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Nobel Biocare's Procera Bridge Alumina 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 Alumina may be two, three, or four units and is cemented to natural or artificial tooth abutments.

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

Nobel Biocare's Procera® Bridge Alumina is manufactured from one solid piece of densely sintered aluminum oxide (Alumina).

The provided text describes a medical device, the Nobel Biocare Procera® Bridge Alumina, and its regulatory clearance (510(k)). However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The document is a 510(k) summary and the corresponding FDA clearance letter. These documents confirm that the device is substantially equivalent to a predicate device and is cleared for marketing. They specify the device's description, indications for use, and regulatory classification but do not include details about performance studies used to demonstrate safety and effectiveness for a new device submission or a comparative effectiveness study.

Therefore, I cannot provide the requested information from the given text.

To be clear:

• 1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
• 2. Sample sized used for the test set and the data provenance: This information is not present in the provided text.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the provided text.
• 4. Adjudication method: This information is not present in the provided text.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not present in the provided text. The device is a physical dental bridge, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present in the provided text. The device is a physical dental bridge, not an algorithm.
• 7. The type of ground truth used: This information is not present in the provided text.
• 8. The sample size for the training set: This information is not present in the provided text.
• 9. How the ground truth for the training set was established: This information is not present in the provided text.

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