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Source of illumination for curing photo-activated, visible light cured dental restorative materials.

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This document is a 510(k) clearance letter from the FDA for a dental curing light, not a study report or a document detailing acceptance criteria and performance data for a device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, and does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
6. Results of a standalone algorithm performance study.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document is a formal communication from the FDA granting market clearance, not a technical report or clinical study summary.

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