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Used by a dental lab technician, under the direction of an attending dentist, to fashion and bake porcelain veneers onto dental alloy substrates so as to create the porcelainfused-to-metal elements of a fixed or removable dental prosthesis. Carrara Porcelain and Carrara Vincent Porcelain are recommended for use only with Carrara and Cera E dental alloys. After fabrication and finishing, the completed prosthesis is approved and placed in the patient's mouth by the dentist.

Carrara Porcelain and Carrara Vincent Porcelain

This is a 510(k) clearance letter for "Carrara Porcelain and Carrara Vincent Porcelain," dated May 15, 1998. The document does not contain any information regarding acceptance criteria or a study proving device performance.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which means it met the regulatory standard at the time for marketing. It does not provide performance data from a clinical or non-clinical study to demonstrate specific acceptance criteria.

Therefore, for all the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for the training set), the answer is: Not applicable or not provided in the given document.

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