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510(k) Data Aggregation
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Pavati™ Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (crowns and bridges) in the anterior/ posterior applications. Pavati™ Zirconia blanks are intended to be milled and fully sintered by Dental Professional or Dental Laboratory before use. Pavati™ Zirconia blanks are for "Rx only" and not for use by the general public or sold as "Over-the-Counter".
Pavati™ Zirconia are disc and block shaped dental porcelain zirconia oxide blanks that come in various sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patients teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patients teeth as crowns or bridges.
The provided text describes the regulatory clearance for the Pavati™ Zirconia dental material. It is not a study describing acceptance criteria and performance of an AI-powered medical device. The document pertains to a traditional medical device (dental material), not an algorithm or AI system. Therefore, I cannot extract the requested information regarding AI device acceptance criteria, study details, sample sizes, expert involvement, or adjudication methods, as these concepts are not relevant to this type of medical device submission.
The document discusses the physical and chemical properties of the Pavati™ Zirconia blanks and compares them to predicate devices based on established international standards for dental materials.
Here's what information can be extracted relevant to the provided document's content, rephrased to align with the prompt's structure where possible, but acknowledging it's not an AI device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ISO standards) | Reported Device Performance (Pavati™ Zirconia) |
|---|---|
| Sintered Density (ISO 13356: 2008 Section 4.1 Req't. of ≥ 6.0 g/cm³) | ≥ 6.09 g cm³ (Meets ISO Standard) |
| Thermal Expansion Coefficient (20-500°C) | 10.1 µm/m °C (Meets ISO Standard - no specific req't in ISO 6872:2008, report number only) |
| Bending Strength (ISO 6872:2008, Limit >900MPa) | > 900 MPa (Meets ISO Standard) |
| Grain size (ISO 13356:2008, no req't.) | 0.45 µm (Meets ISO Standard - no specific req't in ISO 13356:2008, determined) |
| Fracture toughness (ISO 6872:2008 Annex A; minimum for class 6, 5.0 MPa m 1/2) | 5 MPam0.5 (Meets ISO Standard) |
| Chemical solubility (ISO 6872:2008 Limit 100 µg/cm²) | 18.1 µg/cm² (Meets ISO Standard) |
| Material Composition (ZrO2+HfO2+Y2O3) (ISO 13356:2008 for Material composition, ≥ 99.0 wt%) | > 99.9% (Pavati™ Zirconia percentage by wt.) |
| Y2O3 (ISO 13356:2008, > 4.5 to ≤ 6.0 wt%) | 5.35 - 5.95 wt% |
| Al2O3 (ISO 13356:2008, ≤ 0.5 wt%) | ≤0.1 wt% |
| SiO2 | ≤0.02 wt% |
| Fe2O3 | ≤0.01 wt% |
| Freedom from extraneous materials (ISO 6872:2008 Section 5.2 active conc. of not more than 1.0 Bq g-1 of Uranium238) | Meets ISO Standard |
| Amount of monoclinic phase (ISO 13356:2008, ≤20%) | Meets ISO Standard |
| Biocompatibility (ISO 10993-1: 2009) | Assured through use of same materials and manufacturing (claims biocompatibility per ISO 10993-1:2009) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is bench testing of material properties, not a clinical trial or performance evaluation on a "test set" in the context of an AI device.
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 not an AI device requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" equivalent in this context is established by international standards (ISO 6872:2008 and ISO 13356:2008) for dentistry ceramic materials. These standards define the acceptable physical and chemical properties.
8. The sample size for the training set
Not applicable. This is not an AI device with a training set.
9. How the ground truth for the training set was established
Not applicable.
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