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510(k) Data Aggregation
(59 days)
UltraThineer Zirconia Slurry is indicated for use by dental technicians in the construction of custommade ceramic restorations. These include copings, crowns, inlays and onlays, veneers, and bridges (3-unit anterior bridges).
The UltraThineer Zirconia Slurry is a ceramic slurry intended for use in fabricating custom-made ceramic restorations using 3D printing and sintering processes. There is a single formulation: Zirconia-5Y/BMF-5YZ-1.6B. The UltraThineer Zirconia Slurry is provided as a slurry contained in a sealed tamper-proof and opaque HDPE bottle, with product labeling. The bottle containing the slurry has dimensions of 3.5" in diameter and 7.75" in height and has a maximum volume of 0.75L. For use, the slurry is poured into a vat inside the 3D printer for printing the dental veneer. After printing, the veneer is sintered to yield the final product. Each veneer will be custom fabricated on a named patient prescription basis on the order of a dentist.
The provided text describes a 510(k) premarket notification for a medical device called "UltraThineer Zirconia Slurry (5Y-B)". This document primarily focuses on demonstrating substantial equivalence to a predicate device, not on presenting a study proving the device meets specific acceptance criteria in the manner of a clinical trial for an AI/software device.
Therefore, many of the requested details about acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, and standalone performance are not applicable to this type of regulatory submission because it is for a material (zirconia slurry) and not an AI/software device.
However, I can extract the relevant "acceptance criteria" (performance parameters) and "reported device performance" from the Non-Clinical Performance Data (Bench Testing) and Biocompatibility Testing sections as the "study" that proves the device meets these criteria.
Here's the breakdown of the information that can be extracted, and where the information is absent or not relevant for this type of submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Parameter) | Reported Device Performance (UltraThineer Zirconia Slurry) |
|---|---|
| Biocompatibility (ISO 10993-1) | Met biocompatibility requirements (Chemical Characterization, Cytotoxicity, Sensitization, Oral Mucosal Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity) |
| Radioactivity (ISO 6872:2015) | Activity concentration of uranium238 less than 1.0 Bqg-1 (meeting ISO 6872 requirements) |
| Flexural Strength (ISO 6872:2015) | >300 Mpa (meeting ISO 6872 requirements) |
| Linear Thermal Expansion Coefficient (ISO 6872:2015) | Mean linear thermal expansion coefficient within 0.5 x 10^-6 K^-1 of the value reported by the manufacturer (meeting ISO 6872 requirements) |
| Chemical Solubility (ISO 6872:2015) | < 100 µg/cm² (meeting ISO 6872 requirements) |
| Shelf-Life Testing | Met the requirements of the standard |
| ISO 6872 Type/Classification | Type 1 / Class 3 |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document as it's a 510(k) summary for a material, not a clinical study or AI/software validation. The bench testing involved physical and chemical property measurements on samples of the zirconia slurry.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable. Ground truth, in the context of expert consensus, is typically relevant for interpretative devices (like AI for image analysis). For material testing, "ground truth" is defined by the objective measurement according to established international standards (like ISO 6872 and ISO 10993-1).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used in clinical trials or expert review processes, which are not detailed for the material property testing described.
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 is not applicable. This type of study is specifically for AI-enabled diagnostic or assistive software, not for dental materials.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This term refers to the performance of an AI algorithm directly, which does not apply to a physical dental material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance criteria for this device (a material) is based on International Standards such as ISO 6872:2015 for ceramic materials and ISO 10993-1 for biological evaluation of medical devices. The device's properties were measured and compared against the defined thresholds and methodologies within these standards.
8. The sample size for the training set
This is not applicable. The concept of a "training set" is relevant for machine learning/AI algorithms that learn from data. This document describes a physical material, not an AI system.
9. How the ground truth for the training set was established
This is not applicable for the reason stated in point 8.
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