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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.

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 abutments.

The basal portion of the abutment has 4 protrusions diametrically opposed that engage in the 4 grooves of the P.004 implant. The abutment is seated in the implant with a screw which is mounted in the basal portion of the abutment. The abutment is used for cemented and screw-retained restorations.

This documentation describes a 510(k) premarket notification for a dental abutment, P.004 RC Gold Abutment. It explicitly states that the device is substantially equivalent to a predicate device and notes it has the same material composition, basic design, and fundamental operating principles.

Therefore, the document does not contain information related to acceptance criteria, device performance testing, or studies involving AI/ML, human readers, or ground truth establishment. The FDA's 510(k) clearance process for this type of device primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than requiring extensive performance studies as might be seen for novel devices or software with AI/ML components.

To directly answer your request based on the provided text, I must state that the requested information (items 1-9) about acceptance criteria and device performance studies is not present in the provided 510(k) summary. This document details a traditional medical device submission (dental abutment), not a software or AI/ML device submission.

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