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The Ultrasonic Tips with Diamond Coating are utilized in endodontic root preparation procedures which includes retro-prep of root ends in order to make space for permanent filling material in the canal.

The Ultrasonic Tips with Diamond Coating are utilized in endodontic root preparation procedures which includes retro-prep of root ends in order to make space for permanent filling material in the canal. The tips are composed of stainless steel with a layer of fine diamond particles.

This document is a 510(k) summary for the Sybron Dental Specialties, Inc. Ultrasonic Tips with Diamond Coating. This type of regulatory submissiondoes not include detailed performance studies or acceptance criteria tables like those found for software or AI/ML devices.

The content focuses on demonstrating "substantial equivalence" to a predicate device, which means the new device is as safe and effective as a legally marketed device. This is typically achieved by showing similar intended use, technological characteristics, and performance characteristics (though often not quantified in the same way as for advanced software).

Therefore, I cannot provide the requested information because it is not present in the provided text. Specifically:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission states the device "functions in a manner similar to and is intended for the same use" as a predicate device, which is the basis for substantial equivalence, not specific performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of performance metrics for an AI/ML device is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. There is no mention of a ground truth establishment by experts for performance evaluation.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This is a physical medical device (ultrasonic tips), not a software algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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