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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

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Intended to provide ultraviolet light to tan the skin

Tanning lamp is electronic products to be intended for irradiation of any part of the living human body, by ultraviolet radiation with wavelengths to induce skin tanning.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tanning Lamp (K143043).

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain detailed information about a comprehensive clinical study to "prove the device meets acceptance criteria" in the way a novel, high-risk device might. Instead, it relies on demonstrating similar performance to a legally marketed predicate device.

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" here are based on the concept of substantial equivalence to the predicate device. This means the new device must perform comparably in key technological characteristics and safety aspects.

Study Details

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify a numerical sample size for "test sets" in the traditional sense of a clinical trial. Instead, the "test" involved direct comparisons of the new device (Unilam UV lamps) and the predicate device (Cosmedico UV lamps) based on their intrinsic properties. It refers to "individual test data sheets" for each bulb. This implies that at least one of each relevant bulb model from Unilam and Cosmedico was tested for the specified parameters.
   • Data Provenance: The studies were "Performance studies... comparing the Unilam UV lamps to the predicate Cosmedico UV lamps." This suggests the data was generated specifically for this 510(k) submission, likely in a controlled laboratory setting. The origin of the devices themselves is implied: Unilam Co., Ltd. (Republic of Korea) and NARVA LICHTQUELLEN GMBH + CO KG (predicate). The document does not specify if the tests were retrospective or prospective, but for laboratory performance testing like this, it would be prospective in relation to the submission.

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

   • Not Applicable. For a device like a tanning lamp, the "ground truth" for performance is based on quantifiable physical measurements (wavelengths, energy output, electrical characteristics) conducted by qualified technical personnel using calibrated equipment, not on expert clinical consensus or interpretation in the way a diagnostic imaging device might be evaluated.

3. Adjudication method for the test set:

   • Not Applicable. As the "ground truth" is based on objective physical measurements, there's no need for an adjudication method involving multiple human reviewers.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This device is a tanning lamp, which is an energy-delivering device, not a diagnostic or AI-powered device that involves "human readers" or AI assistance.

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

   • No. This is not an algorithm-based device.

6. The type of ground truth used:

   • The "ground truth" was established through objective physical measurements and technical specifications of the lamps. This includes:
     • Electrical power requirements
     • Spectral output (in nm increments)
     • Energy output (UVA and UVB range)
     • Approximate lifetime
     • Physical dimensions and connector design

7. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device, so there is no training set in that context. The device's characteristics are determined by its manufacturing, not by being "trained" on data.

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set, there is no ground truth to establish for it.

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