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The UV Biotek Multi-Directional device 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 Single Panel Unit device models 100B/80B/40B are 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 Multi-Directional model is a phototherapy device, wall mounted with 3 lighting panels containing a total of 10 Philips TL100W/01 (narrowband UVB) or 10 Philips FS72T12/BL/HO/12 (wideband UVB) lamps. The center panel contains 6 lamps and the outer panels contain 2 lamps each, driven by standard electrical lighting systems at 120 Volts, producing 1000 Watts of primary UVB emissions within an enclosed metal (structure) and acrylic (exposure) housing, that is utilized at a the patient's home by prescription, and only with protective eyewear, as outlined in 21 CFR 892.6500. Cabinet dimensions: 85.5" high, 9" deep, 22.5" wide – when the door panels are closed. A digital AccuSafe control timer module is used to program exposure times and dosages.

The UV Biotek Single Panel device is a phototherapy device, wall mounted with a single lighting panel with an array of 4, 6, 8 or 10 Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps, driven by standard electrical lighting systems at 120 Volts, producing 400 to 1000 Watts of primary UVB emissions within an enclosed metal (structure) and acrylic (exposure) housing, that is utilized at a the patient's home by prescription, and only with protective eyewear, as outlined in 21 CFR 892.6500.

Cabinet dimensions: 85.5" high, 5" deep, 22" wide – when door panels are closed. A digital AccuSafe control timer module is used to program exposure times and dosages.

There are 4 single panel models to choose from:
. The100B model is one metal cabinet, housing (10) Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.
The 80B model is one metal cabinet, housing (8) Philips TL100W/01 ● (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.
. The 60B model is one metal cabinet, housing (6) Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.
. The 40B model is one metal cabinet, housing (4) Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.

This document is a 510(k) premarket notification for the "UV Biotek Multi-Directional and UV Biotek Single Panel (models 100B/80B/60B/40B)". It claims substantial equivalence to a predicate device, the "UV Biotek Mobile/Versa Lite (K111049)". The provided text does not contain a study with acceptance criteria or reported device performance in terms of diagnostic accuracy or clinical outcomes for the treatment of dermatologic disorders.

Instead, the document details the device's technical specifications and asserts its equivalence to a predicate device based on similar characteristics and compliance with electrical safety and EMC standards.

Therefore, the requested information about acceptance criteria for a study demonstrating efficacy and device performance cannot be extracted from this document, as such a study is not described. The performance testing mentioned specifically related to "irradiance" and "comparison to the predicate device" to "reach the recommended dose (mJ/cm2) for the treatment of psoriasis found in published scientific literature", not a clinical study proving the device meets specific efficacy acceptance criteria.

However, based on the information provided, here's what can be inferred and stated:

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

The document does not provide a table of acceptance criteria for clinical efficacy (e.g., reduction in psoriasis severity scores) or diagnostic performance, nor does it report the device's performance against such criteria. The "Performance Standards" section (page 6) mentions:

• "These devices have been tested under and are in compliance with performance standards that have been established for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act." (general compliance)
• "All electrical and radiological products made by the applicant have been OSHA/NRTL listed, and have received constituent marks and are found to be in conformance with EN/IEC 60601-1 Electrical Safety and EN/IEC 60601-1-2:2007 EMC." (electrical and EMC safety)
• "Specific performance testing was done on these devices to measure irradiance and for comparison to the predicate device. These measurements were used to reach the recommended dose (mJ/cm2) for the treatment of psoriasis found in published scientific literature." (technical measurement for dosing, not clinical outcome)

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

Not applicable. The document does not describe a clinical test set or patient data.

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. The document does not describe a clinical test set or ground truth established by experts.

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

Not applicable. The document does not describe a clinical test set.

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 UV phototherapy device for treatment, not an AI-assisted diagnostic device.

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

Not applicable. This device is a UV phototherapy device for treatment, not an algorithm.

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

Not applicable. The document does not describe a clinical study requiring ground truth for clinical outcomes. The "performance testing" mentioned focuses on physical measurements (irradiance) rather than clinical efficacy. The basis for efficacy relies on the predicate device and "published scientific literature" for recommended doses of UV radiation for psoriasis treatment.

8. The sample size for the training set

Not applicable. The document does not describe an AI/ML model or a training set.

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

Not applicable. The document does not describe an AI/ML model or a training set.

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