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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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(112 days)
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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