(129 days)
This sunlamp product is intended exclusively for aesthetic 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 as well as a mechanical structure with a defined active surface. 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. Using traditional UV light with the combination of red and blue light the user indulges in a new luxurious tanning experience. Optimal tanning results are achieved due to the synergistic combination of light spectra.
The provided text is a 510(k) Summary of Safety and Effectiveness for sunlamp products. It details comparisons between proposed devices and legally marketed predicate devices to demonstrate substantial equivalence, rather than providing an acceptance criteria table and a study proving a device meets those criteria in the context of an AI/algorithm-driven medical device.
The document does not contain information relevant to AI/algorithm performance, ground truth establishment, sample sizes for training/test sets, or expert review processes for such devices. Therefore, I cannot generate the requested table and study description based on the provided text.
The text focuses on hardware comparison and compliance with established performance standards for sunlamp products (e.g., IEC 60601-1 for electrical and mechanical safety, IEC 60601-1-2 for EMC, and U.S. performance standard 21CFR 1040.20 for irradiance ratio).
To summarize why I cannot fulfill your request:
- No AI/Algorithm Component: The submitted document describes sunlamp products, which are physical devices. There is no mention of any AI component, algorithm, or software that would require performance evaluation metrics like sensitivity, specificity, or AUC, nor would it involve concepts like "ground truth" derived from expert consensus or pathology for diagnostic purposes.
- Performance Testing Focus: The "Summary of performance testing" section clearly states that the devices were tested for "biocompatibility," "electrical and mechanical safety," and "EMC," and compliance with "U.S. performance standard 21CFR 1040.20" (which pertains to sunlamp products and their UV emissions). These are physical device performance criteria, not AI/algorithm performance.
- Comparative Approach: The entire document is structured as a comparison (substantial equivalence) to predicate devices, demonstrating that new models are similar in technology, intended use, and safety to already cleared devices, rather than a novel device proving its effectiveness against a set of performance criteria through a clinical study.
Therefore, the requested information (Acceptance Criteria Table, Sample Sizes for Test/Training, Expert Ground Truth, Adjudication, MRMC study, Standalone performance, Type of Ground Truth, Training Set Size, Training Ground Truth) is not present in the provided document because it describes a different type of medical device lacking an AI/algorithm component.
§ 878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
(a)
Identification. A sunlamp product is any device designed to incorporate one or more ultraviolet (UV) lamps intended for irradiation of any part of the living human body, by UV radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning. This definition includes tanning beds and tanning booths. A UV lamp intended for use in sunlamp products is any lamp that produces UV radiation in the wavelength interval of 200 to 400 nanometers in air.(b)
Classification. Class II (special controls). The special controls for sunlamp products and UV lamps intended for use in sunlamp products are:(1) Conduct performance testing that demonstrates the following:
(i) Device meets appropriate output performance specifications such as wavelengths, energy density, and lamp life; and
(ii) Device's safety features, such as timers to limit UV exposure and alarms, function properly.
(2) Demonstrate that device is mechanically safe to prevent user injury.
(3) Demonstrate software verification, validation, and hazard analysis.
(4) Demonstrate that device is biocompatible.
(5) Demonstrate that device is electrically safe and electromagnetically compatible in its intended use environment.
(6)
Labeling —(i)Sunlamp products. (A) The warning statement below must appear on all sunlamp products and must be placed in a black box. This statement must be permanently affixed or inscribed on the product when fully assembled for use so as to be legible and readily accessible to view by the person who will be exposed to UV radiation immediately before the use of the product. It shall be of sufficient durability to remain legible throughout the expected lifetime of the product. It shall appear on a part or panel displayed prominently under normal conditions of use so that it is readily accessible to view whether the tanning bed canopy (or tanning booth door) is open or closed when the person who will be exposed approaches the equipment and the text shall be at least 10 millimeters (height). Labeling on the device must include the following statement: Attention: This sunlamp product should not be used on persons under the age of 18 years. (B) Manufacturers shall provide validated instructions on cleaning and disinfection of sunlamp products between uses in the user instructions.
(ii)
Sunlamp products and UV lamps intended for use in sunlamp products. Manufacturers of sunlamp products and UV lamps intended for use in sunlamp products shall provide or cause to be provided in the user instructions, as well as all consumer-directed catalogs, specification sheets, descriptive brochures, and Web pages in which sunlamp products or UV lamps intended for use in sunlamp products are offered for sale, the following contraindication and warning statements:(A) “Contraindication: This product is contraindicated for use on persons under the age of 18 years.”
(B) “Contraindication: This product must not be used if skin lesions or open wounds are present.”
(C) “Warning: This product should not be used on individuals who have had skin cancer or have a family history of skin cancer.”
(D) “Warning: Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”
(c)
Performance standard. Sunlamp products and UV lamps intended for use in sunlamp products are subject to the electronic product performance standard at § 1040.20 of this chapter.