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Intended to provide ultraviolet light to tan the skin.

The TanThera-T35 ("T35") is a tanning chamber employing UVA1 (340 nm - 400 nm) light-emitting diode ("LED") technology as the ultraviolet light source in order to provide a tanning response to human skin. It is designed in a clam-shell format with an upper ("canopy") and lower ("bench") radiant surface in order to provide a two-sided tan with a person in supine position on an acrylic platform. The principle parts of the T35 include multiple T35 LED Modules, forty-four (44) copper tube heat sink with a linear array of thirty-eight (38) T35 LED Modules each, a T-Max ® Timing System, a temperature control system, and a chilled-water liquid cooling system. The copper tube arrays with temperature equalizing internal counter-current flow dams, are arranged with twenty-six (26) tube arrays on the canopy and eighteen (18) tube arrays on the bench. The tube arrays are mounted behind a diffuse reflector that has cutouts for each of the T35 LED Modules. There is an acrylic shield between the tanner and the arrays to prevent tampering and contact with T35 LED Modules as well as to provide a minimum distance from the emitters to the tanner. The liquid cooling system has temperature and flow controls that sense and control water flow to maintain the LED modules at an operating temperature range. The bed is designed to terminate operation if the operating parameters of the T35 LED Modules are not met. Should the T35 LED Module temperature increase due to low coolant flow or high coolant inlet temperatures then the session terminates to prevent overheating and possible early burnout of the LED modules. A failure of the cooling system decreases LED lifetime but does not pose a significant risk to the tanner. The T35-LED Module is comprised of Nichia Chip-Type LEDs (Model NCSU033A), a power connector, a fuse, and a 700 mA nominal current regulator. The T35-LED Module (Model 3N33X1) is clearly marked with a recommended lifetime of 10,000 hours. The T35 is powered by low-voltage DC power (13 ± 0.5 VDC, 12 ± 0.1 VDC, - 12 ± 0.1 VDC) and low-voltage DC-DC converters located in the bench of the tanning chamber with redundant fans for cooling. T35 LED Modules are replaceable by TanThera certified technicians only. The T35 has a nominal peak wavelength output of 365nm and a maximum tanning session of 35 minutes. The total tanning chamber output less than 1250 W of UVA 1 light. An industry de-facto standard T-Max® timer regulates the session. The T35 incorporates a manual session termination switch that allows a tanner to discontinue a session at any time.

This 510(k) premarket notification for the TanThera-T35 UVA1 Light Emitting Diode Tanning Chamber does not contain a study that proves the device meets specific acceptance criteria in the way described in your request.

The submission is focused on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with defined acceptance criteria for a novel clinical outcome.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The submission aims to show equivalence based on existing standards for sunlamp products, not specific performance metrics against new acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

No test set or clinical study data is presented. The substantial equivalence argument relies on:

• Comparison with the Suntana SunSystem SunBed and SunBrella (for structural and operational equivalence).
• Comparison with the Philips TL10 UVA1 lamp (for spectral irradiance equivalence for effective tanning).

These are established products, not a "test set" in the context of a new clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. No ground truth was established by experts for a specific performance metric of the TanThera-T35, as there wasn't a clinical study presented.

4. Adjudication Method:

Not applicable. No adjudication method was used for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. No MRMC study was conducted or presented. The submission does not involve AI assistance or human reader performance.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This device is a tanning chamber, not an algorithm.

7. Type of Ground Truth Used:

Not applicable in the context of clinical performance. The "ground truth" for the substantial equivalence argument is the established safety and efficacy of the predicate devices (Suntana SunSystem and Philips TL10 UVA1 lamp) for providing UV light to tan the skin.

8. Sample Size for the Training Set:

Not applicable. This device is a physical product, not a machine learning algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an algorithm.

Summary of Device Acceptance/Equivalence:

Instead of a study proving specific acceptance criteria, the TanThera-T35 gained market clearance through a 510(k) Substantial Equivalence pathway. This means the FDA determined the device is as safe and effective as a legally marketed predicate device.

The basis for this determination was:

• Structural and Operational Equivalence: Compared to the Suntana SunSystem SunBed and SunBrella.
• Spectral Irradiance Equivalence (for effective tanning): Compared to the Philips TL10 UVA1 lamp.
• Adherence to Standards: The design references applicable parts of FDA documents "Sunlamp products and ultraviolet lamps intended for use in sunlamp products" (21 CFR 1040.20) and "GUIDE FOR PREPARING PRODUCT REPORTS ON SUNLAMPS AND SUNLAMP PRODUCTS (21 CFR 1002)".
• Technological Difference: The primary technological change is the use of LED technology instead of mercury vapor lamps. The submission argues this difference does not raise new questions of safety or efficacy, as the spectral output, mode of operation, and general operating principles are similar to or the same as the predicate devices.

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