(173 days)
Sunlamp product intended for use to tan the skin.
The submission covers several models of sunlamp products: B-Phase, HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, and Vega Lux. These devices are either stand-up units (booths) or beds with UV low pressure or high pressure lamps intended for tanning the skin. Some models include visible red-light lamps or facial tanning lamps. The lamps are separated from the user by acrylic panels or glass filters. The devices have metal body frames covered by plastic panels and include electrical components and control boards. Safety features like control switches that interrupt power if doors are opened or filters are removed are present in some models. Associated sunlamps and protective eyewear are also mentioned.
This document is a 510(k) Premarket Notification from the FDA regarding several sunlamp products. It is not a study proving a device meets acceptance criteria. The document explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This means the FDA has determined these new devices are substantially equivalent to existing, legally marketed sunlamp products, not that a specific study was conducted to prove they meet novel acceptance criteria through a clinical trial or performance study against a defined set of metrics in a medical context.
Therefore, most of the information requested in your prompt (acceptance criteria, device performance, sample size, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) will not be present in this document because it describes a different kind of regulatory submission.
However, I can extract the limited performance and safety information that is mentioned:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated Compliance) | Reported Device Performance |
|---|---|
| Performance Standard 21 CFR 1040.20 | Devices were tested to be in conformity with Performance Standard 21 CFR 1040.20. |
| Biocompatibility (for contacting materials) | The polymethyl methacrylate (PMMA) that contacts skin was shown to be biocompatible via European standard 30993 (which corresponds to ISO 10993). |
| Electrical safety | Electrical safety testing was conducted on all devices, which were shown to pass the tests conducted. |
| Electromagnetic compatibility (EMC) | EMC testing was conducted on all devices, which were shown to pass the tests conducted. |
| Software Verification and Validation | Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern. |
2. Sample size used for the test set and the data provenance
The document does not detail specific sample sizes for testing, nor does it refer to a "test set" in the context of clinical or performance data collection on human subjects or diagnostic samples. The testing appears to be primarily engineering and safety compliance. Data provenance (country of origin, retrospective/prospective) is not applicable or stated for this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" for a test set in a medical diagnostic or treatment performance context is established or mentioned. The compliance is against engineering standards and material biocompatibility standards.
4. Adjudication method for the test set
Not applicable. No "test set" requiring adjudication in a clinical or diagnostic sense is described.
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 (a sunlamp) does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical sunlamp, not an algorithm.
7. The type of ground truth used
For the biocompatibility testing, the "ground truth" (or standard) used was European standard 30993 (corresponding to ISO 10993). For performance, electrical safety, and EMC, the "ground truth" was compliance with 21 CFR 1040.20 and successful completion of respective tests. For software, it was compliance with FDA's guidance for software in medical devices.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable.
Summary of the document's purpose:
This document is an FDA 510(k) clearance letter, indicating that the listed sunlamp devices are "substantially equivalent" to predicate (already legally marketed) devices. The "study" mentioned is primarily a series of engineering and safety tests to confirm compliance with established regulatory standards (like 21 CFR 1040.20 for sunlamp products, ISO 10993 for biocompatibility, and general electrical/EMC safety standards), rather than a clinical trial or performance study against a specific disease or diagnostic outcome. The acceptance criteria relate to compliance with these standards and established safety guidelines, rather than metrics like sensitivity, specificity, or reader performance typical of diagnostic devices.
§ 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.