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For use as an intra-bony, supporting component in the oral cavity to support crowns, bridges, and overdentures when replacing missing teeth.

4.0mm Simpler One Pushin Dental Implant

This document is a 510(k) clearance letter from the FDA for a dental implant and does not contain detailed information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Information about experts used for ground truth or adjudication methods.
4. Details of a multi-reader multi-case comparative effectiveness study or an effect size.
5. Results of a standalone algorithm performance study.
6. The type of ground truth used.
7. Sample size for the training set or how ground truth for the training set was established.

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