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510(k) Data Aggregation
(167 days)
This device is a ceramic-based material that is used for prefabricated and patient-matched dental restorations such as inlays, artificial teeth, crowns, or bridges (up to maximum three-unit bridges) and processed by dental CAD/CAM.
The Eclipse Kiss Zirconia Dental Material is an integrated system of dental ceramic which support dental restorations and which are milled into prosthetic devices such as Crowns, Bridges, and Copings for partial and fully edentulous patients. The material can be milled into a variety of dental restorations to meet the specific needs of individual dental patients. Each patient is named by a physician or dentists written prescription specifying the type of restoration to be produced.
Eclipse Kiss Zirconia is intended to be used as a biocompatible material to be milled into precise customized dental restoration units for either crowns, copings or bridges (up to maximum three unit bridges); which may be further processed by the addition of ceramic layering to create aesthetic lifelike restorations.
Eclipse Kiss Zirconia is intended to be used as prescribed by a qualified and licensed physician or dentist by a written prescription which names the patient for which each individual dental restoration to be produced.
This document is a 510(k) Premarket Notification for a dental material, Eclipse Kiss Zirconia. It primarily focuses on demonstrating substantial equivalence to a predicate device (DD Cubex2) rather than presenting a study proving the device meets general acceptance criteria.
Therefore, much of the requested information regarding specific acceptance criteria studies with human readers, training sets, test sets, and adjudication methods is not available in the provided text. This document is a regulatory submission for a material, not usually for a diagnostic AI device.
However, I can extract the available information regarding performance properties and the comparison study for demonstrating substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
For dental materials like Eclipse Kiss Zirconia, "acceptance criteria" are typically defined by performance properties that demonstrate the material's fitness for its intended use and similarity to established predicate devices. The document explicitly lists performance properties and compares them to the predicate device, DD Cubex2.
| Performance Property | Acceptance Criteria (Predicate Device: DD Cubex2) | Reported Device Performance (Eclipse Kiss Zirconia) | Meets Criteria? |
|---|---|---|---|
| Flexural strength [MPa] | > 720 | ~ 749 | Yes |
| Density [g/cm³] | > 6.0 | > 6.0 | Yes |
| Coefficient of thermal expansion [10⁻⁶K⁻¹] | 10 | 10.3 | Yes |
| Chemical composition | ZrO2+HfO2+Y2O3 ≥ 99 wt%Y2O3 < 10 wt%HfO2 < 0.2 wt%Al₂O₃ < 0.1 wt% | ZrO2+HfO2+Y2O3 ≥ 99 wt%Y2O3 < 10 wt%Fe2O3 ≤ 0.0002 wt%NiO ≤ 0.00008 wt% | Yes (similar, with specific impurity limits) |
| Sintering temperature | 1450 °C | 1450 °C | Yes |
| Biocompatibility | Suitable (implied by predicate's acceptance) | Suitable | Yes |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of an algorithm or diagnostic device. Instead, it refers to non-clinical performance studies for the material properties. The specific sample sizes for tests such as flexural strength, density, and thermal expansion are not provided in this summary.
The data provenance for these physical and chemical tests is not explicitly stated in terms of country of origin or retrospective/prospective nature, but these are standard laboratory tests conducted on samples of the manufactured material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The "test set" here refers to material property measurements, not clinical evaluations requiring expert consensus or ground truth in the diagnostic sense.
4. Adjudication method for the test set
This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are relevant for clinical assessments involving multiple readers/experts, which is not the nature of this submission.
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
This information is not applicable and not provided. This document pertains to a dental material, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This document pertains to a dental material, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance properties of the dental material would be the measured values obtained through standardized laboratory testing methods (e.g., ISO standards for flexural strength, density, etc.). For biocompatibility, the ground truth is established by adherence to standards like ISO 10993.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" in the context of a dental material submission being evaluated for its physical and chemical properties.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reasons as #8.
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