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The Sunrise Curing Lamp is indicated for use in curing of composite resin materials for restoration of cavity preparation, curing of bonding materials, and any application where a conventional halogen curing lamp would be used.

The Sunrise Curing Lamp is a high intensity light source that is filtered and transmitted through a liquid optical fiber to the tooth for curing of composite resins.

The provided text describes a 510(k) submission for the Sunrise Curing Lamp, comparing it to a predicate device, the ADT 1000 Plasma Arc Curing System. However, the information provided focuses on technical specifications and substantial equivalence, not on the performance of the device against specific acceptance criteria in a clinical study as would be expected for a diagnostic AI/ML device.

Therefore, many of the requested items cannot be extracted directly from this document.

Here's an analysis based on the provided text, highlighting what is present and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance

Explanation of Inferred Criteria:
The document states, "Based on the favorable comparison of the technical performance specifications of the Sunrise Curing Lamp with the ADT 1000 Plasma Arc Curing Lamp, the company concludes that these substantially equivalent devices are safe and effective." This implies that the technical specifications of the predicate device serve as the de facto acceptance criteria for the new device. The Sunrise Curing Lamp's reported performance falls within or is comparable to these specifications, supporting its claim of substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. This document describes a medical device (curing lamp), not a diagnostic AI/ML system that would typically undergo a study with a test set of data. The "study" here is a comparison of technical specifications to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. No ground truth establishment by experts is mentioned, as this is a technical equivalence submission for a physical device.

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

• Not applicable / Not provided.

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

• No. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant to this submission.

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

• Not applicable / Not provided. This is not an algorithm.

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

• Not applicable / Not provided. For this type of device, the "ground truth" for proving effectiveness would likely involve material science testing on cured composite resins (e.g., hardness, bond strength) rather than clinical outcomes or diagnostic accuracy. However, this document relies on substantial equivalence to a predicate device based on technical specifications.

8. The sample size for the training set

• Not applicable / Not provided. No training set is mentioned as this is not an AI/ML device.

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

• Not applicable / Not provided. No training set ground truth is mentioned.

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