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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.
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(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 |
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(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.
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