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XR Primer 2 is a light-cured cavity primer used to wet the interior of a prepared cavity of a tooth prior to application of an adhesive to improve retention of a restoration.

XR Primer 2 is a light-cured cavity primer used to wet the interior of a prepared cavity of a tooth prior to application of an adhesive to improve retention of a restoration.

This document is a 510(k) summary for the XR Primer 2, a light-cured cavity primer. It does not contain information about acceptance criteria or a study proving that a device meets such criteria.

The document primarily focuses on establishing substantial equivalence for the XR Primer 2 to a legally marketed predicate device (the original XR Primer formulation). This type of submission to the FDA (510(k)) generally relies on demonstrating that a new device is as safe and effective as a predicate device, rather than requiring extensive clinical trials to establish new performance metrics against pre-defined acceptance criteria.

Therefore, I cannot extract the requested information from the provided text regarding:

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 for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study or related effect size.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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