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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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