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510(k) Data Aggregation
(166 days)
Pavati® Z40.2 Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (crowns and bridges) in the anterior/ posterior applications.
Pavati® Z40.2 Zirconia blanks are intended to be milled and fully sintered by Dental Professional or Dental Laboratory before use. Pavati® Z40.2 Zirconia blanks are for "Rx only" and not for use by the general public or sold as "Over- the-Counter".
Pavati® Z40.2 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 is a 510(k) Summary for a dental device, specifically Pavati® Z40.2 Zirconia blanks. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new, AI-powered diagnostic device or a device requiring clinical studies.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from this document, as it describes a material for prosthetic dentistry, not an AI/diagnostic device.
However, I can extract information related to the physical and chemical properties and their compliance with established standards, which serve as the acceptance criteria for this type of material.
Acceptance Criteria and Device Performance for Pavati® Z40.2 Zirconia
The device is a dental material, and its performance is evaluated against physical and chemical properties as defined by international standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Pavati® Z40.2 Zirconia) |
|---|---|
| Physical Properties (Sintered Product) | |
| Sintered Density (ISO 13356:2015, Req't. $\geq$ 6.00 g/cm³) | $\geq 6.00 \text{ g cm}^3$ (Meets ISO Standard) |
| Thermal Expansion Coefficient (20-500°C) (ISO 6872:2015, No req't. report number) | 10.3 µm/m °C (Meets ISO Standard) |
| Bending Strength (ISO 6872:2015, Limit >300 MPa) | > 600 MPa (Meets ISO Standard) |
| Grain Size (ISO 13356:2015, No req't. for grain size) | 0.81 µm (Meets ISO Standard) |
| Fracture Toughness KIC (ISO 6872:2015 Annex A, minimum for class 3, 2.0 MPa m$^{1/2}$) | >2.0 $\text{MPam}^{0.5}$ (Meets ISO Standard) |
| Chemical Solubility (ISO 6872:2015, 99.9 | |
| Y2O3 | 9.85% ± 0.65 |
| Al2O3 | $\leq$ 0.1 |
| SiO2 | $\leq$ 0.02 |
| Fe2O3 | $\leq$ 0.01 |
| Freedom from extraneous materials (ISO 6872:2015 Section 5.2, active conc. of not more than 1.0 Bq g-1 of Uranium238) | Meets ISO Standard |
| Biocompatibility | |
| ISO 10993-1: Biological evaluation of medical devices | Biocompatible and Non-toxic |
Since this document describes a dental material and not an AI or diagnostic device, the following points are not applicable and no information can be extracted or inferred from the provided text for them:
- Sample size used for the test set and the data provenance: Not applicable. Material testing often involves a fixed number of samples per test type according to standard protocols, but specific "test set" or "data provenance" in the context of diagnostic performance is not relevant here.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established through standardized laboratory measurements.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this material, the "ground truth" is defined by the physical, chemical, and biological properties measured and specified in international standards (ISO 6872:2015, ISO 13356:2015, ISO 10993-1).
- The sample size for the training set: Not applicable. This is not an AI model.
- How the ground truth for the training set was established: Not applicable. This is not an AI model.
The study that proves the device meets the acceptance criteria is detailed in Section 7, "Nonclinical Testing," and Section 6, "Physical and Performance Characteristics." CCRI performed a series of tests, including "Sintered tests coupled with mechanical bench testing," to confirm that the device meets specifications, including established international standards and guidance documents. These tests covered density, bending strength, fracture toughness, chemical solubility, and material characterization/composition on the finished product. The device's compliance with ISO 6872:2015 and ISO 13356:2015 is explicitly stated. Biocompatibility was also confirmed per ISO 10993-1.
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