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TempBond Clear with Triclosan is a dual-cured, temporary, eugenol-free, transparent, resin-based cernent with triclosan designed to be used in conjunction with temporary restorations such as crowns, bridges, inlays, onlays and splints.

TempBond Clear with Triclosan is a dual-cured, temporary, eugenol-free, resin-based cement with triclosan. This base/catalyst cement is flexible and transparent when cured. The device will be packaged in a dual-barrel syringe to eliminate hand mixing. It has excellent flow to permit the restoration to be easily and completely seated. It is strong enough to withstand the stresses of mastication, yet permits easy removal of the restoration when it is desired. TempBond Clear with Triclosan contains triclosan.

The provided text does not contain any information about acceptance criteria or a study proving device performance in the context of AI/ML or comparative effectiveness.

This document is a 510(k) premarket notification for a dental product called "TempBond Clear with Triclosan." It describes the device, its intended use, and claims substantial equivalence to another legally marketed device (Kerr Corporation, TempBond Clear). The FDA letter confirms the substantial equivalence determination.

Therefore, I cannot fulfill your request for the following reasons:

• No acceptance criteria: The document does not define any specific acceptance criteria for performance metrics (like sensitivity, specificity, or accuracy) that would be relevant for an AI/ML device.
• No study to prove device meets acceptance criteria: There is no study described that evaluates the performance of "TempBond Clear with Triclosan" against any set criteria. The approval is based on substantial equivalence to a predicate device, not on direct performance testing against clinical endpoints or statistical metrics relevant to AI.
• No information on AI/ML components: The device described is a dental cement, not an AI-powered diagnostic or therapeutic tool. Therefore, concepts like sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are irrelevant to this submission.

In summary, the provided text is a regulatory submission for a conventional medical device (dental cement) and does not involve AI/ML or the types of performance studies you've inquired about.

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