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510(k) Data Aggregation
(265 days)
These devices are UV-B and UV-A lamps intended to provide ultraviolet radiation to tan the skin.
The Unilam Tanning lamps are high-pressure metal-halide lamps, each comprised of a quartz glass bulb filled with metal halide, mercury, and argon gas, and equipped with 2 electrodes and an electrical connector, to provide ultraviolet light in order to tan the human body.
The provided document is a 510(k) summary for a "Tanning Lamp" and focuses on demonstrating substantial equivalence to a predicate device. It does not describe a study involving algorithms, AI, or human readers. Therefore, most of the requested information regarding acceptance criteria, study design for AI models, human expert involvement, and ground truth establishment for such studies is not available in the document.
However, I can extract the information related to the device's performance criteria mentioned in the document as part of its substantial equivalence claim.
Here's the relevant information based on the document:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Regulatory Standard) | Reported Device Performance |
|---|---|
| Requirements of 21 CFR 878.4635 (Sunlamp Products and Ultraviolet Lamps) | The subject device emits UV-B and UV-A radiation and fulfills the requirements of 21 CFR 878.4635. |
| Performance standard 21 CFR 1040.20 (Sunlamp Products) | The subject device fulfills the requirements of 21 CFR 1040.20. |
| Ratio of UV-C (200-260nm) to UV-B (260-320nm) < 0.003 (per 21 CFR 1040.20(C)(1)) at any distance and direction from the product or lamp | The ratio of UV-C (200-260mm) to UV-B (260-320nm) meets the requirement (<0.003) per 21 CFR 1040.20(C)(1) at any distance and direction from the product or lamp. Additionally, UVC is cut by the quartz bulb (Technical Characteristic). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not applicable and not provided. The study performed was a non-clinical performance test of the device's UV emission characteristics against regulatory standards, not involving a test set of data in the context of AI/algorithm performance.
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. This document describes performance testing of a physical lamp against regulatory standards, not the evaluation of an AI model with expert-annotated ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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/software device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the established regulatory standards and performance requirements specified in 21 CFR 878.4635 and 21 CFR 1040.20 for sunlamp products. The device's performance was measured and compared directly to these objective, quantitative standards.
8. The sample size for the training set
- Not applicable. This document does not describe the development or training of an AI model.
9. How the ground truth for the training set was established
- Not applicable.
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