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510(k) Data Aggregation
(595 days)
METOXIT Z-CAD® smile blanks are indicated for the preparation of full ceramic crowns, inlays, veneers and 3 unit bridges in the anterior area. All white Z-CAD® smile blanks are indicated to be coloured with Z-CAD® Liquid smile-TC.
The Z-CAD® Liquid smile-TC will be used to dye white pre-sintered zirconia restorations milled from Z-CAD® smile blanks in the dental field.
Z-CAD® smile ceramic blanks are indicated for the production of dental-prosthetic restorations. The blanks named above can be machined with CAM, CAD/CAM or copy milling systems commonly used in dental medical technology to produce dental-prosthetic restorations made from zirconium oxide. This material offers excellent properties with regards to bio-compatibility, stability and aesthetics, which make it the material of choice for the production of restorations for dental crowns, inlays, onlays, veneers, and up to three unit bridges, which in turn combine the advantages of conventional casting technology and full ceramics. Dental technicians are therefore in a position to offer patients the extra added value when finishing the prosthesis.
Metoxit Z-CAD® smile Blanks also includes Z-CAD® Liquids smile-TC. Z-CAD® Liquids smile-TC are ready for use water-based products, which are applied to the milled restauration prior to sintering to achieve individual shades. These liquids are specifically formulated for the dyeing of Z-CAD® smile blanks from Metoxit AG.
The provided text describes the 510(k) summary for the Z-CAD® Smile device, which is a dental ceramic blank used for prosthetic restorations. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study report with detailed acceptance criteria and performance data in a traditional clinical trial format.
However, I can extract the relevant information regarding performance testing and acceptance criteria for the physical properties of the device as presented, and address the other points based on the available text.
Acceptance Criteria and Device Performance Study for Z-CAD® Smile
The Z-CAD® Smile device is a dental ceramic blank. The performance data presented focuses on physical and biocompatibility properties, demonstrating its safety and effectiveness by comparison to a predicate device and established standards.
1. Table of Acceptance Criteria and Reported Device Performance (Physical Properties):
| Physical Property | Units | Z-CAD® Smile Acceptance Criteria | Reported Z-CAD® Smile Performance | Primary Predicate Device Performance | Testing Method |
|---|---|---|---|---|---|
| Bending strength (biaxial) | MPa | $\ge 500$ | 610 | > 500 | ASTM C1161 |
| Solubility (acetic acid) | µg/cm$^2$ | $\le 100$ | $\le 50$ | < 100 | ISO 6872 |
| Radioactivity (raw material) | Bq/kg | $\le 200$ | < 45 | < 200 | GS |
| Coefficient of Thermal Expansion* | $10^{-6}$/K | N/A (Similar) | 10 | $10.1 \pm 0.5$ | N/A |
*Note: The Coefficient of Thermal Expansion is listed as "Similar, does not influence safety or effectiveness" rather than a specific acceptance criterion with a pass/fail value.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each physical property test. The study appears to be a retrospective comparison based on the characteristics of the manufactured device and existing predicate devices, rather than a prospective clinical study involving patient data. The provenance of the data is from the manufacturer, Metoxit AG, Switzerland.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable in this context. The "ground truth" for the physical properties are established by standardized testing methods (ASTM C1161, ISO 6872, GS) which yield objective measurements. Expert consensus would not be used for these types of material property evaluations.
4. Adjudication Method for the Test Set:
Not applicable. Physical property tests are objective measurements and do not typically involve adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The Z-CAD® Smile is a material used for dental restorations, and its effectiveness is assessed through physical properties and biocompatibility, not reader interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. There is no algorithm or AI component to the Z-CAD® Smile device described in this submission. The performance assessment is standalone in the sense that it relies on laboratory testing of the material itself.
7. The Type of Ground Truth Used:
The "ground truth" for the performance claims are based on:
- Standardized Physical Property Measurements: Using methods like ASTM C1161, ISO 6872, and GS to quantify material properties (Bending Strength, Solubility, Radioactivity, Coefficient of Thermal Expansion).
- Biocompatibility Testing Standards: Adherence to ISO 10993-1 and ISO 10993-5 (for cytotoxicity).
- Historical Data/Predicate Device Comparison: Demonstrating that the device's characteristics are "equal or better" or "similar" to a legally marketed predicate device (Zolid FX, K152383).
8. The Sample Size for the Training Set:
Not applicable. There is no concept of a "training set" for physical material properties or for a device that does not involve machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set.
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