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-For light activated polymerization of dental materials such as composites, luting cements. and sealants using visible light.
-For intraoral illumination used upon initial examination of the dental transillumination to help locate crown fractures, posterior and anterior caries, and for use as an auxiliary light source for endodontic procedures.

The proposed SmartLite®Pro Modular LED Curing Light is a cordless pen-style, LED light polymerization and illumination device for use by dental professionals in dental offices or dental laboratories.

This document is a 510(k) summary for the "SmartLite®Pro Modular LED Curing Light," which explicitly states that no clinical performance data has been included. Therefore, it is not possible to describe acceptance criteria or a study proving device performance in the context of human clinical data or AI performance metrics.

However, the document does list Non-Clinical Performance Data and outlines various tests conducted to support substantial equivalence. I can present the information related to the engineering and safety performance of the device based on the provided text.

Here's a breakdown of the non-clinical performance data and related information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Since detailed numerical acceptance criteria and specific reported performance values are not provided in a comparative table for each test, I will infer what "acceptance criteria" likely refers to (e.g., meeting a standard's requirements or conforming to an internal method) and list the tests that were performed to demonstrate that the device met these criteria.

The following sections are NOT applicable based on the provided document, as it explicitly states NO clinical data was included and does not pertain to AI/machine learning medical devices.

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

• Not applicable for clinical studies.
• For non-clinical bench testing, specific sample sizes for each test are not provided. The data provenance would be internal Dentsply Sirona laboratories, presumably in the USA (where the company address is listed for the submission).

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

• Not applicable for clinical studies.
• For non-clinical testing, ground truth is established by standardized methods (e.g., ISO standards) or internal engineering specifications, not by human experts in the way clinical ground truth is established.

4. Adjudication Method for the Test Set

• Not applicable for clinical studies.
• Not relevant for non-clinical bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI Assistance

• No, this is not an AI/machine learning device. This is a dental curing light/illuminator.
• Therefore, an MRMC study and AI assistance effect size are not applicable.

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

• No, this is not an AI/machine learning device. This is a dental curing light/illuminator.
• Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Not applicable for clinical ground truth.
• For non-clinical testing, the "ground truth" is typically defined by the specified requirements of the relevant IEC/ISO standards or the internal design specifications of the device.

8. The Sample Size for the Training Set

• Not applicable. This device does not employ machine learning and therefore has no training set.

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

• Not applicable. This device does not employ machine learning and therefore has no training set or associated ground truth establishment method.

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