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For use in selected fully edentulous and partially edentulous arches

The additional components provided for by this 510(k) added to the fixtures, abutments and other components necessary to meet various clinical situations in partially and totally edentulous patients. All implants are root-form uncoated screws and are made from commercially pure titanium. The indications and uses for these additional components are not different from similar components of the predicate device. The application also provides for the use of the Single Tooth Implant System in multiple construction clinical situations.

This submission (K990304) is for additional components (abutments and fixtures) for an existing dental implant system, not a device that would typically have performance criteria measured by a clinical study with specific metrics like sensitivity, specificity, or accuracy. The FDA's review for this type of device focuses primarily on substantial equivalence to a predicate device, material safety, and mechanical integrity rather than diagnostic accuracy or clinical outcomes in the same way an AI/ML device would.

Therefore, the requested information regarding acceptance criteria, study details, expert review, MRMC studies, standalone performance, and ground truth for training and test sets is not applicable to this 510(k) submission.

This submission is a traditional 510(k) for an updated version of a previously approved device (K931767), comprising a list of components made of a known material (commercially pure titanium). The "acceptance criteria" in this context would revolve around demonstrating that the new components meet the same performance standards (e.g., mechanical strength, biocompatibility) as the predicate device and do not introduce new safety or effectiveness concerns. These kinds of evaluations are typically done through bench testing (e.g., fatigue testing, force retention, material characterization) rather than efficacy studies involving patient data and diagnostic performance metrics.

The documentation provided indicates that the "indications and uses for these additional components are not different from similar components of the predicate device." This suggests the primary "study" supporting the submission would be a demonstration of equivalence to the predicate, likely through design comparisons and perhaps limited bench testing for mechanical properties if the design significantly changed from the predicate.

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