(123 days)
GenesisZr™ 4Y Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges). GenesisZr™ 4Y Zirconia blanks are intended to be milled and fully sintered before use for:
- Full contour monolithic crowns and bridges in anterior and posterior regions.
- Anatomically reduced for veneering, crown and bridge frames.
- Bridge to be limited to 3 units with a maximum of 1 pontic.
GenesisZr™ 4Y Zirconia are disc shaped dental porcelain zirconia oxide blanks that come in one color, white, and various sizes that are used in customized restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the customized rendered blank is milled the device is fully sintered and colored (if required) and fitted to the patient's teeth as dentures, crowns or bridges.
The provided document is a 510(k) Premarket Notification for a dental device, GenesisZr™ 4Y Zirconia. This document primarily focuses on establishing substantial equivalence to a predicate device based on material properties, indications for use, and standardized bench testing.
It explicitly states that "Clinical tests have not been performed." Therefore, the document does not contain information related to acceptance criteria for clinical performance, human reader studies (MRMC), or ground truth establishment based on expert consensus, pathology, or outcomes data as would be typically found for AI/imaging devices.
The "acceptance criteria" and "device performance" in this context refer to the results of non-clinical, bench testing against established ISO standards for dental materials.
Here's the information that can be extracted from the provided text, framed within your request:
1. A table of acceptance criteria and the reported device performance
| Test Parameter / Acceptance Criteria (Standard) | Reported Device Performance (GenesisZr™ 4Y Zirconia) | Predicate Device Performance (Prismatik™ CZ), if available |
|---|---|---|
| Material Composition % wt. | ||
| Zirconia Powder: ZrO2+HfO2+Y2O3: >99 | >99 | >99 |
| Y2O3: (Predicate: 5.2) | 6.9 | 5.2 |
| Al2O3: ≤ 0.05 | ≤ 0.05 | ≤ 0.05 |
| SiO2: ≤0.002 | ≤0.002 | N/A (Other oxides: 900MPa) |
| Chemical solubility per ISO 6872:2008 (Limit 100 µg/cm²) | 6.0 µg/cm² | N/A |
| Biocompatibility per ISO 10993-1: Part 1 | Biocompatibility risk management analysis conducted. | N/A |
| Blank sizes (mm) | Disc: 95-110mm x 10-30mm | Disc sizes: 98.5 x 10-30mm |
2. Sample sizes used for the test set and the data provenance
The document does not specify the sample sizes (e.g., number of test pieces, batches) used for each non-clinical test. The tests were performed on the GenesisZr™ 4Y Zirconia material itself. The data provenance is from internal testing performed by United Dental Resources Corporation. The document does not specify country of origin for the data or whether it's retrospective or prospective, as these terms are not applicable to the non-clinical material testing described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device is based on compliance of material properties with established international standards (ISO standards) and not on expert clinical interpretation of data.
4. Adjudication method for the test set
Not applicable. There was no human interpretation or adjudication involved, as it was non-clinical material testing against pre-defined physical and chemical property limits.
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 device is a dental material, not an AI-assisted diagnostic or imaging device. Clinical tests as such were explicitly not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm. Performance was evaluated based on the physical and chemical properties of the material itself.
7. The type of ground truth used
The "ground truth" for this submission is compliance with the requirements specified in international standards such as ISO 6872:2008 ("Dentistry - Ceramic materials") and ISO 13356: 2008 ("Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)"). It also includes a biocompatibility risk management analysis per ISO 10993-1.
8. The sample size for the training set
Not applicable. This is a material, not a machine learning model. There is no concept of a "training set" for the type of testing described.
9. How the ground truth for the training set was established
Not applicable for the reason stated above.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.