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The Procera Implant Bridge Zirconia is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

In addition to Nobel Biocare implant systems, the Procera Implant Bridge Zirconia can be used on the following implant systems:

• Straumann Dental Implant System Regular Neck 4.8
• Straumann Dental Implant System Wide Neck 6.5
• 31 3.75
• Lifecore Biomedical Restore 3.75
• Zimmer Dental Taper-Lock 4.0
• Sterngold Implamed 3.75

Procera® Implant Bridge Zirconia is a dental prosthetic framework milled from one solid piece of Zirconia (zirconium oxide). The many endosseous implant interfaces that can be used in the Procers" implant Bridge Zirconia are precision milled and are an integral part of the framework.

The Procera® Implant Bridge Zirconia can be precision milled for two (2) to eight (8) units. The bridge is to function as a load-bearing device for implant-anchored prosthetics.

The Procera® Implant Bridge Zirconia is a packaged as a semi-finished, non-sterile, device and delivered to the dental laboratory for veneering and completion. The final, veneered, Procera® Implomation and colle Zirconia is delivered from the dental laboratory to the clinician.

This request cannot be fulfilled due to the nature of the provided document. The document is an FDA 510(k) summary for a dental prosthetic framework (Procera® Implant Bridge Zirconia). It describes the device, its indications for use, and confirms its substantial equivalence to predicate devices.

However, the 510(k) summary does not contain any information about clinical studies, acceptance criteria, or performance data that would be required to answer the specific questions posed, such as:

• Acceptance criteria and reported device performance: This document doesn't present a table of such.
• Sample size and data provenance for a test set: No test set is mentioned.
• Number of experts and their qualifications for ground truth: No expert review for ground truth is mentioned.
• Adjudication method: Not applicable as no ground truth establishment is described.
• MRMC comparative effectiveness study: No such study is mentioned.
• Standalone algorithm performance: This is a physical dental device, not an algorithm.
• Type of ground truth used: Not applicable for a device of this nature in this document.
• Sample size for training set/How ground truth for training set was established: Not applicable for a physical device.

The 510(k) process for devices like this primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, often through engineering analysis, material testing, and similarity in design and intended use, rather than clinical efficacy studies with specific performance metrics and ground truth as would be seen for, for example, diagnostic AI devices.

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