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Premium Plus C01/C02 Dental Curing Light is intended for use by trained dental professionals for the purpose of curing dental composites by light.

Premium Plus C01/C02 LED Curing Light is classified as an Ultraviolet Activator for Polymerization (21 CFR 872.6070) because it is used for polymerization of dental light cured materials by dental professionals. The device is based on blue LED (light emitting diode) technology. It has three curing modes. Using different modes gives dental professionals the flexibility to polymerize virtually almost all types of composites, boding agents and sealants available in the market.

Premium Plus C01/C02 LED Curing Light consists of a handpiece and a charging station, which is connected via a plug-in transformer to an AC outlet for charging. The handpiece contains high intensity dental blue LED light source and a fibre optic light guide(C01-1) that conduct light to the treatment area on the patients or direct light source head(C02-1). A protective light shield and transformer are accessories provided with Premium Plus C01/C02 LED Curing Light, which support the operation of the device. The protective light shield filters blue light to protect eyes of dental professionals and patients. An FDA cleared barrier sleeves must be used between each patient such as the Pac-Dent Barrier Sleeve.

This document is a 510(k) premarket notification for a dental curing light, the Premium Plus C01/C02 LED Curing Light. It aims to establish substantial equivalence to existing predicate devices. The information provided focuses on technical specifications and safety standards rather than clinical performance or AI algorithm validation.

Therefore, many of the requested details, such as acceptance criteria based on clinical metrics (e.g., sensitivity, specificity), sample size for test sets, ground truth establishment by experts, adjudication methods, or effects of AI assistance, are not applicable or not available in this document.

The document primarily relies on comparisons of technical characteristics and adherence to recognized safety and performance standards to demonstrate substantial equivalence.

Here's a breakdown of the available and unavailable information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, or human improvement with AI). Instead, it relies on demonstrating that the device meets recognized industry standards and performs comparably to predicate devices based on technical specifications and safety tests.

Therefore, instead of a clinical performance table, below are the relevant technical and safety performance criteria that were met:

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

• Sample Size for Test Set: Not specified for any clinical or performance comparison study. The document refers to "Performance Tests" for Electrical Safety, EMI, LED lamps, and Depth of Cure, but the number of units or materials tested is not mentioned.
• Data Provenance: Not applicable as there's no patient data or clinical imagery discussed. All testing appears to be laboratory-based and related to device specifications and safety.

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

Not applicable. The "ground truth" here is adherence to technical standards and specifications, not clinical diagnoses or interpretations. These standards are established by regulatory bodies and consensus organizations, not individual experts in a test set.

4. Adjudication Method for the Test Set

Not applicable. There's no interpretive task that would require 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

Not applicable. This device is a dental curing light, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device does not involve an algorithm for standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's approval is based on:

• Compliance with recognized international and national standards: IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility), ISO 10650-2 / ANSI/ADA Specification No. 48-2 (LED Curing Lights).
• Demonstrated technical equivalence in key specifications (intended use, light source, wavelength, radiant intensity, operational modes, power, environmental factors, safety standards) to already approved predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

Not applicable. There is no training set for this device.

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