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The Sonilase Blue is a hand held OTC device intended to emit energy in the light spectrum for use in the treatment of mild to moderate acne vulgaris.

The Sonilase Blue-UV Clean is a hand held OTC device intended to emit energy in the light spectrum for use in the treatment of mild to moderate acne vulgaris.

The Sonilase Blue-UV Clean Plus is a hand held OTC device intended to emit energy in the blue region of the light spectrum for use in the treatment of mild to moderate acne vulgaris.

The Sonilase Blue, Sonilase Blue-Clean, and Sonilase Blue-UV Clean Plus are modular system devices that offer blue light therapy for the treatment of mild to moderate acne vulgaris.

The Sonilase Blue device components include the handheld unit containing the LED module with 3 (415nm) LEDs . attachable clear plastic lens cover. an adjunct attachable cleansing brush head, recharging stand, 7.4 v LI-ION BATTERY, 9V UL approved power supply and goggles.

The Sonilase Blue-Clean device components include the handheld unit containing the LED module with 3 blue LEDs (415nm) attachable opaque lens cover, an adjunct attachable cleansing brush head. recharging stand. 7.4 v LI-ION BATTERY. 9V UL approved power supply and goggles.

The Sonilase Blue-UV Clean Plus device components include the handheld unit containing the LED module with 3 blue LEDs (415nm) and 3 UV sanitizing LEDs , attachable opaque lens cover, a detachable cleansing brush head, recharging stand, 7.4 v LI-ION BATTERY, 9V UL approved power supply and goggles.

The Sonilase Blue, Sonilase Blue-UV Clean, and Sonilase Blue-UV Clean Plus devices operate by a cordless system drawing upon their 7.4V rechargeable LI-ION battery to deliver the treatment.

The Sonilase Blue. Sonilase Blue-Clean, and Sonilase Blue-UV Clean Plus utilize blue light at 415 nm +/- 5nm.

The Sonilase Blue is applied directly to the skin to ensure consistent administration of light during each treatment.

The Sonilase Blue-Clean and Sonilase Blue-UV Clean Plus are applied to the skin with the cleansing brush still attached, but the amount of treatment energy (Dose) delivered to the skin is the same.

The Sonilase Blue, Sonilase Blue-Clean, and Sonilase Blue-UV Clean Plus have a skin sensor that will not allow the device to illuminate unless it is in contact with the skin as a safety feature.

The Sonilase Blue, Sonilase Blue- Clean, and Sonilase Blue-UV Clean Plus devices do not contain any user serviceable components. The devices are sold as Over the Counter (OTC).

The provided document is a 510(k) premarket notification for three medical devices: Sonilase Blue, Sonilase Blue-Clean, and Sonilase UV-Clean Plus. These devices are intended for the treatment of mild to moderate acne vulgaris. The document demonstrates substantial equivalence to predicate devices, primarily K121435 - Silk'n Blue and K124042 - Tanda Mini Skincare System.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Sonilase Blue series of devices are implicitly defined by their substantial equivalence to the predicate devices and their compliance with relevant international consensus standards. The performance reported focuses on meeting these technical specifications and demonstrating user safety and comprehension.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Usability/Label Comprehension Study: 39 participants.
• Data Provenance: The document does not specify the country of origin or whether the study was retrospective or prospective for the usability study. It is implied to be a prospective usability study since participants "were able to comprehend the labeling" and "use the device successfully."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish 'ground truth' in the context of acne treatment efficacy. The studies described are centered around engineering performance, electrical safety, EMC, and user comprehension/usability for an OTC device. For the usability/label comprehension study, there were no "experts" establishing ground truth in the clinical sense; rather, the participants themselves provided the data on comprehension and usage success.

4. Adjudication Method for the Test Set

Not applicable in the context of the reported studies. The usability/label comprehension study involved direct observation and assessment of participant interaction, not a multi-reader review process.

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. The device is a blue light therapy device for acne, not an AI-powered diagnostic or interpretive tool that would involve human "readers" or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a physical light therapy device, not an algorithm. Its performance is inherent in its physical and electrical characteristics and ability to deliver blue light.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the engineering and safety tests, the "ground truth" is defined by the objective standards themselves (e.g., IEC standards). For the usability/label comprehension study, the "ground truth" was established by the participants' direct experience and performance (comprehension and successful usage). There is no mention of clinical efficacy studies or ground truth related to clinical outcomes like pathology or expert consensus on acne improvement in this 510(k) summary, as it relies on substantial equivalence to existing devices for clinical claims.

8. The Sample Size for the Training Set

Not applicable. The reported studies (electrical safety, performance, EMC, software validation, usability) do not involve machine learning algorithms requiring training sets.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm.

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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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