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510(k) Data Aggregation
(196 days)
Crystal® Ultra is indicated for use as a dental restoration including inlays, onlays, veneers, crowns, and bridges.
For use by or on the order of a dental professional.
The Crystal® Ultra CAD/CAM formed materials consist of interpenetrating networks of glass ceramic and polymer material to form a solid block of material. The unique marriage of the two materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This results in a material with significantly lower brittleness compared to a pure ceramic and better abrasion behavior than a pure resin, (similar to natural enamel). The material is milled in a dental CAD/CAM machine into its restorative form.
The provided text describes a 510(k) submission for a dental CAD/CAM material called "Crystal® Ultra." This device is a material, not an AI-powered diagnostic tool, and therefore most of the requested information about acceptance criteria, study design, and ground truth establishment for AI performance metrics are not applicable.
However, I can extract the relevant information regarding the non-clinical performance data and how the device's equivalence was established.
1. A table of acceptance criteria and the reported device performance
The submission states that bench testing was performed in accordance with FDA recognized standards and compared to predicate devices. The "acceptance criteria" here are implicitly the satisfactory performance against these standards and demonstrating substantial equivalence to the predicate devices. The reported device performance is that it met these criteria.
| Performance Metric (Standard) | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Flexural Strength (ISO 6872) | Comparable to predicate devices | Substantially equivalent to predicate devices |
| Chemical Solubility (ISO 10477) | Comparable to predicate devices | Substantially equivalent to predicate devices |
| Elasticity (ISO 10477) | Comparable to predicate devices | Substantially equivalent to predicate devices |
| Compressive Strength (ISO 10477) | Comparable to predicate devices | Substantially equivalent to predicate devices |
| Density (ISO 10477) | Comparable to predicate devices | Substantially equivalent to predicate devices |
| Water Absorption (ISO 4049) | Comparable to predicate devices | Substantially equivalent to predicate devices |
| Shade Stability (ISO 4049) | Comparable to predicate devices | Substantially equivalent to predicate devices |
| Color Consistency (ISO 4049) | Comparable to predicate devices | Substantially equivalent to predicate devices |
| Water Solubility (ISO 4049) | Comparable to predicate devices | Substantially equivalent to predicate devices |
| Radioactivity | Assessed for safety | Included in testing, results are satisfactory for substantial equivalence |
| Storage Stability | Assessed for performance over time | Included in testing, results are satisfactory for substantial equivalence |
| Bond Strength | Assessed for clinical application | Included in testing, results are satisfactory for substantial equivalence |
| Modulus of Elasticity | Assessed for mechanical properties | Included in testing, results are satisfactory for substantial equivalence |
| Biocompatibility (ISO 10993) | Meets biocompatibility standards for dental materials | Concluded to be substantially equivalent in safety to predicate device |
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 does not specify the sample sizes for the bench tests. The tests were performed in accordance with FDA recognized standards (ISO 6872, ISO 10477, ISO 7405, ISO 4049, ISO 10993). These are likely laboratory bench tests, not clinical studies involving human patients or specific geographical data provenance. Therefore, terms like "retrospective or prospective" are not applicable.
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 is not applicable as the device is a material, and the "ground truth" for its performance is established through standardized physical and chemical testing, not expert interpretation of cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for a material test. The "adjudication" is based on the results of standardized laboratory tests against predefined specifications.
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. This device is a material, not an AI or diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is derived from standardized physical and chemical measurements obtained through bench testing according to ISO standards (e.g., flexural strength, solubility, density). The comparison is made to the established performance characteristics of legally marketed predicate dental materials.
8. The sample size for the training set
This is not applicable as the device is a dental material, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device.
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