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INDICATIONS : Class V cavities (particularly erosion lesions). Class III cavities. Posterior cavities in deciduous teeth. 'Sticky' pits and fissures. Free-hand veneering.

For use only by dental professional such as DDS or DMD. Not for use by general public or OTC. Labels will bear this caution.

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This document is a 510(k) clearance letter from the FDA for a dental cement product. It is a regulatory approval document and does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML device.

The questions you've asked are typically relevant to the evaluation of AI/ML-driven medical devices, where performance metrics like sensitivity, specificity, or AUC are critical and established through rigorous studies.

This document, however, pertains to a traditional medical device (dental cement) where "performance" is assessed through different means, often involving material properties and clinical experience, not through the kind of statistical analysis of a test set with ground truth that your questions imply.

Therefore, I cannot provide answers to your specific questions based on the provided text.

Ask a specific question about this device