(373 days)
The device is intended to be used for the tanning of Human Skin.
The IBL 5000 tanning booth is available in two configurations, a 200W configuration that utilizes 79 inch fluorescent UV lamps and a 160W configuration that utilizes 71 inch fluorescent UV lamps. Each configuration consists of a metal structure with 50 lamps vertically arranged in a manner that surrounds the tanner so as to provide a consistent all around tan. The user stands in the center of the booth. Double doors allow entry and exit from the booth. The lamps are powered by inductive (choke) type ballasts. The duration of exposure is controlled by a user settable electronic timer. The session time can be set to any value called for on the recommended exposure schedule. Session time cannot be set longer than the maximum recommended exposure schedule time. A backup timer is provided that ensures the booth's lamps cannot operate longer than the maximum recommended exposure. A stop switch is provided within the tanning area to immediately turn off the UV lamps if needed.
The dosage of UV irradiation is within allowable limits set by the FDA performance standard 21 CFR 1040.20 and FDA Guidance letter dated August 21st 1986 titled Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products.
The document provided is a 510(k) summary for the IBL 5000 Tanning Booth and does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.
The information requested, such as specific performance metrics like sensitivity, specificity, or AUC, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is typically found in submissions for AI/ML diagnostic or assistive devices.
The IBL 5000 Tanning Booth is classified as a Class II device (Ultraviolet lamp for tanning, 21 CFR 878.4635, Product Code: LEJ). The regulatory submission focuses on demonstrating substantial equivalence to a predicate device by adhering to established performance standards for sunlamp products, primarily concerning UV irradiation dosage and safety features.
Here's an analysis of the provided text based on the request, highlighting why some information is not present for this type of device:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in the typical format of an AI/ML device (e.g., minimum sensitivity/specificity thresholds). Instead, the performance criteria are related to safety and compliance with existing regulations for tanning devices. The "performance" reported is adherence to these standards.
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance |
|---|---|
| Dosage of UV irradiation within allowable limits set by FDA performance standard 21 CFR 1040.20 and FDA Guidance letter dated August 21st 1986. | "Results of the UV irradiance testing performed on both configurations confirm that the dosage is within allowable limits set by the FDA performance standard 21 CFR 1040.20 and FDA Guidance letter dated August 21st 1986 titled Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products." |
| Compliance with 21 CFR 1040.20 (Performance Standard for Sunlamp Products). | Confirmed by UV irradiance testing. |
| Compliance with FDA Guidance letter dated August 21st 1986 (Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products). | Confirmed by UV irradiance testing. |
| Reliability and safety of Timer Software. | "Timer Software Validation and Verification" was performed. Results demonstrated the device met acceptance criteria. |
| Biocompatibility of surfaces in contact with the tanner. | "Biocompatibility of surfaces in contact with the tanner" was evaluated. Results demonstrated the device met acceptance criteria. |
| Electromagnetic compatibility and electrical safety. | "Electromagnetic compatibility and electrical safety" was evaluated. Results demonstrated the device met acceptance criteria. |
| Temperature of contact surfaces and air within tanning booth during operation. | "Temperature of contact surfaces and temperature of air within tanning booth during operation" was evaluated. Results demonstrated the device met acceptance criteria. |
| Labeling compliance with 21 CFR 1040.20 and 21 CFR 878.4635. | "Device labeling and user manual contraindications and warnings for both configurations are in compliance with the requirements of 21 CFR 1040.20 and have been updated to comply with the recently updated regulation 21 CFR 878.4635." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and therefore not provided in the document. The "testing" involved physical measurements and evaluations of the device's components and operations (e.g., UV irradiance, timer function, electrical safety, thermodynamics, biocompatibility) rather than a study with a test set of data (like images or patient records) that would have provenance.
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)
This information is not applicable. "Ground truth" in the context of expert consensus is relevant for diagnostic devices that make predictions or classifications, not for a tanning booth which is evaluated against engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated above.
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
This information is not applicable. The device is not an AI/ML diagnostic or assistive tool, and therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical product (tanning booth) and does not involve an algorithm for diagnosis or decision-making.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's evaluation is based on established regulatory standards and guidance documents (e.g., 21 CFR 1040.20, FDA Guidance letter dated August 21st, 1986) related to UV radiation dosage, safety features, and labeling requirements for sunlamp products. These are objective engineering and performance criteria, not based on expert consensus for interpreting medical data.
8. The sample size for the training set
This information is not applicable. The device is not an AI/ML product developed using training data.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
§ 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.