(267 days)
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
| Acceptance Criterion (Standard) | Device Performance (Copra Smile) | Device Performance (Copra Supreme Hyperion) | Predicate Device (3M Lava Esthetic) | Reference Device (Ivoclar ZirCad MT) |
|---|---|---|---|---|
| ISO 6872:2015 for Physical Properties | All parameters meet the standard | All parameters meet the standard | Meets ISO 6872:2015 | Meets ISO 6872:2015 |
| Type of Material (ISO 6872:2015) | Type II Class 4 | Type II Class 5 | Type II Class 4 | Type II Class 5 |
| Flexural Strength (MPa) | 600-800 | 600-1100 | 800 | 800 |
| Fracture Toughness (MPa·m1/2) | 3.5 | 3.5 | 3-5 | 3-5 |
| ISO 10993-1:2018 for Biocompatibility | Assessment done in accordance with standard | Assessment done in accordance with standard | Not explicitly stated but assumed for a legally marketed device | Not explicitly stated but assumed for a legally marketed device |
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.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.