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Nobel Biocare's Procera Bridge Zirconia is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera Bridge Zirconia may be cemented or bonded to either natural or artificial tooth abutments.

Nobel Biocare's Procera Bridge Zirconia is a prefabricated device intended for use as the core structure of an artificial prosthesis for placement in the oral cavity in order to restore chewing function. The Procera Bridge Zirconia is precision milled from one solid piece of densely sintered Zirconia, and can be cemented or bonded to either natural or artificial tooth abutments.

The provided text is a 510(k) summary for the Nobel Biocare Procera Bridge Zirconia device. It primarily focuses on the device description, indications for use, and regulatory classification, stating its substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation reports or performance studies. The 510(k) process for this type of device (a Class II Porcelain Tooth) largely relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than on generating new clinical performance data with specific acceptance criteria.

Therefore, for your request, I must report that the requested information is not available within the provided text. The document is a regulatory submission for premarket notification, not a performance study report.

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Nobel Biocare's Procera® Bridge Zirconia is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera® Bridge Zirconia may consist of two to eights units and is cemented to natural or artificial tooth abutments.

Nobel Biocare's Procera® Bridge Zirconia is a prefabricated device intended for use as the core structure of an artificial prosthesis for placement in the oral cavity in order to restore chewing function. The Procerat Bridge Zirconia is precision milled from one solid piece of densely sintered Zirconia, and can be cemented or bonded to either natural or artificial tooth abutments.

The provided text is a 510(k) Summary for a dental device (Procera® Bridge Zirconia), which describes its intended use and regulatory classification. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in the prompt for proving the device meets acceptance criteria.

The document is a regulatory submission for a physical dental prosthesis, not a software algorithm, and therefore the concepts of "test set," "training set," "experts," "adjudication," "MRMC," or "standalone performance" as they relate to AI/software performance evaluation are not applicable here.

Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving the device meets these criteria based on the provided text.

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Nobel Biocare's Procera® Bridge Zirconia is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera® Bridge Zirconia may be two, three, or four units and are cemented to natural or artificial tooth abulments.

Nobel Biocare's Procera® Bridge Zirconia is a prefabricated device intended for use as the core structure of an artificial prosthesis for placement in the oral cavity in order to restore chewing function.

The Procera® Bridge Zirconia may be two, three, or four units and is precision milled. The Procera® Bridge Zirconia can be cemented or bonded to either natural or artificial tooth aburtments it is personalized according to the specific dimensions of the patient's abutments so the bridge precisely fits, and properly functions, in the patient's jaw.

Nobel Biocare's Procera® Bridge Zirconia is manufactured from one solid piece of densely sintered zirconia.

The provided text does not contain information about acceptance criteria and a study proving a device meets them. The document is a 510(k) summary for a dental device (Procera® Bridge Zirconia), primarily focused on regulatory submission details, device description, and indications for use. It states "No special guidance documents, relative to this device, were found," regarding performance standards, implying that specific quantitative acceptance criteria or a dedicated performance study as typically understood in a medical device context are not detailed in this submission.

Therefore, I cannot provide the requested information in the table or answer the subsequent questions based on the input text.

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