(247 days)
The intended use of the T-Series tanning beds and booth is solely for the tanning of the human skin.
The T-Series tanning beds and booth are devices that omit ultraviolet radiation in the UVA and UVB range to produce a cosmetic tan. The T-Series family of units is made up of five (5) lay-down beds and one (1) stand-up unit. All the lay-down beds in the T-Series are similar in design. They are made up of 3 sections, a canopy or top section (tans the front side of the user), a base or bed section (tans the back side of the user) and a side console (made up of cooling fans and controls). The beds are all 87" long and vary in width from 35 inches to 59 inches. The main difference in the bed design between the five (5) models is the amount of ultraviolet sunlamps they are equipped with. The T-32 is equipped with 32 ultraviolet sunlamps. The T-40 is equipped with 40 ultraviolet sunlamps. The T-44 is equipped with 44 ultraviolet sunlamps. The T-52 is equipped with 52 ultraviolet sunlamps. The T-72 is equipped with 64 ultraviolet sunlamps. The laydown beds are also designed to be equipped with optional face bulbs. The face bulbs are installed in the canopy section. Each unit can be outfitted with up to 3 face bulbs. The lay-down beds are constructed of the same materials. Their frames are made up of power coated steel, stainless steel and anodized aluminum. All the beds are equipped with an acrylic sheet in both the base and canopy sections. The acrylic sheet is designed specifically for the transmission of ultraviolet light in the UVA and UVB range. The acrylic sheets also server as a barrier to protect the user from lamp breakage and for sanitary purposes. The lay-down beds also share the exact same electrical components which mainly consist of a choke type ballast, starter and fluorescent sunlamp. The choke ballast acts like a valve and limits the amount of power/wattage to the lamp. The starter is needed in the initial start-up of the lamp; it generates an inductive kick which provides the high voltage needed to start the lamp. The fluorescent sunlamp is made specifically for tanning equipment. It is a low pressure mercury vapor gas-discharge lamp that emits most of its energy in the UVA and UVB range between 260nm-400nm. The ballast, starter and fluorescent sunlamp used in our lay-down beds are available in 100 Watt, 160 Watt or 200 Watt confiquration. The face bulbs are physically smaller than the fluorescent sunlamps and are made of a quartz glass. They also work with a ballast and starter system. The ballast, starter/ignitor and face bulb are 400 watts. The T-series booth (TT-50) is designed for a vertical application. It has the same metal construction as in the lay-down beds and also outfitted with the same electrical components. The booth is made up of 7 sections. One (1) floor platform which is made of stainless steel. Five (5) vertical columns, each equipped with ten (10) fluorescent sunlamps One (1) overhead section which consists of an 18 inch cooling fan and controls. Each sunlamp column is equipped with a powder coated steel grid to prevent the user from contacting the lamps. There handles attached to the overhead section in which the user can hold on to while tanning. The handles are made of steel and chromes plated. Face tanners are not available for the stand-up booth. Both our lay-down beds and stand-up unit are configured to work with a timer system to ensure than the users of the equipment do not overexpose themselves to the ultraviolet light. The T-Series tanning beds and booth require 220 volts AC.
This FDA 510(k) summary is for a medical device submission (tanning beds/booths), not an AI/ML powered device. Therefore, it does not contain the specific information requested about acceptance criteria and study designs that would typically be associated with performance evaluation of an AI/ML device.
The document primarily focuses on demonstrating substantial equivalence to a predicate device, which is a common pathway for medical device clearance. The "performance testing" described is related to electrical safety and photobiological safety standards for tanning equipment, not the performance of an algorithm.
Therefore, it is not possible to extract the requested information (acceptance criteria, device performance, sample sizes, ground truth details, MRMC studies, standalone performance) related to an AI/ML device from this document.
The "Conclusion" section clearly states that the device is substantially equivalent to its Class-I predicate models. This indicates that the evaluation was primarily against existing safety and efficacy standards for tanning beds, not an AI/ML performance evaluation.
§ 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.