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The UV Biotek Mobile-Lite model 600 is for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)
The UV Biotek Versa-Lite model 1400 is for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)

The UV Biotek Mobile-Lite model 600 is a lightweight metal box containing six Philips 15-Watt TL-01 nUVB (narrowband UVB) lamps, configured as a suitcase for portability, designed to be placed either on a table or a stand for easy exposure to feet, lower legs, hands and lower arms. A remote control timer module is used to program exposure times and dosages.
The UV Biotek Versa-Lite model 1400 is a phototherapy device, freestanding support with 3 lighting panels containing a total of 14 Philips TL20W/01 (narrowband UVB) lamps. The panels can be used simultaneously or individually, depending on treatment needed. System dimensions: 83" high, 27" deep, and 28" wide - when system panels are in start position.

The described device, UV Biotek Mobile-Lite model 600 and UV Biotek Versa-Lite model 1400, did not undergo a study to demonstrate its performance against specific acceptance criteria. Instead, this 510(k) submission relies on demonstrating substantial equivalence to existing predicate devices.

Therefore, the typical structure for reporting acceptance criteria and study results (as outlined in your request) is not applicable in this case. The provided document is a 510(k) summary, which focuses on comparing the new device to already legally marketed devices rather than presenting data from a de novo clinical or performance study of the new device itself.

Here's an explanation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. No explicit acceptance criteria based on performance metrics (e.g., sensitivity, specificity, accuracy) are defined in this document for the UV Biotek devices. The "acceptance criteria" for a 510(k) submission seeking substantial equivalence is to demonstrate that the new device is as safe and effective as a predicate device, which is typically achieved through comparison of technological characteristics and intended use.

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

• Not Applicable. No specific "test set" or patient data was used to demonstrate the performance of the UV Biotek device itself in a study. The substantial equivalence argument is based on a comparison of device specifications and intended use against predicate devices.

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

• Not Applicable. As there was no specific study with a test set requiring ground truth establishment, this information is not relevant.

4. Adjudication Method for the Test Set:

• Not Applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No. An MRMC study was not conducted as this is not a study evaluating human reader performance with or without AI assistance, but rather a submission for a phototherapy device seeking substantial equivalence to predicate devices.

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

• Not Applicable. The device is a phototherapy unit, not an algorithm or AI system.

7. The Type of Ground Truth Used:

• Not Applicable.

8. The Sample Size for the Training Set:

• Not Applicable. The device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable.

Summary of the "Study" (Substantial Equivalence Argument):

The "study" in this context is the Substantial Equivalence Discussion presented in section 6 of the 510(k) summary.

• Argument: The manufacturer asserts that the UV Biotek Mobile-Lite model 600 and Versa-Lite model 1400 are substantially equivalent to five predicate devices (K050695, K872649, K933952, K031800, K904427).
• Methodology: The comparison is based on:
  • Intended Use: Both the proposed devices and the predicate devices are intended for "specific Ultraviolet radiation therapy for diagnosed skin disorders" and are used for "treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)".
  • Technological Characteristics: The devices share "the same technological characteristics," including:
    • Design
    • Material (Acrylic patient contact material, "well known and accepted")
    • Energy source (12v Power Adapter, 120v 60 hz)
    • Housing materials and construction (Steele safety shield, UV lamps, timer, googles)
    • Light source (Fluorescent Ultra Violet, specifically Narrowband UVB lamps, e.g., Philips TL-01, TL20W/01, PL-L36W/01)
    • Wavelength Range (311 nm Narrow Band UVB)
    • Power output (various wattages, but within similar ranges for phototherapy)
    • Treatment areas (hand and foot, spot, partial body)
    • Treatment regimes (prescribed by physician)
    • Methods of operation
• Conclusion of the Manufacturer: "no significant differences exist between the device and the predicates listed in section 5 of this summary."
• FDA Conclusion: The FDA reviewed the submission and concurred, stating the device is "substantially equivalent (for the indications of use stated in the enclosure) to legally marketed predicate devices."

Performance Standards:

While not a direct performance study, the devices are stated to be in compliance with established performance standards for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act. Specifically, they are OSHA/NRTL listed and comply with EN/IEC 60601-1-1 and EN/IEC 60601-1-2, which are general electrical safety and electromagnetic compatibility standards for medical electrical equipment. This demonstrates adherence to safety, but not clinical efficacy in the context of a specific trial.

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