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Medtek Lighting, LLC's Peacock Tanning, Express Tan Models 1000HT, 2000CT, 2000HT, 3200 are intended to provide ultraviolet light to tan the skin, in male and female users, not under the age of 18 years.

The Express Tan 1000HT device is a skin tanning device, wall mounted or used on an accessory stand with a single lighting panel with 10 Cosmedico (T12/F71"/100w) lamps, driven by standard electrical lighting systems at 120 Volts, producing primary UV-A emissions within an enclosed metal (structure) and acrylic (exposure) housing and utilized only with included protective eyewear, as outlined in 21 CFR 1040.20 (c). A digital timer is used to program exposure times. Cabinet dimensions: 85.5" high, 5" deep, 22" wide - when door panels are closed. A digital control timer module is used to program exposure times.

The Express Tan models1600HT/2000CT/2000HT/3200 are skin tanning devices, wall mounted with 4 lighting panels containing an array of a total of 16, 20, or 32 Cosmedico (T12/F71"/100w) lamps, driven by standard electrical lighting systems at 120 Volts, producing UV-A emissions within an enclosed metal (structure) and acrylic (exposure) housing, and that is utilized only with included protective eyewear, as outlined in 21 CFR 1040.20 (c). A digital timer is used to program exposure times. Cabinet dimensions: 92" high, 8" deep, 50" wide - when panels are closed.

This document is a 510(k) premarket notification for a tanning device, not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not applicable in the context of an AI/ML device.

The document discusses the substantial equivalence of the "Peacock Tanning, Express Tan Models" to predicate devices based on intended use, technological characteristics, and conformance to special controls and performance standards.

Here's the relevant information that can be extracted from the provided text, adapted to the closest interpretations:

1. Table of Acceptance Criteria and Reported Device Performance

• Electrical Safety: IEC/EN 60601-1:2005 Edition 3 / A1:2012 (General II (ES/EMC))
• EMC: IEC 60601-1-2 Edition 4: 2014 (General II (ES/EMC))
  They are also "in compliance with performance standards that have been established for such devices under Section 1040.20 of the Federal Food, Drug, and Cosmetics Act."
• Specific performance testing (spectral analysis) was done to measure irradiance to ensure compliance with radiation limits set out in 21 CFR 1040.20.
• Specific performance testing was done on the included protective eyewear (goggles) to ensure spectral transmittance did not exceed value limits set out in 21 CFR 1040.20 while allowing visibility for timer reset. |
  | Safety Features | Devices for home use (Models 1000HT/1600HT/2000HT) must include specific safety training, warnings, contraindications, precautions, emergency shut-off, photosensitizing agents list, an exposure log, and a risk acknowledgment certification for consumers. | For home environment models, the sponsor "provides training to the consumer before the product is shipped out." This training includes a User Manual overview, help in determining skin type/exposure schedules, warnings, contraindications, precautions, safety features (e.g., emergency shut-off), a list of photosensitizing agents, a "Tanning Exposure Log," and a "Risk Acknowledgement Certification" form, which consumers must sign. |
  | Age Restriction | The device should be used by individuals not under the age of 18 years. | The devices are "intended to provide ultraviolet light to tan the skin, in male and female users, not under the age of 18 years." The consumer training emphasizes "Tanning bed is not to be used by any person under the age of 18 years." |

Since this is not an AI/ML device, the following points are not applicable (N/A):

2. Sample sized used for the test set and the data provenance: N/A (no AI/ML algorithm or test set in this context)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (no ground truth in the AI/ML sense)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A
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: N/A
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A
8. The sample size for the training set: N/A
9. How the ground truth for the training set was established: N/A

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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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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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Sec. 878.4630, Ultraviolet lamp for dermatologic disorders - to provide ultraviolet (UVB) radiation of the body to photoactivate a drug in the treatment of dermatologic disorders.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called UVBioTek 3200B / 4000B, an ultraviolet lamp for dermatologic disorders. This type of document does not contain information about acceptance criteria, study designs, or performance metrics in the way a clinical study report or a premarket approval (PMA) application would.

The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove efficacy or safety through new clinical studies. Therefore, the detailed information requested in your prompt (acceptance criteria, study design, sample sizes, expert qualifications, etc.) is not present in this document.

Here's why and what can be inferred:

• Acceptance Criteria and Reported Device Performance: Not applicable and not present. A 510(k) submission generally compares technical specifications and potentially safety data to a predicate, rather than setting and reporting against specific performance acceptance criteria from a new clinical study.
• Sample size for test set and data provenance: No new test set or clinical study data is reported here. The substantial equivalence is based on comparison to an existing predicate.
• Number of experts and qualifications, adjudication method: Not applicable as no new clinical study requiring expert review is described.
• MRMC comparative effectiveness study: Not mentioned and highly unlikely for a 510(k) for this type of device.
• Standalone performance: Not applicable in the context of this 510(k) summary.
• Type of ground truth used: Not applicable as there's no new data being generated through a study requiring ground truth establishment.
• Sample size for training set: Not applicable as this is not an AI/machine learning device requiring a training set in the conventional sense.
• How ground truth for training set was established: Not applicable for the same reason as above.

In summary, this document is a regulatory approval based on demonstrating substantial equivalence to a predicate device, not a report of a study proving a device meets specific performance criteria through new data.

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