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Source of illumination for curing photo-activated dental restorative materials and adhesives.

Valo™ is an activator, ultraviolet for polymerization. In other words, it is a dental curing light used for polymerization of all photo-mitiated dental materials.

The provided text is a 510(k) premarket notification for a dental curing light called Valo™. It describes the device, its indications for use, and claims substantial equivalence to a predicate device (Palmlight). However, it does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance.

The document is a declaration of substantial equivalence based on the device being similar to an already legally marketed device, not a report of a new clinical or performance study with defined acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory filing stating that the Valo™ device is an ultraviolet activator for polymerization, intended as a source of illumination for curing photo-activated dental restorative materials and adhesives, and that it is substantially equivalent to a predicate device. It does not include the detailed performance study information you are asking for.

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