Search Results
Found 3 results
510(k) Data Aggregation
(358 days)
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.
Ask a specific question about this device
(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.
Ask a specific question about this device
(358 days)
HCG Zirconia Ceramic Block are intended for the fabrication of copings and full anatomical/full contour crowns, bridges, inlays, and onlays for anterior and posterior segment restorations.
"HCG Zirconia Ceramic Block" is a ceramic block composed of zirconia compounds. It is suitable for manufacture of dental crowns and bridges cut in the conventional manner or with the help of CAD/CAM.
The provided text describes the 510(k) summary for the HCG Zirconia Ceramic Block, which is a dental device. The information details non-clinical testing performed to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria for an AI/ML-driven medical device.
Therefore, the document does not contain the requested information regarding:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sample size, or how ground truth for training data was established.
This document focuses on the physical and chemical properties, biocompatibility, and functional testing of a zirconia ceramic block against established standards (e.g., ASTM, ISO) to demonstrate its equivalence for dental restorations. It explicitly states: "No clinical test data was used to support the decision of substantial equivalence."
In summary, this document is not a study proving an AI/ML device meets acceptance criteria. It is a submission for a dental material (zirconia block) based on non-clinical performance and substantial equivalence to existing predicate devices.
Ask a specific question about this device
Page 1 of 1