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The Sonilase™ Light Device Red is used to treat periorbital wrinkles and fine lines around the eyes (i.e., crow's feet).

The Sonilase Light Deviceis a modular system that offers red light therapy for the treatment of wrinkles, rhytides, and fine lines in the periorbital region. The Sonilase system components include the handheld unit containing the LED module , attachable clear plastic lens cover, an adjunct attachable cleansing brush head, recharging stand, 7.4V LI-ION BATTERY, 9V UL approved power supply , UV Sanitizing cradle and goggles. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).

Here's an analysis of the acceptance criteria and the study that "proves" the device meets them, based on the provided 510(k) summary for the Sonilase Light Device Red:

Important Note: This 510(k) summary is for a light-based over-the-counter wrinkle reduction device. The "acceptance criteria" and "study" described are in the context of demonstrating substantial equivalence to a predicate device, not necessarily a rigorous clinical trial proving independent efficacy as might be seen for a novel therapeutic device. The focus here is on showing similar performance to a device already deemed safe and effective.

Acceptance Criteria and Reported Device Performance

This section is challenging to populate directly from the provided text because explicit "acceptance criteria" as pass/fail thresholds for clinical efficacy are not clearly defined or presented for this specific device. Instead, the submission relies on demonstrating technological equivalence and similar performance characteristics to a legally marketed predicate device (Tanda Max OTC System).

The "performance" described is largely focused on confirming the device operates as intended and is safe for use by laypeople, rather than clinical outcomes.

Study Information

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

   • Test Set Sample Size: 38 participants for the Usability/Label Comprehension Study.
   • Data Provenance: Not explicitly stated, but typically these studies are conducted in the country of submission (USA for FDA). The study is prospective in nature, as it involves active participation and observation.

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

   • This question is not directly applicable in the context of this 510(k) submission as no "ground truth" derived from expert assessment of patient outcomes for wrinkle reduction efficacy is presented or required for this type of device and submission pathway. The Usability study focuses on user comprehension and device operation, not clinical ground truth.

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

   • Not applicable. The usability study involved observing participants and assessing their comprehension of labeling and ability to use the device, not adjudicating clinical observations.

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. This is not an AI-assisted device, nor is it a diagnostic imaging device where MRMC studies are typically performed.

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

   • Not applicable. This is a physical light therapy device, not an algorithm. Its performance is inherent in its physical properties and intended use.

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

   • For the usability study, the "ground truth" was established by observing whether participants successfully comprehended instructions and operated the device as intended. This is a form of empirical observation of user behavior against predefined success criteria for usability and comprehension.
   • For the overall substantial equivalence, the "ground truth" for efficacy is implicitly the established efficacy of the predicate device (Tanda Max OTC System) for wrinkle reduction. The Sonilase device is deemed substantially equivalent because it shares the same technological characteristics (wavelength, power, treatment regimen) and intended use as the predicate.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the machine learning sense. The device's design, functional testing, and usability study are based on engineering principles and human factors, not data training.

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

   • Not applicable, as there is no "training set."

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