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510(k) Data Aggregation
(277 days)
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.
| Acceptance Criteria (from ISO 6872:2015 and Predicate/Reference) | Copran Zri Performance | Notes |
|---|---|---|
| Physical Properties | ||
| ISO 6872:2015 Classification | Type II Class 5 | Copran Zri, Copran Zri Light, Medium and Intense all meet this classification, which is consistent with the reference and predicate devices. This standard dictates properties for ceramic materials for dental restorations. |
| Bending/Flexural Strength (MPa) | 1400 | Reported as 1400 MPa for Copran Zri. The predicate device (Ivoclar ZirCad MO) has 1150 MPa, and the reference device (Copran Zr) has 1400 MPa. Copran Zri meets or exceeds the predicate. |
| Fracture Toughness (MPa·m1/2) | 5 | Reported as 5 MPa·m1/2 for Copran Zri. The predicate device has >5.1 MPa·m1/2, and the reference device has 5 MPa·m1/2. Copran Zri is comparable to the reference and close to the predicate. |
| Solubility (µg/cm²) | 6.7 | Reported as 6.7 µg/cm² for Copran Zri. The predicate device has <100 µg/cm², and the reference device has 6.7 µg/cm². Copran Zri significantly exceeds the predicate in terms of lower solubility (which is better). |
| CTE (25-500°C) 10-6/K | 10.2 | Reported as 10.2 10-6/K for Copran Zri. The predicate device has 10.5 ± 0.5 10-6/K, and the reference device has 10.2 10-6/K. Copran Zri is within the range of the predicate and matches the reference. |
| Radioactivity (Bq·g-1) | < 0.0117 Bq·g-1 (238U) | Reported as < 0.0117 Bq·g-1 (238U) for Copran Zri. The predicate device does not have this present in labeling (implying it meets standards or is not relevant). The reference device matches Copran Zri. This indicates compliance with relevant safety standards. |
| Biocompatibility | ||
| ISO 10993-1:2018 Compliance | Compliant | A biocompatibility assessment was done in accordance with ISO 10993-1:2018. The document implies successful completion. |
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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