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Intended for use by dentists to give retention for reconstruction of endontically treated teeth.

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I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a dental device (FRC Postec Plus) and primarily focuses on regulatory approval based on substantial equivalence to a predicate device. It does not detail specific performance acceptance criteria or the study design and results as requested in your prompt.

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FRC Postec is intended for use by dentists to give retention for reconstruction of endontically treated teeth

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The provided text is a 510(k) premarket notification letter from the FDA to Ivoclar Vivadent, Incorporated for their device, FRC POSTEC. This document is related to the regulatory approval of a medical device, specifically a root canal post, and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This type of regulatory submission (510(k)) focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies that define and meet specific acceptance criteria in the manner expected for new, novel devices or those undergoing a PMA (Premarket Approval) process.

Therefore, I cannot provide the requested information from the given text. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Information about MRMC comparative effectiveness studies.
6. Details of 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 approval letter based on substantial equivalence, not a detailed technical report or study protocol.

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