(427 days)
KBL Sunlamp Products are over-the-counter tanning devices emitting ultraviolet light in the UVB and UVA region of the spectrum intended for tanning of the human skin of an adult person.
KBL Sunlamp Products are whole-body tanning devices basically consisting of a mechanical structure equipped with artificial light sources producing ultraviolet light in the UVA and UVB region of the light spectrum. The UV light is intended for irradiation of any part of the living human body to induce skin tanning. The UVA light primarily generates a superficial tan which appears rapidly and is intensive but also fades more rapidly whereas the UVB light generates more long term tanning results. The user is either standing in the middle of the KBL Sunlamp Product if it is a vertical device (tanning tower) or lying on a bench if it is a horizontal device (tanning bed).
The provided document is a 510(k) premarket notification for KBL Sunlamp Products, seeking to demonstrate substantial equivalence to legally marketed predicate devices. It describes the devices, their intended use, and provides a comparison of technological characteristics. Crucially, this document does not describe the acceptance criteria and study that proves the device meets specific performance criteria for AI/ML device evaluations as the prompt requests.
Instead, it pertains to sunlamp products and their compliance with electrical, mechanical, and radiation safety standards. Therefore, an AI/ML-specific response is not applicable to the content of this document.
However, I can extract the information relevant to the performance claims and testing described in the document, even though it's not related to AI/ML.
Here's an interpretation based on the document's content, focusing on the device's performance criteria as presented, and acknowledging that it's not an AI/ML device:
Device: KBL Sunlamp Products (various models: KBL 6800 alpha, KBL 7900 alpha, KBL 4800 alpha, KBL 5600 alpha, KBL Tower Space 2000, KBL Tower Space 3000, KBL Tower pureEnergy 5.0).
Intended Use: Over-the-counter tanning devices emitting ultraviolet light in the UVA and UVB region of the spectrum intended for tanning of the human skin of an adult person.
Acceptance Criteria and Reported Device Performance (Non-AI/ML)
| Acceptance Criteria Category | Acceptance Criteria Description (General) | Reported Device Performance / Compliance (Summary from document) |
|---|---|---|
| Biocompatibility | Device materials in contact with skin must be biocompatible. | Biocompatibility testing performed in accordance with DIN EN ISO 10993-1:2010-04, DIN EN ISO 10993-5:2009-10, and DIN EN ISO 10993-12:2012-10. (Implies compliance, but specific results or pass/fail thresholds are not detailed in this summary). |
| Electrical and Mechanical Safety | Device must meet relevant electrical and mechanical safety standards to ensure user safety. | Electrical and mechanical safety testing performed according to IEC 60601-1 Ed 3.1 2012/08 (IEC 60335-1:2010, 5th ed. and UL482:2005/09/02 Ed.9 Rev. 2013/10/03). (Implied compliance). |
| Electromagnetic Compatibility (EMC) | Device must not interfere with or be affected by other electronic devices. | Electromagnetic compatibility testing performed in compliance with IEC 60601-1-2:2007, modified. (Implied compliance). |
| Spectral Emission | The UV light emitted must be within specific spectral ranges (UVA and UVB) and power levels. | Spectral emission measurement based on the test procedure for measuring the spectral emission in accordance with IEC 60335-2-27:2009, 5th ed. (Implied compliance with the standard's requirements for spectral emission). |
| Software Verification and Validation | Any embedded software must be verified and validated for correct and safe operation. | Software verification and validation testing performed according to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Implied compliance). |
| Performance Standards (FDA 21 CFR 1040.20) | Compliance with general performance standards for sunlamp products, including irradiance and timer limits. | Performance Standards testing performed in accordance with 21 CFR 1040.20. Irradiance ratio limits are in accordance with 21 CFR 1040.20(c)(1). Maximum timer intervals and exposure schedules have been determined according to FDA's "Policy on maximum timer interval and exposure schedule for sunlamp products." (Implied compliance with all listed regulations and policies). |
Since this document describes a sunlamp product and not an AI/ML device, the following points from the prompt are not applicable:
- Sample sizes used for the test set and the data provenance: Not applicable to non-AI/ML device testing as described. The testing refers to engineering and regulatory standards for safety and performance of the physical device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model's classification or prediction is not relevant here.
- Adjudication method for the test set: Not applicable.
- 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 assesses human performance with AI assistance, which is for AI/ML devices.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the engineering and regulatory compliance testing cited.
- The sample size for the training set: Not applicable. This is for AI/ML model development.
- How the ground truth for the training set was established: Not applicable. This is for AI/ML model development.
§ 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.