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510(k) Data Aggregation
(63 days)
VITA YZ MULTI TRANSLUCENT is indicated for:
- · fully anatomical anterior and posterior crowns
- · fully anatomical 4 unit anterior and posterior bridges
- · fully and partially veneered single tooth and up to 4-unit bridge substructures in the anterior and posterior tooth regions
- · inlays
- · Onlays
- · veneers
VITA YZ MULTI TRANSLUCENT are zirconia blanks for reliable shade reproduction. They can be used for the production of fully and partially veneered reconstructions and monolithic bridge restorations in the anterior and posterior tooth regions. VITA YZ MULTI TRANSLUCENT is part of the VITA YZ SOLUTIONS product group.
The provided document is a 510(k) Premarket Notification from the FDA for a dental material, VITA YZ MULTI TRANSLUCENT. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive details on a comprehensive standalone study with specific acceptance criteria, ground truth, and human reader performance that would be typical for an AI/ML medical device.
Therefore, many of the requested details about acceptance criteria, study design (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance), and ground truth establishment are not directly available in this document as it pertains to a material rather than an AI/ML algorithm.
However, I can extract the acceptance criteria and performance data available for the material's properties, as this document focuses on non-clinical testing of the material itself.
Here's the information that can be extracted, interpreted in the context of the material's performance:
1. Table of Acceptance Criteria and Reported Device Performance (for the material's properties):
| Test Parameter | Acceptance Criteria | Reported Device Performance (VITA YZ MT) |
|---|---|---|
| Flexural Strength | > 800 MPa | 922 ± 95 MPa |
| Linear Coeff. of Thermal Expansion (CTE) | Within manufacturer's specified range (9.8 - 10.8 x 10-6 K-1 for VITA YZ ST Multicolor) | 10.4 × 10-6 K-1 |
| Chemical Solubility (Weight Loss) | < 100 µg/cm² | 0 µg/cm² |
| Radioactivity (Uranium-238) | ≤ 1.0 Bq/g | ≤ 1.0 Bq/g |
| Packaging, Marking, Labeling | Compliance with EN ISO 6872:2019 | Compliant (Visual inspection) |
| Uniformity | Even distribution, no segregation of pigments | Compliant (Visual inspection) |
| Freedom from Extraneous Materials | Absence of foreign material | Compliant (Visual inspection) |
| Biocompatibility | No adverse biological effects | Verified (According to DIN EN ISO 10993-1 and DIN EN ISO 7405) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated for each test, but standard material testing typically involves multiple samples for statistically significant results. The summary mentions "tested samples" without providing the exact number for each parameter (e.g., number of flexural strength specimens).
- Data Provenance: The tests were conducted according to EN ISO 6872 standards for dental ceramic materials. The radioactivity test was performed at Jülich Forschungszentrum. These are typically laboratory-based, controlled material property tests, not based on patient data provenance.
- Retrospective/Prospective: Not applicable, as these are material property tests, not clinical studies on patient outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Experts: Not applicable. For material property tests, "ground truth" is established through standardized physical and chemical measurements (e.g., using calibrated instruments for flexural strength, spectrometers for chemical composition, etc.) as defined by international standards like EN ISO 6872. These are objective measurements rather than subjective expert interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. Material property tests rely on objective measurements and established scientific protocols for data collection and analysis, not on expert consensus or adjudication.
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:
- MRMC Study: No. This is a material, not an AI/ML device, so MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For these material tests, the "ground truth" is defined by the physical and chemical properties as measured by validated testing methods adhering to international standards (e.g., EN ISO 6872). It is based on objective laboratory measurements, not expert consensus, pathology, or patient outcomes data.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is a manufactured material, not an AI/ML algorithm that requires a training set. The "development" of the material would involve iterative formulation and testing, but not a "training set" in the AI/ML sense.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, for the same reasons as #8.
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