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This ultraviolet lamp is intended for use in sunlamp products for tanning of human skin.

The component ultraviolet lamp model family or part numbers are for use in sunlamp products to tan human skin. They fall into a generic class of UV lamps that have the same basic technological features, characteristics, except for power rating, diameter and length, with the exact same intended use. The UV sunlamp model family are for tanning human skin use. They vary in brand ID and unique lamp ratings accordingly. These sunlamps fit into a wavelength range of 200-710nm and operate from the end product ballast supply.

There are individual component sunlamps listed in the exhibit page. They are classified as low pressure, mercury rare gas discharge devices and generally have the same construction and technical principals of operation as that of a common fluorescent lamp. The UV lamps have a tubular glass envelope with internal surface coated with fluorescent phosphor. The sealed lamps include the composition and electrical means to activate the UV light within the wavelength specification. The construction is controlled by production procedures and test methods defined in the QMS. The UV radiation is controlled by these methods to assure safe use.

This document is a 510(k) summary for UV Lamps for Sunlamp Products (K180581). It describes the device, its intended use, predicate devices, and the performance data and design control activities. However, it does not contain the information required to answer your specific questions relating to acceptance criteria and a study that proves the device meets the acceptance criteria in the context of clinical performance or algorithm evaluation.

This document is a regulatory submission for a physical device (UV lamps), not an AI/ML software device. As such, concepts like "acceptance criteria and reported device performance" as you've framed them (often related to diagnostic accuracy, sensitivity, specificity), "sample size for test set," "data provenance," "ground truth experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "training set details" are not applicable to this type of device and submission.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications, compliance with international consensus standards, and a quality management system.

Here's a breakdown of what is available in the document and why other requested information is not present:

Information Present in the Document (and its interpretation for this context):

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

   • Acceptance Criteria (as regulatory compliance): The device (UV Lamps) must comply with:
     • IEC/EN 61195:2014 - Double Capped Fluorescent Lamps Safety Specifications
     • IEC/EN 60355-2-27:2013 - Particular Appliances Safety Requirements for Skin Exposure to UV and IR Radiation
     • EN60081:1998 - Double Capped Fluorescent Lamps - Performance Specifications
     • EN61228:2008 - Fluorescent Ultraviolet Lamps Used for Tanning. Measurement and Specification Method
     • EN62471:2008- Photobiological Safety of Lamps and Lamp Systems
     • EN50581: 2012 - Technical Documentation for the Assessment of Electrical and Electronic with Respect to the Restriction of Hazardous Substances
     • 21 CFR 1040.20 - Performance standard for sunlamp products and ultraviolet lamps intended for the use in sunlamp products (FDA mandatory standard).
     • ISO9001 Quality Management System.
   • Reported Device Performance (as compliance with the above): The document states:
     • "The Feilo Sylvania UV lamps are intended for use in sunlamp products for tanning of human skin comply with the consensus standards and specifications listed below and are therefore validated as safe for the intended use."
     • "Specific performance testing (spectral analysis) data is submitted to CDRH for the component UV lamps with measurement of irradiance to verify compliance with radiation limits defined in 21CFR1040.20."
     • "The control activity shows that there are no new questions of safety and effectiveness for the described UV Sunlamps."
     • "Inspection verification procedures assure performance concerns are compliant to QMS specifications."
     • The comparison table (page 5) lists "Radiation 21CFR1040.20" for the Feilo Sylvania device and "CDRH compliant" for predicate devices, implying adherence.

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

   • Not applicable/Not mentioned in the document. This is not a study involving human subjects or data sets in the typical sense of software or diagnostic device evaluations. Performance testing would be on the physical lamps themselves, but sample sizes for this are not specified.

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 is a physical device, not an AI/ML or diagnostic tool where expert ground truth is typically established.

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-assisted device.

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

   • Not applicable. This is not an algorithm.

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

   • Not applicable in the typical sense. The "ground truth" here is compliance with established engineering and safety standards (e.g., spectral characteristics, irradiance limits as defined in 21CFR1040.20, safety specifications for lamps).

8. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

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

   • Not applicable.

In summary, this 510(k) pertains to a hardware device (UV lamps) and therefore the questions are largely incongruent with the information and type of study presented. The "study" here is essentially the demonstration of compliance with established engineering and regulatory performance standards through internal testing and external certifications, rather than a clinical trial or algorithm validation study.

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