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I am sorry, but the provided text content does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device. The documents are formal letters from the FDA to companies regarding 510(k) premarket notifications, confirming substantial equivalence for two different devices (Cimpat N and Auradapt Abutment System).

These letters discuss:

• The FDA's review of the premarket notification.
• The determination of substantial equivalence to predicate devices.
• Regulatory class and applicable controls (general controls, special controls, or premarket approval).
• Compliance with Good Manufacturing Practice (GMP) and Quality System Regulation (QS).
• Information regarding labeling regulations and other responsibilities under the Act.

They do not include details about:

• Specific performance acceptance criteria for the devices.
• Any studies, their methodology, sample size, data provenance, ground truth establishment, or expert involvement used to demonstrate device performance against such criteria.
• Information about multi-reader multi-case (MRMC) studies or standalone algorithm performance.

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

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