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Nobel Biocare's Procera Titanium Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Procera Titanium Abutments fit the following endosseous implants:

• AstraTech 3.5, 4.0, 4.5, 5.0 mm

• Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm

Nobel Biocare's Procera Titanium Abutment for AstraTech and Camlog Implant Systems is fabricated to the exact shape, size, and specifications determined in the design process in order to achieve a personalized device that fits precisely, and properly functions, according to each patient's individual needs.

Nobel Biocare's Procera Titanium Abutment for AstraTech and Camlog Implant Systems is similar in design, intended use, and operation to the abutments cleared in predicate devices.

The provided text (K061478) is a 510(k) summary for a medical device called "Procera Titanium Abutment for AstraTech and Camlog Implant Systems." This document describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) submission process for this type of device typically relies on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics but no new questions of safety and effectiveness are raised. It does not generally involve a new clinical study with acceptance criteria in the same way an AI/ML device would.

Therefore, I cannot provide the requested information based on the provided text. The tables and study details you've asked for (such as sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) are typically associated with performance evaluations of AI/ML-driven devices, which this dental implant abutment is not.

The document essentially states that the device is similar in design, intended use, and operation to previously cleared abutments and is therefore substantially equivalent.

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