(92 days)
INTENDED USE: This ultraviolet lamp is intended for use in sunlamp products for tanning of the human skin.
This 510(k) applies to more 35 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 high pressure, mercury-metal halide discharge devices. The general lamp construction and technological principle of operation of all of the devices of this 510(k) is the similar to that of commonly used metal halide lamps used for general lighting purposes. 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 quartz envelope, filled with an inert gas (such as argon) and a mixture of mercury and metal halide salts and sealed at both ends.
The provided text describes the substantial equivalence of Ultraviolet Lamps intended for use in sunlamp products to legally marketed predicate devices. It does not contain information about a study with acceptance criteria, sample sizes, expert involvement, or AI performance that would be typically found in a clinical study report for a new medical device.
The document is a 510(k) summary for a Class II medical device, which seeks to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria in a clinical setting. The "performance testing" mentioned refers to manufacturing quality control and verification that the new lamps meet the same characteristics as the predicate devices, not a clinical study.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is the information that can be extracted, interpreted based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document lists "Performance Testing Summary" which serves as the acceptance criteria for the manufactured lamps, demonstrating their equivalence to predicate devices.
| Test (Performance Criteria) | Reported Device Performance (Lamps meet criteria of predicate devices - Yes/No) |
|---|---|
| Functionality / Light up | Yes |
| Electrical Characteristics | Yes |
| Burn-in Behavior | Yes |
| Dimensional Characteristics | Yes |
| Mechanical Safety | Yes |
| Electrical Safety | Yes |
| UVA Irradiance | Yes |
| Erythemal Effective Irradiance | Yes |
| UVC/UVB Ratio (per 21 CFR1040.20) | Yes |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document states, "All lamps are 100% tested for functionality at the end of the manufacturing process." For other tests, it mentions, "According to a Quality Sampling Plan, lamps are tested in-process and / or post-production." The specific sample sizes for these sampling plans are not provided.
- Data Provenance: The data appears to be from internal manufacturing and quality control testing, but the country of origin is not specified. It is prospective in the sense that it's an ongoing manufacturing process quality control.
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 performance testing described is engineering and manufacturing verification against established technical specifications and regulatory requirements (21 CFR 1040.20), not a clinical evaluation requiring expert interpretation of results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for clinical studies with subjective assessments, which is not the nature of the described 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 is not an AI-enabled device, nor is it a diagnostic device that would typically undergo an MRMC study. The device is an ultraviolet lamp for tanning.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance testing is based on the technical specifications and regulatory requirements for safe and effective sunlamp operation, as demonstrated by the predicate devices. This includes electrical characteristics, mechanical safety, dimensional integrity, and specific UV radiation characteristics (UVA Irradiance, Erythemal Effective Irradiance, UVC/UVB ratio per 21 CFR 1040.20).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
§ 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.