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510(k) Data Aggregation
(120 days)
These devices are UV-B and UV-A lamps intended to provide ultraviolet radiation to tan the skin.
These UV Tanning lamps are medium pressure halide lamps with a quartz glass bulb, filled with metal halide, mercury and argon gas, equipped with 2 electrodes and a socket to provide ultraviolet radiation to induce skin tanning at any part of the living human body.
The provided text describes a 510(k) premarket notification for an "Ultraviolet Sun Tanning Lamp" and focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria through a study. Therefore, much of the requested information regarding acceptance criteria, study details, human readers, and ground truth is not present in this document.
However, I can extract the information that is available and clarify what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Requirements) | Reported Device Performance |
|---|---|
| Requirements of 21 CFR 878.4635 | Fulfilled |
| Performance Standard 21 CFR 1040.20 | Fulfilled |
| Irradiance values per nanometer (Watt/cm²/nm) over wavelength range of 200 to 400 nm | Reported in "product reports" |
| Irradiance ratios (<0.003) as required per 21 CFR 1040.20(c)(1) | Reported in "product reports" |
| Quality control | Reported in "product reports" |
| Life & reliability testings | Reported for each single lamp model in the "product reports" |
| EN 60335-2-27 "Safety of household and similar electrical appliances. Part 2: Particular requirements for appliances for skin exposure to ultraviolet and infrared radiation." | Passed all testing in accordance with national and international standards |
| Device Risk Analysis per ISO 14971 | Passed all testing in accordance with national and international standards |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "each single lamp model" for reporting performance data in "product reports."
- Data Provenance: Not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Ground Truth Experts: Not applicable. This device is not an AI/diagnostic device that typically requires expert consensus for ground truth. The "ground truth" here is the adherence to regulatory and performance standards.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Not applicable. This device is not an AI/diagnostic device that typically uses adjudication for performance evaluation.
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 is not an AI-assisted diagnostic device, so no MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The "performance testing" was conducted on the lamp itself.
7. The type of ground truth used:
- The "ground truth" for this device's performance is compliance with established electrical, safety, and radiation emission standards and regulations (e.g., 21 CFR 878.4635, 21 CFR 1040.20, EN 60335-2-27, ISO 14971).
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that uses training sets.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
Study Description (as per the document):
The document describes a "performance testing" conducted to demonstrate that the Ultraviolet Sun Tanning Lamp meets certain regulatory and performance standards and is substantially equivalent to a predicate device.
- Objective: To verify that the lamps emit UV-B and UV-A radiation and fulfill the requirements of 21 CFR 878.4635 and the performance standard 21 CFR 1040.20. It also aimed to compare the irradiance performance of the proposed device to the predicate Unilam tanning lamp.
- Methodology: The "performance testing" involved evaluating:
- Spectral characteristics (plot of spectral irradiance 200-710 nm).
- Irradiance values per nanometer (Watt/cm²/nm) over the wavelength range of 200 to 400 nm.
- Irradiance ratios (<0.003) as required per 21 CFR 1040.20(c)(1).
- Quality control assessments.
- Life & reliability testings.
- Compliance with EN 60335-2-27 and Device Risk Analysis per ISO 14971.
- Results: The "Ultraviolet Sun Tanning Lamp devices passed all the testing in accordance with national and international standards." The results for specific measurements (spectral characteristics, irradiance values/ratios, quality control, life & reliability) are reported "for each single lamp model in the 'product reports'."
- Conclusion: The non-clinical testing and device characteristics detailed in the submission support the substantial equivalence of the device to the predicate device, specifically regarding its safety and effectiveness.
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed clinical study results typical for an AI-powered diagnostic device. The "study" here is a series of non-clinical performance and compliance tests.
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