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510(k) Data Aggregation
(272 days)
Zmaxx T Series is used in the manufacture of dental prosthetics.
Zmaxx T Series is zirconia-based ceramic provided in various shapes such as round and square and it is used to manufacture cores of all ceramic crowns, and is classified into ISO 6872 Type 2 Class 4. It is used to manufacture ceramic restorations through cutting process by dental MAD/MAM, computer-assisted design system, or CAD/CAM system. The subject device offers three different shades to meet the needs of different patients tooth colors. It also offers various shape types to be used with various jigs for CAD/CAM milling machine.
This document describes the Zmaxx T Series, a zirconia-based ceramic used in the manufacture of dental prosthetics. The submission is a 510(k) summary, aiming to establish substantial equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Zmaxx T Series are based on conformity to international standards, primarily ISO 6872 for dental ceramics, and ISO 10993 for biocompatibility.
| Acceptance Criteria (Standard) | Reported Device Performance (Zmaxx T Series) | Predicate Device 1 (NATURAZ SERIES) Performance | Predicate Device 2 (BruxZir™ Anterior) Performance |
|---|---|---|---|
| ISO 6872 Requirements: | |||
| COE (Coefficient of Thermal Expansion) | $(10.6 \pm 0.5) \times 10^{-6} K^{-1}$ (meeting the ISO 6872 requirement) | $(11.5 \pm 0.5) \times 10^{-6} K^{-1}$ (meeting the ISO 6872 requirement) | $11 \times 10^{-6} K^{-1}$ (meeting the ISO 6872 requirement) |
| Flexural Strength | >600 MPa (meeting the ISO 6872 requirement) | >800 MPa (meeting the ISO 6872 requirement) | >650 MPa (meeting the ISO 6872 requirement) |
| Chemical Solubility | <2000 µg/cm² (meeting the ISO 6872 requirement) | <100 µg/cm² (meeting the ISO 6872 requirement) | <2000 µg/cm² (meeting the ISO 6872 requirement) |
| Freedom of Extraneous Materials, Radiation Emission, Density, Shrinkage Factor | Tested as per ISO 6872; results "support substantial equivalence" (specific values not provided in this summary) | Not explicitly stated in the summary, but implied to meet requirements as a predicate. | Not explicitly stated in the summary, but implied to meet requirements as a predicate. |
| ISO 10993 Requirements (Biocompatibility): | |||
| Cytotoxicity (ISO 10993-5) | Non-toxic and biocompatible (Meeting the ISO 10993-5 requirement) | Non-toxic and biocompatible (Meeting the ISO 10993-5 requirement) | Non-toxic and biocompatible (Meeting the ISO 10993-3, 5, 1 and 10993-11 requirements) - Note: ISO 10993-3 and 10993-1 mentioned for Predicate 2, but not for Subject or Predicate 1 for Cytotoxicity |
| Sensitization & Irritation (ISO 10993-10) | Non-toxic and biocompatible (Meeting the ISO 10993-10 requirement) | Non-toxic and biocompatible (Meeting the ISO 10993-10 requirement) | Not explicitly listed as 10993-10, but covered under "Non-toxic and biocompatible" with other ISOs. |
| Acute Systemic Toxicity (ISO 10993-11) | Non-toxic and biocompatible (Meeting the ISO 10993-11 requirement) | Non-toxic and biocompatible (Meeting the ISO 10993-11 requirement) | Non-toxic and biocompatible (Meeting the ISO 10993-3, 5, 1 and 10993-11 requirements) |
| Other Bench Testing: | |||
| Visual Inspection, Dimension Accuracy, Package, Uniformity | Tested; results "support substantial equivalence" (specific values not provided in this summary) | Not explicitly stated in the summary. | Not explicitly stated in the summary. |
| ISO 13356 Mono Clinic Phrase Rate | Tested; results "support substantial equivalence" (specific values not provided in this summary) | Not explicitly stated in the summary. | Not explicitly stated in the summary. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of units or specimens) used for each of the non-clinical tests (e.g., flexural strength, chemical solubility, biocompatibility). It only states that "All the test results support substantial equivalence to the predicate devices."
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied that the testing was conducted by the manufacturer, Maxx Digm, Inc., or its contract manufacturer (DMAX Co., Ltd.) to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This document describes a non-clinical performance and biocompatibility study for a dental material (zirconia-based ceramic). It does not involve human subjects, image analysis, or diagnostic tasks that would typically require independent expert review or "ground truth" establishment in the way described (e.g., radiologists interpreting images). The "ground truth" for this device's performance is established by the specified ISO standards and the quantitative measurement methods outlined within those standards.
4. Adjudication Method for the Test Set
Not applicable. The study is a non-clinical laboratory evaluation against specified ISO standards and does not involve subjective interpretations or the need for adjudication among multiple reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a non-clinical evaluation of a medical device material against established performance standards and predicate devices. MRMC studies are typically used for diagnostic devices that involve human interpretation of clinical data (e.g., images).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in essence. The performance testing described is "standalone" in that it assesses the physical, chemical, and biological properties of the material itself, independent of human interaction in its final clinical application (beyond the standardized testing procedures). This is not an algorithm, but rather a material's intrinsic properties.
7. The Type of Ground Truth Used
The ground truth for this study is based on established international standards (ISO 6872, ISO 10993-5, ISO 10993-10, ISO 10993-11). These standards define the acceptable ranges and methodologies for evaluating dental ceramic materials for properties such as flexural strength, thermal expansion, chemical solubility, and biocompatibility.
8. The Sample Size for the Training Set
Not applicable. This is a non-clinical performance study of a material and does not involve machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set involved, the concept of establishing ground truth for it does not apply.
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