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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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Copran Zri consists of machinable zirconia discs for the preparation of full ceramic crowns, onlays and 3-and 4-unit bridges and inlay bridges (anterior and molar.)

Pre-sintered zirconia blanks for the fabrication of individual dental restorations.

Copran Zri disks come in both white and pre-shaded light, medium or intense in 95 and 98 mm diameter in thicknesses from 10-25mm.

This is a 510(k) premarket notification for a medical device called "Copran Zri," which consists of machinable zirconia discs for dental restorations. The document asserts that this device is substantially equivalent to a predicate device, Ivoclar IPS e.max ZirCad MO (K051705), and references Whitepeaks Copran Zr (K092496).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document implicitly uses the performance of the predicate and reference devices, as well as standards like ISO 6872:2015, to establish acceptance criteria. The table below compiles the reported device performance for Copran Zri in comparison to these.

The statement: "The physical properties of Copran Zri were tested according to ISO 6872:2015 and all parameters meet the standard" and "Both the subject devices, the predicate devices and the reference devices physical properties meet ISO 6872:2015" confirms that meeting this standard served as the primary acceptance criteria for physical properties.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document states: "The physical properties of Copran Zri were tested according to ISO 6872:2015". However, it does not specify the sample size used for these tests.
The data provenance is also not stated. We know the manufacturer is Whitepeaks Dental Solutions GmbH from Germany, so the testing was likely conducted in Germany or a location associated with their operations or chosen testing facilities. It's also not specified if the testing was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable to this type of device submission. The device is a material for dental restorations. Its performance is evaluated through standardized physical, chemical, and biological tests, not through expert reading of images or diagnoses. Therefore, there's no "ground truth" derived from expert consensus in the clinical sense mentioned in the prompt.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable for the same reasons as point 3. The evaluation is based on objective measurements against established international standards (ISO 6872:2015, ISO 10993-1:2018), not on subjective expert interpretation requiring adjudication.

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 is not applicable. The device is a material for dental restorations, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable as the device is not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for evaluating this device's performance is established by international standards for dental materials (specifically ISO 6872:2015 for ceramic materials) and biocompatibility standards (ISO 10993-1:2018). These standards define the acceptable range or minimum/maximum values for critical physical and biological properties. The results of laboratory tests are compared directly against these numerical benchmarks.

8. The sample size for the training set:

This is not applicable. The device is not an AI model, and therefore, there is no "training set."

9. How the ground truth for the training set was established:

This is not applicable for the same reason as point 8.

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Copra Smile consists of machinable zirconia discs and blocks for preparation of single crowns, bridges with maximum of one pontic between two crowns and inlays, onlays and veneers.

Copra Supreme Hyperion consists of machinable zirconia discs and blocks for the preparation of full ceramic crowns, onlays and 3- and 4-unit bridges and inlay bridges (anterior and molar).

Pre-sintered zirconia blanks for the fabrication of individual dental restorations.

Copra Smile disks and blocks come in both white and pre-shaded in 0M1, 0M2, 0M3, A1-D4 and Joy Five-Nine in various sizes. Copra Supreme Hyperion disks and blocks come pre-shaded in 0M1, 0M2, 0M3, A1-D4 and Joy Five-Nine in various sizes.

The provided text describes a 510(k) premarket notification for dental zirconia blanks and does not contain information about a study proving the device meets acceptance criteria as typically found for AI/ML-enabled medical devices. The device in question, Copra Smile and Copra Supreme Hyperion, are "Porcelain Powder For Clinical Use" (Class II, Product Code: EIH), which are physical materials, not software or AI/ML components.

The "Testing Summary" in the document states:
"The physical properties of Copra Smile and Copra Supreme Hyperion were tested according to ISO 6872:2015 and all parameters meet the standard. A biocompatibility assessment of Copra Smile and Copra Supreme Hyperion was done in accordance with ISO 10993-1:2018."

This indicates that the acceptance criteria are adherence to the ISO 6872:2015 standard for physical properties of dental ceramics and ISO 10993-1:2018 for biocompatibility.

Here's the information, structured as requested, based on the provided text, with clarifications where details are not present for an AI/ML context:

1. A table of acceptance criteria and the reported device performance

Note: The detailed acceptance values within ISO 6872:2015 for "all parameters" are not explicitly listed in the document beyond Flexural Strength and Fracture Toughness. The document states that the physical properties of the subject devices, predicate, and reference devices all meet ISO 6872:2015.

2. Sample sized used for the test set and the data provenance

• Sample Size: The document does not specify the sample size for the physical properties and biocompatibility testing. This would typically be detailed in the test reports, which are summarized here.
• Data Provenance: Not explicitly stated, but the testing would typically be performed by the manufacturer or a contracted lab to generate data for submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as this is not an AI/ML device requiring expert ground truth in the traditional sense. The "ground truth" here is established by the physical and chemical properties of the material and its biological interaction determined through standardized tests, rather than expert interpretation of images or other data.

4. Adjudication method for the test set

Not applicable as this is not an AI/ML device requiring adjudication of expert interpretations. The tests for physical properties and biocompatibility are objective, standardized measurements.

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

Not applicable. This is a physical dental material, not an AI-assisted diagnostic tool or software.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical dental material, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device (Copra Smile and Copra Supreme Hyperion) is established by:

• Standardized Physical Property Measurements: Adherence to the specifications outlined in ISO 6872:2015 for dental ceramic materials (e.g., specific values for flexural strength, fracture toughness, chemical composition, microstructure).
• Biocompatibility Testing: Results from tests conducted according to ISO 10993-1:2018 to evaluate the biological response to the material.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set. The "training" in manufacturing would relate to process control and material formulation development, not data-driven model training.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/ML model. The formulation and manufacturing parameters for the dental blanks would be established through material science research, development, and quality control processes to ensure the desired physical and chemical properties are achieved consistently.

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