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This product is intended for the exclusive purpose of cosmetic tanning of the human skin using light between 260-400nm.

Light Sources UV Lamps for Indoor Tanning devices are ultraviolet lamps that have the same basic technological features and the same intended use. The ultraviolet sunlamps in this submission are classified either as low pressure, or high pressure devices. The main difference for the various models of sunlamps in this submission are: lamp wattage, lamp length, lamp diameter, and spectral emissions. Light Sources UV Lamps for Indoor Tanning devices are ultraviolet sunlamps classified either as low pressure, or high pressure devices emitting light between 260- 400nm. The basic parts are as follows: Bases, Glass Bulb (envelope), Electrodes (Cathodes/Coils), Phosphor Coating, Reflector Coating, Mercury, Inert fill gases.

The provided documentation is a 510(k) summary for "UV Lamps for Indoor Tanning Devices". This document outlines the regulatory submission for a Class II medical device. However, it does not describe a study that uses a test set, ground truth established by experts, or any of the metrics requested for assessing device performance in the context of an AI/ML powered medical device.

The "performance data" section refers to compliance with established international consensus standards and FDA performance standards, primarily related to electrical safety and radiation limits for UV lamps. It does not mention any clinical study or evaluation of a medical device's diagnostic or predictive capabilities.

Therefore, I cannot provide the requested information for acceptance criteria and device performance based on the input text. The information is not present in the document.

Missing Information/Not Applicable Based on Document Content:

• Acceptance Criteria Table: The document does not specify performance metrics like sensitivity, specificity, accuracy, or AUC, nor does it list acceptance criteria for such metrics. The "performance data" refers to compliance with safety and radiation standards, not diagnostic or AI-related performance.
• Sample Size for Test Set and Data Provenance: No test set is described in the context of diagnostic or predictive performance.
• Number of Experts and Qualifications: No experts are mentioned in the context of establishing ground truth for a test set.
• Adjudication Method: Not applicable as there's no test set involving expert review.
• MRMC Comparative Effectiveness Study: Not applicable. The device is a UV lamp, not an AI-powered diagnostic tool.
• Standalone Performance: Not applicable. This refers to an AI algorithm's performance without human intervention; the device is a physical product.
• Type of Ground Truth: Not applicable. There is no diagnostic ground truth mentioned.
• Sample Size for Training Set: Not applicable. The device is not an AI/ML algorithm that requires a training set.
• How Ground Truth for Training Set was Established: Not applicable.

What the document does include regarding performance:

The device's "performance" is demonstrated through its compliance with established safety and performance standards for sunlamp products:

• INTERNATIONAL CONSENSUS STANDARDS:
  • IEC/EN 61195:2014 (Double Capped Fluorescent Lamps Safety Specifications)
  • IEC/EN 60355-2-27 (Household and Electrical Appliances Safety Requirements for Skin Exposure for UV and IR Radiation)
• FDA PERFORMANCE STANDARDS:
  • 21 CFR 1040.20 (Performance Standard For Sunlamp products and ultraviolet lamps intended for use in sunlamp products)
  • Specific performance testing (spectral analysis) data was submitted to ensure compliance with radiation limits set out in 21 CFR 1040.20.

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