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The I Light intraoral curing light is designed to polymerize visible light cure (VLC) dental materials, including dental pit and fissure sealants, bonding adhesives, cements, restorative or luting materials.

The I Light is a LED curing light that is small, easy to use, and swift in curing. It has a compact, lightweight hand piece, with a curved and contoured tip, to allow the light to be positioned and applied anywhere in the oral cavity. It consists of a hand unit and a battery charger. The hand unit contains a programmed control circuit, high intensity dental blue LED light source, a light guide and an optical fiber that conducts light to the treatment area on the patient.

The provided text describes the 510(k) submission for the "I LIGHT Dental Curing Light". However, it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in the format requested.

The submission focuses on establishing substantial equivalence to predicate devices (SmartLite™ PS LED Curing Light and Elipar™ FreeLight) based on similar indications for use, technological features, and capabilities (LED activation for photopolymerization of camphorquinone-based visible light-cured dental resins and bleaching materials).

Here's an breakdown of the information that is available and what is missing based on your request:

1. Table of acceptance criteria and the reported device performance

• Missing. The document states that the I Light was "tested, and determined to be in conformance with, EN 60601/A2 of June 1995 and EN 60601-1-2 of November 2001." These are general safety and electromagnetic compatibility standards, not performance specifications with defined acceptance criteria for curing effectiveness (e.g., depth of cure, hardness, bond strength). The document asserts that the safety and effectiveness of such devices are "well established" due to the long market presence of predicate devices, implicitly suggesting the new device is expected to perform similarly without explicitly stating specific performance metrics or acceptance criteria for this device.

2. Sample size used for the test set and the data provenance

• Missing. No information on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Missing. No test set or ground truth establishment process is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Missing. No test set or adjudication method is described.

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

• Missing. This device is a dental curing light, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not applicable.

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

• Missing. This device is a physical dental curing light, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Missing. No formal ground truth for performance evaluation is described. The basis for substantial equivalence is primarily technological similarity and intended use, not clinical outcomes data from a specific study on the I LIGHT device.

8. The sample size for the training set

• Missing. No training set is applicable for this type of device.

9. How the ground truth for the training set was established

• Missing. No training set is applicable for this type of device.

Summary of Available Information:

The document primarily relies on the concept of substantial equivalence to existing predicate devices. It states: "The I Light and its predicate devices are similar electromedical devices in that have nearly identical indications for use and have similar technological features and capabilities. The I Light and its predicate devices all utilize the same technology -- LED activation to cause photopolymerization of camphorquinone-based visible light cured (VLC) dental resins and bleaching materials. The devices are substantially equivalent in intended use, operation, wavelength range, and light source."

Non-clinical tests performed were for conformance to general safety and electromagnetic compatibility standards (EN 60601/A2 and EN 60601-1-2), not specific performance criteria related to curing efficacy.

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