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510(k) Data Aggregation
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LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE
The product is indicated for inlays, onlays, veneers, and full crown restorations, including crowns on implants.
The product is a strong, wear-resistant and highly esthetic mill block that provides a fast and easy-to-use alternative to porcelain blocks for milling CAD/CAM indirect restorations. The material is specially processed to enhance its properties for use in CAD/CAM milling procedures.
The provided text describes a 510(k) submission for a dental restorative material, not a software or AI-powered medical device. Therefore, the information requested about acceptance criteria, study details, ground truth, and AI-specific metrics (like MRMC studies, human reader improvement, standalone performance, and training set information) is not applicable or cannot be extracted from this document.
The document primarily focuses on demonstrating substantial equivalence to predicate dental devices through bench testing of physical properties.
However, I can extract the general "acceptance criteria" in the context of this device being approved based on comparison to predicates and meeting certain material properties.
1. Table of Acceptance Criteria and Reported Device Performance
| Property Evaluated | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Implied by Substantial Equivalence Determination) |
|---|---|---|
| Flexural Strength | Comparable to predicate devices | Deemed substantially equivalent |
| Flexural Modulus | Comparable to predicate devices | Deemed substantially equivalent |
| Compressive Strength | Comparable to predicate devices | Deemed substantially equivalent |
| Diametral Tensile Strength | Comparable to predicate devices | Deemed substantially equivalent |
| Water Sorption | Comparable to predicate devices | Deemed substantially equivalent |
| Water Solubility | Comparable to predicate devices | Deemed substantially equivalent |
| Fracture Toughness | Comparable to predicate devices | Deemed substantially equivalent |
| Biocompatibility | Safe for intended use (based on risk assessment) | Deemed safe for intended use |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for each test. The document states "data from bench testing" was used.
- Data Provenance: Bench testing, likely conducted by 3M ESPE Dental Products. No information about country of origin, retrospective or prospective is relevant as it's a material test.
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):
- Not applicable. This is a material science study, not one requiring expert human interpretation for "ground truth" as you would find in an imaging or diagnostic device. The "ground truth" here is the measured physical properties of the material and its comparison to established predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, not for bench testing of material properties.
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 not an AI-powered device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this type of material device is derived from standardized bench test measurements of physical and chemical properties and comparison to the established performance of legally marketed predicate devices. Biocompatibility was assessed through a "risk assessment techniques and consideration of FDA & internationally recognized guidelines."
8. The sample size for the training set:
- Not applicable. This is not an AI-powered device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI-powered device.
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