(16 days)
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:
| Acceptance Criteria (Implicit from Predicate) | Reported Device Performance (VersaClear™ Skin Therapy System UVA (350nm) Light Module) |
|---|---|
| Emission of UVA radiation | Emits UVA radiation |
| Peak wavelength at 350nm ± 5mm | Peak at 350nm ± 5mm |
| Bandwidth (Full Width at Half Maximum) comparable to predicate | Bandwidth (Full Width at Half Maximum) of 40nm |
| Nominal skin irradiance comparable to predicate | Nominal skin irradiance of 10-35 mW/cm² |
| Intended for ultraviolet radiation therapy for diagnosed skin disorders | Indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders |
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)
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.