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The Suncapsule Tanning Booth devices (All Models) are intended to provide ultraviolet light exposure to male and female users over the age of 18 years to produce a tanning response in the skin.

All Sun Capsule models are stand up booths utilizing UV fluorescent lamps arranged on upright walls in a hexagon pattern. Some models also include an optional changing booth. Standard industry construction materials are used including steel trusses, particle board, lighting components, pop rivets, etc. There are no unique materials other than the lamps which use length and diameter combinations that are unique to the tanning industry and not used for general lighting.

The number, length, and operating parameters of the lamps of each model differ in order to shorten or lengthen the exposure time desired by the purchaser. Each of the six walls constitutes a lighting fixture containing the lamps, sockets, ballast, wire, connectors and components associated with the lamp sizes required for the particular model. There are no other differences between the models.

A digital control timer module is used to program exposure times and the booths are utilized only with included protective eyewear, as outlined in 21 CFR 1040.20 (c).

This document is a 510(k) summary for a medical device called "Suncapsule Tanning Booth Devices (All Models)". This device is an ultraviolet lamp for tanning, classified as Class II. The document details the device, its intended use, and its substantial equivalence to predicate devices.

Here's an analysis of the provided text, particularly focusing on the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "Specific performance testing (spectral analysis) data is submitted in this application for each device that measured irradiance to ensure compliance with radiation limits set out in 21 CFR 1040.20."

• Test Set Sample Size: The term "each device" implies that each model of the Sun Capsule Tanning Booth Devices underwent testing to measure irradiance. The specific number of individual units tested for each model is not provided.
• Data Provenance: Not explicitly stated as retrospective or prospective, or country of origin. However, the testing was conducted by the manufacturer to demonstrate compliance with national and international standards, suggesting it was an internal validation effort.

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

This information is not provided in the document. The device's performance is measured against engineering and regulatory standards (e.g., IEC, UL, 21 CFR 1040.20), not against a human-established ground truth like expert consensus on medical images.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The performance criteria are objective measurements against established engineering and regulatory standards, not subjective interpretations requiring adjudication.

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

There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers in this document. This device is a tanning booth, not an AI-powered diagnostic or assistive tool.

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

This information is not applicable/provided. The device is a physical product (tanning booth) and its performance is measured based on its physical properties and emissions, not an algorithm's standalone performance.

7. The Type of Ground Truth Used

The ground truth used for this device's acceptance is based on:

• Established national and international consensus standards: IEC/EN 60601-1, IEC 60601-1-2, UL 482.
• FDA performance standards: 21 CFR 1040.20, specifically for radiation limits and irradiance measurements.

8. The Sample Size for the Training Set

This information is not applicable/provided. This device is not an AI/ML model that requires a training set. Its performance is based on engineering and design specifications and physical testing.

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

This information is not applicable/provided as there is no training set for this type of device.

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