(89 days)
This sunlamp product is intended exclusively for cosmetic 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 (UV lamps) and a mechanical structure. 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.
The provided text is a 510(k) summary for the JK-Holding GmbH's Sunrise 6200 and Sunrise 7200 tanning devices. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study methodologies, and performance metrics are not available in this document. The document describes the device, its intended use, and compares it to a predicate device in terms of technical characteristics and compliance with electrical/safety standards.
Here's an attempt to answer the questions based only on the provided text, noting where information is absent:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for performance in terms of cosmetic tanning effectiveness. Instead, it focuses on compliance with established safety and electrical standards and showing that the proposed device is technologically equivalent to a predicate. The "performance" reported is compliance with these standards and similar technical specifications.
| Parameter (Implied Acceptance Criteria) | Predicate Device (Sunrise 480) Performance | Proposed Device (Sunrise 6200/7200) Performance | Evaluation against Implied Criteria |
|---|---|---|---|
| Intended Use/Indications for Use | Cosmetic tanning of human skin for one person, age 18+ | Cosmetic tanning of human skin for one person, age 18+ | Identical (Meets criterion for equivalence) |
| Number of body lamps | 48 | 48 | Identical (Meets criterion for equivalence) |
| Watts (per lamp) | 200 | 200 | Identical (Meets criterion for equivalence) |
| Max exposure time [min] | 9 | 9 | Identical (Meets criterion for equivalence) |
| Electrical requirements | 230V 3Ø or 230V 2Ø | 230V 3Ø or 230V 2Ø | Identical (Meets criterion for equivalence) |
| Rated overcurrent protection device | 40A / 3-pole 3Ø or 70A / 2-pole 2Ø | 40A / 3-pole 3Ø or 70A / 2-pole 2Ø | Identical (Meets criterion for equivalence) |
| Number of wires | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | Identical (Meets criterion for equivalence) |
| Irradiance ratio in accordance with 1040.20 | Fulfilled | Fulfilled | Identical (Meets criterion for compliance) |
| Electrical safety (IEC 60601-1, UL 482, IEC 60335-2-27) | Compliant | Compliant | Identical (Meets criterion for compliance) |
| Electromagnetic compatibility (IEC 60601-1-2) | Compliant | Compliant | Identical (Meets criterion for compliance) |
| Total power consumption [Watts] | 11300 | 9500 | Similar: Less consumption, performance not impaired (Meets criterion for equivalence) |
| Lamp item description | GENESIS VHP12 Turbo Power - 200 W | GENESIS VHP9 Smart Performance 200 W | Different description, identical nominal wattage (Meets criterion for equivalence) |
2. Sample size used for the test set and the data provenance
The document mentions "Summary of performance testing" and indicates that "The proposed devices have been tested in respect to biocompatibility in accordance with the ISO 10993-series, electrical and mechanical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2." and "The proposed devices are in compliance with U.S. performance standard 21CFR 1040.20." It also refers to "section 18 for bench test report" regarding irradiance ratio.
- Sample Size: Not specified for any of the tests. This refers to physical devices tested, not clinical data sets.
- Data Provenance: The tests are likely conducted in a lab setting by the manufacturer or a third-party testing facility. The manufacturer is based in Germany. The document is for submission to the U.S. Food & Drug Administration (FDA). The nature of these tests (safety, electrical, EMC) implies them to be prospective, laboratory-based tests on the devices themselves. No human or patient data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The "ground truth" for this device relates to its compliance with technical standards (e.g., electrical safety, UV irradiance limits). This is measured through instrumental testing and adherence to published standards, not through expert human assessment of an outcome like a medical diagnosis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable and not provided. Adjudication methods like 2+1 or 3+1 typically apply to human interpretation of medical imaging or clinical cases where consensus is needed to establish ground truth for algorithm performance. For a tanning device, compliance is determined by instrumental measurements and adherence to engineering standards.
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 and not provided. This is a tanning device, not an AI-powered diagnostic tool requiring human-in-the-loop studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable and not provided. There is no mention of an algorithm or AI component in this device. The "performance" relates to the physical device's technical specifications and safety compliance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed (biocompatibility, electrical safety, EMC, irradiance ratio) would be defined by the specifications and limits set forth in the referenced international standards (e.g., ISO 10993, IEC 60601-1, IEC 60601-1-2, 21 CFR 1040.20). Compliance is determined by direct physical measurement against these established benchmarks.
8. The sample size for the training set
Not applicable and not provided. This is generally a physical product, not a machine learning model. There is no mention of a training set.
9. How the ground truth for the training set was established
Not applicable and not provided, as there is no training set mentioned for this product.
§ 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.