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"Ceramill Zold FX" preshade are blanks made of zirconium oxide (ZrO2) for type II, class 5 dental applications in accordance with DIN EN ISO 6872. They are used for manufacturing permanent and removable prosthetic restorations (e.g., crowns and three-unit bridges to the molar region) using CNC milling machines (e.g., Ceramill Motion).
Amann Girrbach AG "Ceramill Zolid FX" is an all-ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a disk shape (U-shape). CAD/CAM fabrication of core material can then be used to produce copings and substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of permanent and removable prosthetic restorations (e.g. crowns and three-unit bridges to the molar region). The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer (the dental technician).
The document provided describes the submission of a medical device (Ceramill Zolid FX) for FDA clearance, demonstrating its substantial equivalence to a predicate device (Ceramill ZI blanks). The information provided focuses on non-clinical performance data and does not contain details about studies involving human readers or AI assistance. Therefore, some of the requested information, particularly related to human reader studies, AI assistance, and large-scale data sets, is not applicable or available in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for "Ceramill Zolid FX" are based on conformance to applicable national and international standards, primarily ANSI ADA Specification No. 69:2010 (Dental Ceramic) and ISO 6872:2008 (Dentistry – Ceramic Materials), as well as internal specifications.
| Test / Performance Metric | Acceptance Criteria (Standard / Predicate) | Reported Device Performance (Ceramill Zolid FX) |
|---|---|---|
| Material Composition (wt%) | Zirconia (ZrO2 + HfO2 + Y2O3 > 99.0%) (Predicate) | Zirconia (ZrO2 + HfO2 + Y2O3 ≥ 99.0%) |
| Y2O3 | 4.5 - 5.6 (Predicate) | 9.15 - 9.55 |
| Al2O3 | < 0.5 (Predicate) | < 0.06 |
| HfO2 | < 5 (Predicate) | < 3 |
| SiO2 and Fe2O3 | < 0.5 (Predicate) | SiO2 < 0.02, Fe2O3 < 0.01 |
| Physical/Mechanical Properties | ||
| Bulk Density | ≥6.07 g/cm³ (Predicate) / Meets ISO 6872 | ≥6.05 g/cm³ / Meets ISO 6872 |
| Open Porosity | 0% (Predicate) / Meets ISO 6872 | 0% / Meets ISO 6872 |
| Grain Size | <0.6 µm (Predicate) | 0.8 µm |
| Flexural Bending Strength | ≥1200 MPa (Predicate) / Meets ISO 13356 & ISO 6872 | >500 MPa / Meets ISO 13356 & ISO 6872 (Note: Lower than predicate, but still meets standard for its limited indications) |
| Weibull Modulus | 10.63 (Predicate) / Meets ISO 13356 & ISO 6872 | 9.54 / Meets ISO 13356 & ISO 6872 |
| Hardness (Vicker's Hardness) | 1300 ± 200 HV10 (Predicate) / Meets internal specifications | 1300 ± 200 HV10 / Meets internal specifications |
| Coefficient of Thermal Expansion | 10.4 ± 0.5 *10-6/K (Predicate) / Meets ISO 9396 & ISO 6872 | 10.1 ± 0.5 *10-6/K / Meets ISO 9396 & ISO 6872 |
| Modulus of Elasticity | >200 GPa (Predicate) / Meets internal specifications | >200 GPa / Meets internal specifications |
| Radioactivity (raw material) | <0.2 Bq/g (Predicate) / Meets ISO 6872 | <0.2 Bq/g / Meets ISO 6872 |
| Biocompatibility | Non-toxicological/biological cell damages and growth inhibition (ISO 10993) | Caused no toxicological/biological cell damages and growth inhibition / Extracts did not contain organic or inorganic detectable substances / Non-cytotoxic |
| Chemical Analysis | No organic or inorganic detectable substances (ISO 10993) | Extracts did not contain organic or inorganic detectable substances |
Note: The differences in flexural strength and Y2O3 content are acknowledged, but the device is still considered substantially equivalent due to its modified indications (e.g., exclusion of longer bridges for Ceramill Zolid FX) and conformance to relevant ISO standards for its intended use classification (Type II, Class 5 aesthetic dental ceramic).
2. Sample size used for the test set and the data provenance
The document refers to "non-clinical testing" without specifying a 'test set' in the context of clinical trials or retrospective/prospective data collection from patients. The testing involved material properties, not patient data. The provenance of the samples (e.g., raw material batches) is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a material science and engineering study for dental ceramic properties, not a study requiring expert clinical read-outs or ground truth establishment by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication process is detailed as it's not a clinical study.
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. The document describes a traditional medical device submission for a dental ceramic material, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No algorithm or AI device is being discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on established international and national standards for dental ceramics (e.g., ISO 6872:2008, ANSI ADA Specification No. 69:2010, ISO 13356, ISO 9396, ISO 10993 standards for biocompatibility) and internal specifications. These standards define the acceptable range or minimum thresholds for various physical, chemical, and biological properties.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI context. The document refers to testing of material batches.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI context. The material's properties are measured directly against established standards.
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