(210 days)
This product is intended for the exclusive purpose of cosmetic tanning of the human skin using light between 260-400nm.
Light Sources UV Lamps for Indoor Tanning devices are ultraviolet lamps that have the same basic technological features and the same intended use. The ultraviolet sunlamps in this submission are classified either as low pressure, or high pressure devices. The main difference for the various models of sunlamps in this submission are: lamp wattage, lamp length, lamp diameter, and spectral emissions. Light Sources UV Lamps for Indoor Tanning devices are ultraviolet sunlamps classified either as low pressure, or high pressure devices emitting light between 260- 400nm. The basic parts are as follows: Bases, Glass Bulb (envelope), Electrodes (Cathodes/Coils), Phosphor Coating, Reflector Coating, Mercury, Inert fill gases.
The provided documentation is a 510(k) summary for "UV Lamps for Indoor Tanning Devices". This document outlines the regulatory submission for a Class II medical device. However, it does not describe a study that uses a test set, ground truth established by experts, or any of the metrics requested for assessing device performance in the context of an AI/ML powered medical device.
The "performance data" section refers to compliance with established international consensus standards and FDA performance standards, primarily related to electrical safety and radiation limits for UV lamps. It does not mention any clinical study or evaluation of a medical device's diagnostic or predictive capabilities.
Therefore, I cannot provide the requested information for acceptance criteria and device performance based on the input text. The information is not present in the document.
Missing Information/Not Applicable Based on Document Content:
- Acceptance Criteria Table: The document does not specify performance metrics like sensitivity, specificity, accuracy, or AUC, nor does it list acceptance criteria for such metrics. The "performance data" refers to compliance with safety and radiation standards, not diagnostic or AI-related performance.
- Sample Size for Test Set and Data Provenance: No test set is described in the context of diagnostic or predictive performance.
- Number of Experts and Qualifications: No experts are mentioned in the context of establishing ground truth for a test set.
- Adjudication Method: Not applicable as there's no test set involving expert review.
- MRMC Comparative Effectiveness Study: Not applicable. The device is a UV lamp, not an AI-powered diagnostic tool.
- Standalone Performance: Not applicable. This refers to an AI algorithm's performance without human intervention; the device is a physical product.
- Type of Ground Truth: Not applicable. There is no diagnostic ground truth mentioned.
- Sample Size for Training Set: Not applicable. The device is not an AI/ML algorithm that requires a training set.
- How Ground Truth for Training Set was Established: Not applicable.
What the document does include regarding performance:
The device's "performance" is demonstrated through its compliance with established safety and performance standards for sunlamp products:
- INTERNATIONAL CONSENSUS STANDARDS:
- IEC/EN 61195:2014 (Double Capped Fluorescent Lamps Safety Specifications)
- IEC/EN 60355-2-27 (Household and Electrical Appliances Safety Requirements for Skin Exposure for UV and IR Radiation)
- FDA PERFORMANCE STANDARDS:
- 21 CFR 1040.20 (Performance Standard For Sunlamp products and ultraviolet lamps intended for use in sunlamp products)
- Specific performance testing (spectral analysis) data was submitted to ensure compliance with radiation limits set out in 21 CFR 1040.20.
§ 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.