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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 than one hundred and sixty individual 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 low pressure, mercury-rare gas discharge devices. The general lamp construction and technological principle of operation of all of the devices of this 510(k) is the same as that of a common fluorescent lamp. 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 glass envelope, the internal surface of which is coated with a fluorescent phosphor. To each end of the tube, a glass mount is sealed. The main purpose of the mount is to provide 1) for a means of hermetically sealing the internal atmosphere of the tube, 2) a means of supporting an electrode and a means of 3) electrically accessing the internal atmosphere of the device via electrically conducting lead-wires. Once assembled as described, the envelope is evacuated of air, the air is replaced by an inert gas at a pressure significantly lower than that of the normal atmosphere, and a drop of mercury is injected into the enclosed envelope. Finally, the envelope is sealed.

In operation, the device, now called a "lamp", is connected to an electrical source typically in series with a ballast that provides for 1) ignition of a discharge through the inert-gas-mercury vapor mixture and 2) its subsequent stabilization and sustainment of the electrical behavior of the lamp. Once connected to the applied electric field, free electrons are accelerated through the mercury vapor wherein collisions take place with the mercury atoms. These collisions cause excitation of the electrons in the mercury (Hq) atom and the production of photons at various wavelengths. Certain of these photons travel to the bulb wall and excite the phosphor powder. The phosphor, in turn, emits radiation that is transmitted through the transparent glass envelope. The radiation that is emitted from a standard fluorescent general lighting lamp is primarily in the visible region of the spectrum (380nm-760nm). The radiation that is emitted from an ultraviolet sunlamp is primarily in the UV range of the electromagnetic spectrum (300nm-400nm). Modern day, low pressure ultraviolet sunlamps typically emit most of their energy in the wavelength range that is closest to the visible: that is, in the UVA range (320nm-400nm) range. The emission spectrum of sunlamps usually contains a relatively small proportion of UVB radiation. (260nm-320nm)

The provided document is a 510(k) premarket notification for "Cosmedico Ultraviolet Lamps of Various Models." It does not describe an AI/ML powered device, but rather conventional sunlamp products. Therefore, the specific information requested about acceptance criteria and studies related to an AI/ML device's performance, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, is not applicable to this document.

The document indicates that the device is a conventional sunlamp and relies on equivalence to legally marketed predicate devices rather than novel AI/ML technology requiring specific performance studies as outlined in the request.

However, I can extract the acceptance criteria and a summary of performance testing for the conventional device as described in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "According to a Quality Sampling Plan, lamps are tested in-process and / or post-production". It does not specify the exact sample size for the test set or the data provenance beyond "Quality Sampling Plan". Given the nature of the device (sunlamps), the tests are likely conducted on manufactured samples, which implies prospective testing during or after production. There is no information regarding the country of origin of the data.

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 device is a conventional sunlamp, and its performance is measured against technical specifications and predicate device characteristics, not through expert-labeled ground truth for diagnostic purposes. Performance testing involves physical and electrical measurements.

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

Not applicable. Adjudication methods are typically relevant for subjective assessments by multiple human readers, often in image interpretation or clinical scenarios where ground truth is expert-derived. This device undergoes objective performance 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 device is not an AI-powered system designed to assist human readers.

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

Not applicable. This device is not an algorithm or AI system.

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

The "ground truth" for these sunlamps is their conformance to established technical specifications and performance characteristics, which are compared to legally marketed predicate devices. This includes objective measurements of electrical characteristics, dimensions, mechanical safety, UV radiation characteristics (UVA Irradiance, Erythemal Effective Irradiance, UVC/UVB ratio), and functionality. It is not an expert consensus, pathology, or outcomes data ground truth as would be used for a diagnostic AI device.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that undergoes a training phase.

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

Not applicable. This device is not an AI/ML model.

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