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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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