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INTENDED USE: This ultraviolet lamp is intended for use in sunlamp products for tanning of the human skin.

This 510(k) applies to more 35 devices that fall into a generic class of ultraviolet lamps that have the same basic technological features and exactly the same intended use. The ultraviolet sunlamps of this 510(k) are classified scientifically as high pressure, mercury-metal halide discharge devices. The general lamp construction and technological principle of operation of all of the devices of this 510(k) is the similar to that of commonly used metal halide lamps used for general lighting purposes. The main differentiators for the various sunlamps of this 510(k) include: lamp length, lamp diameter, lamp wattage, spectral characteristics and private labeling thereof. The ultraviolet lamps named herein comprise a tubular quartz envelope, filled with an inert gas (such as argon) and a mixture of mercury and metal halide salts and sealed at both ends.

The provided text describes the substantial equivalence of Ultraviolet Lamps intended for use in sunlamp products to legally marketed predicate devices. It does not contain information about a study with acceptance criteria, sample sizes, expert involvement, or AI performance that would be typically found in a clinical study report for a new medical device.

The document is a 510(k) summary for a Class II medical device, which seeks to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria in a clinical setting. The "performance testing" mentioned refers to manufacturing quality control and verification that the new lamps meet the same characteristics as the predicate devices, not a clinical study.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is the information that can be extracted, interpreted based on the provided document:

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

The document lists "Performance Testing Summary" which serves as the acceptance criteria for the manufactured lamps, demonstrating their equivalence to predicate devices.

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

• Sample Size for Test Set: The document states, "All lamps are 100% tested for functionality at the end of the manufacturing process." For other tests, it mentions, "According to a Quality Sampling Plan, lamps are tested in-process and / or post-production." The specific sample sizes for these sampling plans are not provided.
• Data Provenance: The data appears to be from internal manufacturing and quality control testing, but the country of origin is not specified. It is prospective in the sense that it's an ongoing manufacturing process quality control.

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 performance testing described is engineering and manufacturing verification against established technical specifications and regulatory requirements (21 CFR 1040.20), not a clinical evaluation requiring expert interpretation of results.

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

Not applicable. This concept is relevant for clinical studies with subjective assessments, which is not the nature of the described testing.

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-enabled device, nor is it a diagnostic device that would typically undergo an MRMC study. The device is an ultraviolet lamp for tanning.

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.

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

The "ground truth" for the performance testing is based on the technical specifications and regulatory requirements for safe and effective sunlamp operation, as demonstrated by the predicate devices. This includes electrical characteristics, mechanical safety, dimensional integrity, and specific UV radiation characteristics (UVA Irradiance, Erythemal Effective Irradiance, UVC/UVB ratio per 21 CFR 1040.20).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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