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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 SYNERGY is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.

The SYNERGY is an over-the-counter, battery powered, hand-held light emitting diode (LED) device that emits light energy in the red and infrared spectrum for the treatment of wrinkles on the face. The SYNERGY 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 for Over the Counter (OTC) use.

The provided text is a 510(k) summary for the "SYNERGY" device, a red/IR light therapy device intended for treating facial wrinkles. It establishes substantial equivalence to a predicate device, "Elevare Plus" (K172909).

However, the provided document does not contain any information about acceptance criteria for device performance related to efficacy (e.g., wrinkle reduction) or any study that proves the device meets such criteria (e.g., a clinical study with human subjects). It focuses primarily on the safety and technological equivalence to a predicate device.

The document details non-clinical testing for electrical safety, EMC, photobiological safety, battery safety, and biocompatibility, as well as software validation and skin temperature testing. These tests ensure the device is safe to use and performs within its design specifications, but they do not address the clinical effectiveness of wrinkle reduction or any acceptance criteria for that purpose.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance

   • The document does not provide acceptance criteria for clinical efficacy (e.g., quantitative wrinkle reduction) or corresponding performance data. The "performance testing" mentioned refers to software validation and skin temperature, not clinical outcomes.

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

   • No human test set for clinical performance is described. The "test set" for non-clinical testing (e.g., electrical safety, temperature) would refer to the device units tested, not human subjects.

3. Number of experts used to establish the ground truth

   • Not applicable, as no clinical efficacy study or ground truth establishment for clinical outcomes is described.

4. Adjudication method

   • Not applicable.

5. MRMC comparative effectiveness study

   • Not applicable.

6. Standalone performance

   • Not explicitly described in terms of clinical efficacy. The standalone performance testing mentioned is for device safety and functional specifications (e.g., skin temperature).

7. Type of ground truth used

   • Not applicable for clinical ground truth. For the safety tests, the "ground truth" would be established by the standards themselves (e.g., IEC 60601-1, IEC 62471).

8. Sample size for the training set

   • Not applicable, as this is a physical device, not an AI/ML algorithm that requires a training set of data for clinical performance.

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

   • Not applicable.

Summary of Information Available Related to Safety and Technical Performance:

The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and safety standards.

• Acceptance Criteria (Safety/Technical Performance): The device conforms to several international consensus standards for electrical safety (ANSI AAMI ES60601-1, ANSI AAMI IEC 60601-1-2, ANSI AAMI IEC60601-1-11), photobiological safety (IEC 62471), battery safety (IEC 62133-2), and biocompatibility (ISO 10993-5, ISO 10993-10). Additionally, skin temperature testing ensured the device stayed within 41 ± 2℃ and did not elevate skin temperature above 43°C. Software validation was conducted per FDA guidance.
• Study Proving Acceptance Criteria (Safety/Technical Performance):
  • The document states that "The SYNERGY has been tested and conforms to international consensus standards" and lists the specific standards.
  • For skin temperature, it states "The test results concluded that the SYNERGY was within specification of 41± 2℃ and did not elevate skin temperature above 43°C."
• Sample size and data provenance for these technical tests: Not specified beyond the implication that device units were tested in a non-clinical setting. The data provenance would be from laboratory testing.
• Experts/Ground truth for technical tests: Ground truth is established by the specified international consensus standards for device safety and performance. No "experts" in the sense of clinical reviewers are mentioned for these technical tests; rather, certified testing laboratories and their protocols would be involved.
• MRMC/Standalone (clinical efficacy): Not relevant or discussed in this document.

In conclusion, the provided FDA 510(k) summary addresses the safety and technical specifications of the SYNERGY device, demonstrating its substantial equivalence to a predicate device. It does not include information on clinical efficacy studies or acceptance criteria related to the device's intended effect on wrinkles.

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