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Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations.

The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are anatomic abutments. Abutments are placed into dental implants to provide support for prosthetic restorations.

The provided text {0}-{4} does not contain information regarding acceptance criteria, device performance, or any studies in the context of AI/ML-based medical devices. Instead, it is a 510(k) summary for a dental abutment, establishing substantial equivalence to a predicate device.

Therefore, I cannot answer the questions about acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for either test or training sets. This information is not present in the provided document.

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