparison of technological characteristics with predicate devices (e.g., light source, wavelength, power supply, dimensions).
• Compliance with non-clinical standards, such as electrical safety (IEC 60601 series, IEC 62133-2), photobiological safety (IEC 62471), and biocompatibility (ISO 10993 series).
• Software verification and validation.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for clinical outcomes.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for the test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used (clinical outcomes, pathology, etc.).
• Sample size and ground truth establishment for a training set.

The document states that "Non-clinical testings have been conducted to verify that the Beauty LED Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device." This indicates that the 510(k) clearance was based on demonstrating equivalence in non-clinical technical characteristics and safety, rather than requiring new clinical performance data for effectiveness.

In summary, the provided text describes a regulatory submission based on substantial equivalence to a predicate device through non-clinical testing, not a study proving clinical effectiveness against specific acceptance criteria.

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