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510(k) Data Aggregation
(135 days)
ZMAXX Dental Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Dental Zirconia Blank is available in various specifications, which are combinations of height (1225mm), color model (0M1/A1 A3/B1B4/C1C4/D2~D4) and transparency model (T45).
This document describes the 510(k) premarket notification for ZMAXX Dental Zirconia Blanks (K191631). It does not pertain to an AI/ML powered medical device, therefore many of the requested categories (such as experts, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable.
Here's the information directly related to the acceptance criteria and study as presented:
Acceptance Criteria and Device Performance for ZMAXX Dental Zirconia Blanks (K191631)
This submission is for a medical device (ZMAXX Dental Zirconia Blanks) which is a physical material used for dental restorations, not an AI/ML software device. Therefore, the "acceptance criteria" and "device performance" are primarily based on meeting established industry standards for dental ceramic materials and demonstrating bio-compatibility, rather than performance metrics typically associated with AI/ML systems (e.g., accuracy, sensitivity, specificity).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by compliance with relevant ISO standards and a comparison to a predicate device.
| Characteristic / Test | Acceptance Criteria (Implicit from Standards/Predicate) | Reported Device Performance (ZMAXX Dental Zirconia Blanks) |
|---|---|---|
| Performance Test (per ISO 6872:2015) | Comply with ISO 6872:2015, Dentistry-Ceramic materials (e.g., strength requirements for Type II Class 5) | Comply with ISO 6872 (specifically, it is Type II Class 5) |
| Density Test | Comparable to predicate device (6.00 g/cm³) | 6.00 g/cm³ |
| Cytotoxicity (per ISO 7405:2008) | No adverse reaction identified | Tested; no adverse react identified |
| Intracutaneous Reactivity (per ISO 10993-10:2010) | No adverse reaction identified | Tested; no adverse react identified |
| Sensitization (per ISO 10993-10:2010) | No adverse reaction identified | Tested; no adverse react identified |
| Acute Systematic Toxicity (per ISO 10993-11:2006) | No adverse reaction identified | Tested; no adverse react identified |
| Genotoxicity (per ISO 10993-3:2014) | No adverse reaction identified | Tested; no adverse react identified |
| Chemical Composition (Weight %) | ZrO₂ >99.0%, Inorganic Pigment (Al₂O₃, SiO₂, Fe₂O₃, Er₂O₃) < 1% | ZrO₂ >99.0%, Inorganic Pigment (Al₂O₃, SiO₂, Fe₂O₃, Er₂O₃) < 1% (predicate: Fe₂O₃, Er₂O₃ ≤ 1%) |
| Crystal Morphology | Tetragonal (matching predicate) | Tetragonal |
| Sintering Temperature | 1500 ± 50°C (matching predicate) | 1500 ± 50°C |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test mentioned (e.g., how many samples were tested for density, or how many biological samples for cytotoxicity). The tests conducted are non-clinical, primarily material and biological safety tests performed in a laboratory setting. The data provenance is implied to be from the manufacturer's internal testing or third-party laboratory testing, with no mention of country of origin for the specific test data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
N/A. This is a material science and biocompatibility assessment, not an AI/ML diagnostic or prognostic system requiring expert ground truth for image interpretation or similar tasks. Compliance with ISO standards and lab test results serve as the "ground truth."
4. Adjudication Method for the Test Set
N/A. Not applicable for material and biocompatibility testing. The "adjudication" is essentially the determination of compliance with the specified test methodology and acceptance criteria of the relevant ISO standards.
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
N/A. This is not an AI/ML device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for the performance and safety of the ZMAXX Dental Zirconia Blanks is based on:
- Compliance with International Standards: Specifically, ISO 6872:2015 for ceramic materials and various ISO 10993 series standards for biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systematic Toxicity, Genotoxicity).
- Predicate Device Comparison: The characteristics and performance (e.g., density, chemical composition, crystal morphology, sintering temperature) are compared to a legally marketed predicate device (Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, K160367).
8. The Sample Size for the Training Set
N/A. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
N/A. This is not an AI/ML device.
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