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Creation CP-ZI Porcelain is a pressable ceramic material intended to be used by dental technicians to construct veneers, inlays and ceramic crowns. CP-ZI can be pressed to zirconium oxide ceramic substructures for construction of ceramic crowns and bridges.

Creation CP-ZI porcelain consists of pressable ceramic pellets that are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and bridges. Creation CP-ZI is also suitable a s a stand-alone press ceramic for fabricating inlays and onlays.

The provided text describes a dental product (Creation CP-ZI Porcelain) and its 510(k) summary for FDA clearance. However, it does not contain any information about acceptance criteria, device performance metrics, or a study design involving statistical analysis, sample sizes for test/training sets, expert involvement, or comparative effectiveness studies (MRMC or standalone AI performance).

The document focuses on:

• Device Description: A pressable ceramic material for dental restorations (crowns, bridges, inlays, onlays).
• Predicate Devices: Willi Geller Creation CP and Creation ZI.
• Substantial Equivalence: The submission argues that Creation CP-ZI is substantially equivalent to the predicate devices based on shared chemical qualities and mechanical properties.
• FDA Clearance: The letter confirms 510(k) clearance based on substantial equivalence.
• Indications for Use: Specifies how the material is intended to be used by dental technicians.

Therefore, I cannot fulfill the request to provide the acceptance criteria, reported device performance, or details of a study with the specific elements requested (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication, MRMC/standalone studies, etc.) because such information is not present in the provided text.

The text states: "Data has been presented to demonstrate that the respective mechanical properties, chemical qualities, and the indications for use make Creation CP-ZI substantially equivalent to the predicate devices Willi Geller Creation CP and Willi Geller Creation ZI porcelains The safety and effectiveness of Creation CP-ZI, being determined by the shared chemical qualities and mechanical properties, is therefore equivalent to the predicate devices." This indicates that some form of data comparing the new device's chemical and mechanical properties to the predicate devices was provided, but the specific details of that data, the performance metrics used, and any acceptance criteria for those metrics are not included in this summary.

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