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The Sunfire series of tanning beds is available in four configurations; a 32 lamp configuration that contains sixteen 71 inch fluorescent UV lamps in its canopy section and sixteen 71 inch fluorescent UV lamps in its bench sections, a 24 lamp configuration that contains twelve 71 inch fluorescent UV lamps in its canopy section and twelve 71 inch fluorescent UV lamps in its bench sections, a 16 lamp configuration that contains eight 71 inch fluorescent UV lamps in its canopy section and eight 71 inch fluorescent UV lamps in its bench sections, and a 12 lamp canopy only configuration that contains twelve 71 inch fluorescent UV lamps. Each configuration consists of a metal structure with lamps horizontally arranged in a manner so that they are equidistant from the tanner. The user of the Sunfire 32, 24 and 16 units lies down on the bench section and pulls down the canopy section, which is counterweighted by gas springs so that it can pivot and remain at any angle. The user of the Sunfire 12R lies down on a cot or bed and positions the Sunfire 12R canopy over their body. The lamps are powered by electronic type ballasts. The duration of exposure is controlled by a user settable electronic timer or alternatively an electromechanical 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 bed's lamps cannot operate longer than the maximum recommended exposure. A stop switch or knob is provided to immediately turn off the UV lamps if needed.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Sunfire 32, Sunfire 24, Sunfire 16, Sunfire 12R Tanning Beds/Canopies based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	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 all lamp 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." The results "provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use and performs comparably to the existing device."
Mechanical timer supplemented by a separate back-up timer to guard against failure of the main timer.	The current device incorporates "the mechanical timer is now supplemented by a separate back-up timer to guard against failure of the main timer."
Alternate electronic timer with a built-in back-up timer.	The current device incorporates "the alternate electronic timer has a built-in back-up timer."
Labeling, device labeling, and user manual contraindications and warnings in compliance with 21 CFR 1040.20 and updated to comply with 21 CFR 878.4635.	"Labeling, 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. See Proposed Labeling section of this submittal."
Timer Software Validation and Verification performed.	"Timer Software Validation and Verification" was tested and/or evaluated.
Biocompatibility of surfaces in contact with the tanner evaluated.	"Biocompatibility of surfaces in contact with the tanner" was tested and/or evaluated.
Electromagnetic compatibility and electrical safety evaluated.	"Electromagnetic compatibility and electrical safety" was tested and/or evaluated.
Temperature of contact surfaces and temperature of air within tanning booth during operation evaluated.	"Temperature of contact surfaces and temperature of air within tanning booth during operation" was tested and/or evaluated.
Equipment for home use has a disabled control system until a training program is completed. Training program covers specific topics (skin type, eyewear, age, skin lesions, skin cancer, tanning intervals).	"Home use tanning equipment sold by Sunfire will ship with its control system disabled, preventing the equipment's use until a training program is completed. The training program will cover...: 1. Use of the exposure schedule to correctly define skin type and choose the appropriate session time to avoid overexposure (sunburn). 2. Importance of wearing approved eyewear... 3. Contraindicated for people under 18 years old. 4. Contraindicated when skin lesions or open wounds are present. 5. Should not be used by those with skin cancer or have a family history of skin cancer. 6. Allow time between tanning sessions..."

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

The document does not explicitly state a sample size for a "test set" in the context of clinical trials or AI evaluation. The performance testing described sounds like product verification and validation for each device configuration.

Test Set: Not applicable in the context of typical AI algorithm testing. The testing was performed on "all lamp configurations" of the Sunfire 32, 24, 16, and 12R devices.
Data Provenance: The document does not specify country of origin for data. The testing described appears to be internal validation of the tanning bed's physical and functional specifications. It's an engineering and safety assessment rather than a data-driven clinical study. The submission is from Sunfire Industries Inc. based in New Bern, NC, USA. The predicate devices are also Sunfire Industries Inc. models.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not an AI/diagnostic device that relies on expert interpretation of data to establish ground truth. The "ground truth" here is the adherence to established performance standards and regulations (e.g., specific UV dosage limits, timer functionality, electrical safety).

4. Adjudication Method for the Test Set

Not applicable. There is no adjudicated "test set" in the sense of expert review of cases.

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. This device is a tanning bed, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not contain an AI algorithm in the traditional sense. The "algorithm" here would refer to the device's operational logic (timers, UV output control), which was tested to operate correctly "standalone" in verification tests.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" is based on regulatory performance standards and guidelines:

FDA performance standard 21 CFR 1040.20 (Sunlamp products).
FDA Guidance letter dated August 21st, 1986, titled "Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products."
21 CFR 878.4635 (Ultraviolet Lamp For Tanning regulation).
Electrical safety and biocompatibility standards (implied, though specific standards aren't listed beyond "compliance").

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set for an AI algorithm is mentioned or relevant for this device.

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