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Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.

The Straumann 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 device covered in this submission is an abutment.

The basal portion of the abutment has an inset octagonal design. 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 screwretained restorations.

The provided text is a 510(k) summary for a dental abutment (WN synOcta® Gold Abutment) seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by showing similar technological characteristics and intended use.

Crucially, the provided text DOES NOT contain information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement in the context of a performance study for this device.

The document details:

• Applicant and device information
• Predicate device identification
• Description of the device
• Intended use
• Basis for substantial equivalence (claiming identical intended use, material composition, basic design, and fundamental operating principles to the predicate).

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and study details because this information is not present in the provided text.

This 510(k) summary is a regulatory document affirming equivalence, not a detailed report of a performance study with specific metrics, thresholds, and statistical analyses that would typically be associated with AI/software devices or more complex medical devices requiring extensive new performance data. For a dental abutment, equivalence is often established through material testing, design comparisons, and sometimes mechanical testing, rather than studies involving human readers or extensive clinical outcome ground truth.

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