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510(k) Data Aggregation
(145 days)
Shaders™ Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns, and bridges). Shaders™ Zirconia blanks are intended to be milled and fully sintered by a dental laboratory before use. Full contour monolithic crowns and bridges in anterior and posterior regions.
Shaders™ Zirconia are disc shaped dental porcelain zirconia oxide blanks that come in different 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 patient's 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 patient's teeth as dentures, crowns or bridges.
The provided document is a 510(k) summary for a dental device (Shaders™ Zirconia blanks). It does not contain information about studies related to AI or digital healthcare device performance for diagnostics or image analysis. Therefore, I cannot extract the information requested about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical effectiveness studies in the context of AI.
The document discusses the physical and chemical properties of the Shaders™ Zirconia blanks and compares them to a predicate device (Glidewell Prismatik™ Clinical Zirconia) to demonstrate substantial equivalence.
Here's a breakdown of what is provided regarding the device's characteristics and how it meets physical/chemical criteria based on the document:
1. A table of acceptance criteria and the reported device performance
| Criteria (Acceptance Limit) | Reported Device Performance (Shaders™ Zirconia) | Comment (from document) |
|---|---|---|
| Material Composition | Same as predicate | |
| ZrO2+HfO2+Y2O3 | Provided (exact % not in this table) | |
| HfO2 | Provided (exact % not in this table) | |
| Y2O3 | Provided (exact % not in this table) | |
| Al2O3 | Provided (exact % not in this table) | |
| Other oxides | Provided (exact % not in this table) | |
| Freedom from extraneous materials per ISO 6872:2008 Section 5.2 active conc. of not more than 1.0 Bq g⁻¹ of Uranium238 | 900MPa | 1103 MPa |
| Chemical solubility per ISO 6872:2008, Limit 100 µg/cm² | 18.1 µg/cm² | Test passed |
| Biocompatibility per ISO 10993-1: Part 1 | Assured through use of same materials and manufacturing methods as legally marketed predicate devices | Similar compositions and manufacturing methods. |
| Blank sizes(mm) | Disc: 98.5-100mm x 10-30mm thick | Same as predicate |
Additional Chemical Properties (from a separate table in the document):
| Component (chemical composition) | Shaders™ Zirconia (percentage by wt.) |
|---|---|
| ZrO2 + HfO2 + Y2O3 + Al2O3 | > 99.9 |
| Y2O3 | 5.35 - 5.95 |
| Al2O3 | ≤0.1 |
| SiO2 | ≤0.02 |
| Fe2O3 | ≤0.01 |
| Chemical solubility | 18.1 µg/cm² |
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 document refers to "sintered tests coupled with mechanical bench testing" to confirm specifications but does not detail the sample sizes or data provenance for these non-clinical tests.
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)
This is not applicable as the document describes a material and its physical/chemical properties, not a diagnostic or AI device requiring expert ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for the type of device and testing described.
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-assisted device for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance relies on established international standards for dental ceramic materials (ISO 6872:2008 and ISO 13356: 2008) and direct measurement of physical and chemical properties (e.g., density, flexural strength, chemical solubility, fracture toughness).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model.
9. How the ground truth for the training set was established
Not applicable.
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