Search Results

The Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia are intended for use with CAD/CAM technology to produce all ceramic dental restorations (full contour crowns, bridges, inlays, and Veneers) as prescribed by a dentist.

The Dental Zirconia are intended for use with CAD/CAM technology to produce all ceramic dental restorations as prescribed by a dentist.

The Dental Zirconia divided into two categories: Unshaded (Model: DUT) and Pre-Shaded (Model: DUTC).

Both Unshaded Dental Zirconia (Model: DUT) and Pre-Shaded Dental Zirconia (Model: DUTC) are available in discs shape, and in various specifications, which are shares same diameter (98 mm) and combinations of height (10-25 mm).

The color model for pre-shaded dental zirconia includes A1; A2; A3; A3.5; B2; C2; 1M1; 1M2; 2L1.5; 2M2; 3M2; 3M3; 4M2; 5M3 for difference color.

Both Unshaded Dental Zirconia (Model: DUT) and Pre-Shaded Dental Zirconia (Model: DUTC) have same base materials and derived from zirconia powder that has been processed via uni-aixial die pressing, followed by isostatic pressing, to achieve various shapes of uniform density and distribution. The ceramic blocks can be fabricated into various prosthetic dental devices.

The zirconia powder of Dental Zirconia is composed of ZrO2+Y2O3+HfO2+Al2O3. The performance of the Dental Zirconia conforms to ISO 6872:2015 Dentistry: Ceramic Materials.

The Dental Zirconia are disposable device, and provided as non-sterile

This document is a 510(k) premarket notification for a medical device called "Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia". It describes the device, its intended use, and demonstrates its substantial equivalence to a predicate device.

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not explicitly stated in the provided document for each specific test. The document generally states "Non clinical tests were conducted to verify that the proposed device met all design specifications". The tests performed (Cytotoxicity, Oral Mucosa Irritation, Acute Systemic Toxicity, Sensitization, Bacterial Reverse Mutation) typically involve specific sample sizes relevant to the biological or material testing methodology, which are not detailed here.
• Data provenance: Not explicitly stated. However, the tests were conducted by the manufacturer, Qinhuangdao Audental Metal Technology Co., Ltd. in China, or by a testing facility commissioned by them. Given the context of a 510(k) submission, these would be considered prospective tests performed specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This document does not describe the use of human experts to establish "ground truth" for the performance of the device in the way one might for an AI/ML device in clinical settings. The "ground truth" for this device (dental zirconia) is established by its adherence to internationally recognized material and biocompatibility standards (e.g., ISO 6872, ISO 10993 series). The expertise involved would be in the form of certified laboratories and their technical staff, who conduct the tests and interpret results against the established criteria of these standards. The qualifications of these individuals are implied by their affiliation with accredited testing facilities competent in performing these specific ISO standard tests.

4. Adjudication method for the test set:

Not applicable in the context of this device and testing. The compliance with ISO standards is typically assessed through objective measurements and comparison against predefined thresholds specified in the standards, rather than expert adjudication in the sense of consensus on subjective interpretations.

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:

Not applicable. This device is a material (dental zirconia) used for manufacturing dental restorations, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. As mentioned, this is a physical medical device (dental zirconia), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance is established by objective material and biological test results directly measured and compared against the predefined requirements and thresholds of international standards (ISO 6872:2015 and ISO 10993 series). This differs from "expert consensus," "pathology," or "outcomes data" typically used for diagnostic or predictive algorithms.

8. The sample size for the training set:

Not applicable. This device is a material, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. No training set is involved.

Ask a specific question about this device