(64 days)
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.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.