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This sunlamp product is intended exclusively for cosmetic tanning of the human skin, for one person at a time, at the age of 18 or above.

The primary technical components of sunlamp products are artificial sources of UV radiation (UV lamps) and a mechanical structure. UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly, the UV-B radiation is primarily responsible for more long-term tanning results.

The provided text is a 510(k) summary for the JK-Holding GmbH's Sunrise 6200 and Sunrise 7200 tanning devices. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study methodologies, and performance metrics are not available in this document. The document describes the device, its intended use, and compares it to a predicate device in terms of technical characteristics and compliance with electrical/safety standards.

Here's an attempt to answer the questions based only on the provided text, noting where information is absent:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for performance in terms of cosmetic tanning effectiveness. Instead, it focuses on compliance with established safety and electrical standards and showing that the proposed device is technologically equivalent to a predicate. The "performance" reported is compliance with these standards and similar technical specifications.

2. Sample size used for the test set and the data provenance

The document mentions "Summary of performance testing" and indicates that "The proposed devices have been tested in respect to biocompatibility in accordance with the ISO 10993-series, electrical and mechanical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2." and "The proposed devices are in compliance with U.S. performance standard 21CFR 1040.20." It also refers to "section 18 for bench test report" regarding irradiance ratio.

• Sample Size: Not specified for any of the tests. This refers to physical devices tested, not clinical data sets.
• Data Provenance: The tests are likely conducted in a lab setting by the manufacturer or a third-party testing facility. The manufacturer is based in Germany. The document is for submission to the U.S. Food & Drug Administration (FDA). The nature of these tests (safety, electrical, EMC) implies them to be prospective, laboratory-based tests on the devices themselves. No human or patient data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The "ground truth" for this device relates to its compliance with technical standards (e.g., electrical safety, UV irradiance limits). This is measured through instrumental testing and adherence to published standards, not through expert human assessment of an outcome like a medical diagnosis.

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

Not applicable and not provided. Adjudication methods like 2+1 or 3+1 typically apply to human interpretation of medical imaging or clinical cases where consensus is needed to establish ground truth for algorithm performance. For a tanning device, compliance is determined by instrumental measurements and adherence to engineering standards.

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 and not provided. This is a tanning device, not an AI-powered diagnostic tool requiring human-in-the-loop studies.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable and not provided. There is no mention of an algorithm or AI component in this device. The "performance" relates to the physical device's technical specifications and safety compliance.

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

The "ground truth" for the tests performed (biocompatibility, electrical safety, EMC, irradiance ratio) would be defined by the specifications and limits set forth in the referenced international standards (e.g., ISO 10993, IEC 60601-1, IEC 60601-1-2, 21 CFR 1040.20). Compliance is determined by direct physical measurement against these established benchmarks.

8. The sample size for the training set

Not applicable and not provided. This is generally a physical product, not a machine learning model. There is no mention of a training set.

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

Not applicable and not provided, as there is no training set mentioned for this product.

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