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The Solawave 2-in-1 Skincare Mini (Model: 61043) is an over-the-counter device that emits energy in the red and infrared spectrum for treating wrinkles on the face and decolletage.

The Solawave 2-in-1 Skincare Mini (Model: 61043) is a hand-held, battery-powered device that reduce wrinkles by emitting LED red light (630nm) and infrared light (830nm). The device is powered by a Lithium-Ion rechargeable battery, and it comes with a charging cable, storage bag, and instruction manual.

The Solawave 2-in-1 Skincare Mini is a revolutionary device that offers two simultaneous approaches for your skin routine in one handheld device:

1. Red and Near-Infrared Light Therapy
2. Warming function (This function is not for medical purpose)

The provided FDA 510(k) clearance letter for the Solawave 2-in-1 Skincare Mini (K250532) indicates that no clinical performance studies were conducted or deemed necessary for its clearance.

Therefore, it is not possible to describe acceptance criteria and associated study results for device performance based on the provided document, as no such studies were submitted or reviewed by the FDA for this particular clearance.

The document states:

• "Clinical testing was not needed for this 510(k)." (Page 10, Section 7.2)
• The clearance is based on the device being "substantially equivalent" to legally marketed predicate devices. This means the FDA determined the device has the same intended use and technological characteristics as a predicate device, or if there are differences, those differences do not raise different questions of safety and effectiveness.

Breakdown of the requested information based on the provided document:

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

   • Not applicable. No clinical performance studies were conducted or provided in this 510(k) submission to establish acceptance criteria for device performance or report device performance against such criteria. The "performance" assessment was primarily through comparison to predicate devices and non-clinical testing.

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

   • Not applicable. No clinical test set was used for performance evaluation in this 510(k).

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. No clinical test set requiring expert ground truth was used for performance evaluation in this 510(k).

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

   • Not applicable. No clinical test set requiring adjudication was used for performance evaluation in this 510(k).

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-based therapy device, not an AI-powered diagnostic or assistive tool, and no MRMC study was conducted.

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

   • Not applicable. This device is a physical light-based therapy device, not an algorithm, and no standalone performance study was conducted.

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

   • Not applicable. No clinical ground truth was established as no clinical studies were performed. The "ground truth" for substantial equivalence was based on existing predicate device characteristics and regulatory standards.

8. The sample size for the training set:

   • Not applicable. This device is a physical light-based therapy device, not a machine learning model, and therefore does not have a "training set" in the context of AI/ML.

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

   • Not applicable. As above, no training set for an AI/ML model was used.

Summary of what was reported instead:

The 510(k) submission relied on:

• Non-Clinical Tests:
  • Electrical safety (e.g., IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-1-2)
  • Photobiological safety (IEC 62471)
  • Battery safety (IEC 62133-2)
  • Biocompatibility (ISO 10993-5, ISO 10993-10, ISO 10993-23)
  • Software verification and validation (classified as "moderate" concern)
• Comparison to Predicate Devices: The document extensively compares the Solawave 2-in-1 Skincare Mini with several predicate and reference devices regarding features like intended use, regulation class, product code, power source, irradiance source, wavelengths, irradiances, and treatment time to establish substantial equivalence. The argument for equivalent "treatment effect (wrinkle treatment)" is made based on similar wavelengths, and irradiances/treatment times being "very close to those of reference devices 1 and 2."

In conclusion, for this specific 510(k), the acceptance criteria and proof of device performance were primarily established through substantial equivalence to existing legally marketed devices and successful completion of non-clinical safety testing, rather than through new clinical performance studies.

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