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Nobel Biocare's NOBELREPLACE® Adapter is a bushing that enables seating of a smaller diameter abutment to a larger diameter endosseous implant in an implant-supported dental restoration of a partially or fully edentulous jaw in order to restore patient esthetics and chewing function.

Nobel Biocare's NOBELREPLACE® Adapter is a hollow titanium alloy device intended for use as an accessory component designed to adapt a smaller platform abutment to a larger platform endosseous implant to a within the implant/abutment system. The NOBELREPLACE® Adapter provides a gradual transition from abutment to implant, and can only be used as part of the implant/abutment system, not on its own. It is designed to remain a component of the implant/abutment system for as long as the implant remains in the patient's mouth.

The provided text describes a 510(k) submission for the NOBELREPLACE® Adapter, a dental device. However, it does not contain any information regarding specific acceptance criteria, performance studies, or clinical trials. The document primarily focuses on establishing substantial equivalence to predicate devices based on design and intended use.

Therefore, I cannot provide the requested information. The text does not include:

1. A table of acceptance criteria and reported device performance: No performance data is presented.
2. Sample size used for the test set and data provenance: No test set or study is described.
3. Number of experts used to establish ground truth and their qualifications: No ground truth establishment is mentioned.
4. Adjudication method: Not applicable as no study is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
6. Standalone (algorithm-only) performance: Not applicable as this is a physical dental device, not an AI algorithm.
7. Type of ground truth used: Not applicable as no study data is presented.
8. Sample size for the training set: Not applicable as this is not a machine learning device.
9. How ground truth for the training set was established: Not applicable.

The document states that the NOBELREPLACE® Adapter is a hollow titanium alloy device used to adapt a smaller platform abutment to a larger platform endosseous implant. The 510(k) submission focuses on comparing its attributes and intended use to existing legally marketed devices (Replace Scalloped Margin Implant System and Nobel Biocare Permanent Centric Post) to demonstrate substantial equivalence, rather than presenting results from a performance study against acceptance criteria.

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