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Copra Supreme zirconia blanks are indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

Pre-sintered zirconia blanks for the fabrication of individual dental restorations. Copra Supreme disks come in both white and pre-shaded 0M1-D4 in various sizes.

The provided document is a 510(k) summary for a dental device (zirconia blanks) and does not describe an AI/ML-enabled device or a study involving human readers or ground truth established by experts. Therefore, I am unable to provide the detailed information requested regarding acceptance criteria and performance evaluation of an AI device.

The document primarily focuses on establishing substantial equivalence for a physical dental material (zirconia blanks) to legally marketed predicate devices. The "Testing Summary" section on page 5 states: "The physical properties of Copra Supreme were tested according to ISO 6872:2015 and all parameters meet the standard. Flexural strength, coefficient of thermal expansion, solubility and radioactivity were tested." This refers to material property testing, not performance criteria for a diagnostic AI algorithm.

The table presented on pages 6-7 compares the characteristics of the subject device (Copra Supreme zirconia blanks) to predicate and reference devices, including:

• Acceptance Criteria/Performance Metrics (as reported for a physical material):
  • Flexural Strength (MPa)
  • Fracture Toughness (MPa·m1/2)
  • Solubility (µg/cm²)
  • Radioactivity (Bq·g-1 238U)

Since the request is about an AI/ML device and the provided document is for a physical dental material, most of the requested fields are not applicable.

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