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The VersaClear™ Skin Therapy System UVA (350mm) Light Module is indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.

The VersaClear™ Skin Therapy System UVA (350mm) Light Module is a 120/240V 50/60 Hz AC illumination source that emits UVA radiation with a peak at 350mm ± S mm.

The provided document is a 510(k) summary for the TheraLight VersaClear™ Skin Therapy System UVA (350nm) Light Module. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics for a new device's efficacy or diagnostic accuracy.

Therefore, many of the requested details about acceptance criteria, study design for proving those criteria, sample sizes, expert involvement, and ground truth establishment are not typically found in a 510(k) summary for a device like this. This document primarily focuses on technical specifications and comparison to an existing device.

Here's an analysis based on the information available in the provided text:

1. Table of acceptance criteria and the reported device performance:

Explanation: The document does not explicitly state "acceptance criteria" for a clinical study to prove the device's efficacy. Instead, the "Performance Data" section describes the technical specifications of the device. The implicit acceptance criteria are that these specifications should be substantially equivalent to the predicate device (Flex Controlled Phototherapy Equipment, K050695) for the purpose of treating dermatologic/skin disorders. The "Conclusion" explicitly states that the device "is substantially equivalent to legally commercialized UV phototherapy devices."

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

• Sample Size: Not applicable. The document describes a technical characterization of the device's light output, not a clinical study involving human or even in vitro test subjects to evaluate performance against a "test set" in the context of diagnostic or treatment accuracy.
• Data Provenance: The data provided pertains to the physical characteristics of the device itself (light emission properties). It is not clinical data from patients or a specific country of origin.

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

• Number of Experts: Not applicable. No clinical ground truth or expert consensus was required for the technical specifications of light output.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Not applicable. There was no "test set" requiring adjudication in the context of clinical outcomes or expert review.

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-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness assessment was performed or reported.

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

• Not applicable. This is not an algorithm-based device. "Standalone performance" in this context refers to the device's ability to emit light with specified characteristics, which is described directly.

7. The type of ground truth used:

• In the context of the device's performance data (light emission): The "ground truth" is the physical measurement of the device's light output (e.g., peak wavelength, bandwidth, irradiance) using appropriate radiometric equipment.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML device that requires a "training set."

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

• Not applicable. (See #8)

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The VersaClear Skin Therapy System is generally indicated to treat dermatological conditions. Blue light modules are indicated to treat moderate inflammatory acne vulgaris. Red light modules are indicated for use in combination with blue light for the treatment of moderate inflammatory acne vulgaris, and for use alone in the treatment of superficial, benign vascular, and pigmented lesions. UVA light modules are indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.

The VersaClear™ Skin Therapy System is a 120/240V 50/60 Hz AC illumination source consisting of one or more light modules. A set of light modules emits a specific narrow spectrum of light, namely blue (420 ± 2nm), red (615 ± 3nm), or UVA (368 ± 3nm). The light modules are mounted on a positioning arm attached to a mobile or stationary pedestal, a wall, or a countertop. This flexible design accommodates varying office spatial settings, and allows for the treatment of patients who are sitting, reclining, or lying down. Light modules are interchangeable to maximize System versatility.

The document provided is a 510(k) summary for the VersaClear™ Skin Therapy System. It states that the device is substantially equivalent to predicate devices based on its performance characteristics and that there are no new safety or efficacy issues. However, it does not include a detailed study or specific acceptance criteria with reported performance data for the VersaClear™ Skin Therapy System itself.

Instead, the submission relies on the concept of "substantial equivalence" to predicate devices. This means that the FDA determined the new device is as safe and effective as a legally marketed device that was already on the market before May 28, 1976 (preamendments device) or to a device that has been reclassified.

Therefore, many of the requested details about a specific study and its acceptance criteria are not present in this document.

Here's what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds in this document for the VersaClear™ System. The implicit "acceptance criterion" is proving substantial equivalence to predicate devices, meaning the performance characteristics are similar enough not to raise new safety/efficacy concerns.
• Reported Device Performance: The document states, "The performance characteristics of the VersaClear System are substantially similar to the cited predicate devices. The technological differences do not raise new types of safety or efficacy issues." No specific quantitative performance data for the VersaClear™ System is provided.

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

• Not provided. The document does not describe a new study with a test set for the VersaClear™ System. It relies on the performance of predicate devices.

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/Not provided. No new test set data is discussed.

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

• Not applicable/Not provided. No new test set data is discussed.

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-driven image analysis or diagnostic tool involving human readers.

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.

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

• Not applicable/Not provided. No new study data is discussed. The "ground truth" for the substantial equivalence claim relies on the established safety and efficacy of the predicate devices for their respective indications.

8. The sample size for the training set:

• Not applicable/Not provided. This is not an AI/machine learning device.

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

• Not applicable/Not provided. This is not an AI/machine learning device.

Summary based on the provided text:

Conclusion from document:

The VersaClear™ Skin Therapy System received 510(k) clearance based on its substantial equivalence to previously cleared predicate devices. The submission affirms that the performance characteristics are "substantially similar" and "technological differences do not raise new types of safety or efficacy issues," thus eliminating the need for a de novo performance study with specific acceptance criteria in this submission.

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