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Aidite Zirconia Dental Ceramics are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

Aidite Zirconia Dental Ceramics are derived from zirconia powder that has been processed via uni-aixial die pressing, followed by iso-static pressing, to achieve various shapes of uniform density and distribution. The ceramic blocks can be fabricated into various prosthetic dental devices.

The provided document is a 510(k) summary for Aidite Zirconia Dental Ceramics. It explicitly states that "Clinical testing was not performed for Aidite Zirconia Dental Ceramics as part of the Pre-market Notification requirements for this submission, as dental ceramics that fall under FDA product code EIH have a long history of safe and effective use in the US."

Therefore, the device's acceptance criteria are demonstrated through physical, chemical, and biocompatibility testing against established international standards and by demonstrating substantial equivalence to a predicate device, rather than through a clinical study with human subjects.

Here's a breakdown of the requested information based on the document:

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

The acceptance criteria are implicitly defined by the physical and mechanical properties of dental ceramics and the requirements of the predicate device, as well as the ISO standards mentioned. The document provides the device's reported physical and mechanical properties.

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 applicable as no clinical test set was used. The testing referenced falls under material characterization. The document states: "Aidite Zirconia Dental Ceramics have been tested for their physical and chemical properties in accordance with ISO 6872 and BS EN 1641, as well as biocompatibility in accordance with ISO 10993-1." The testing would have been done retrospectively on samples of the manufactured material. The country of origin for the manufacturing of the device is China. The raw materials are sourced from Japan.

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)

Not applicable, as no clinical test set or ground truth established by experts was used. The ground truth for material properties is established by recognized international standards (ISO, BS EN).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set requiring expert adjudication was used.

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, as this device is a dental material, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was performed.

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

Not applicable, as this device is a dental material, not an algorithm.

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

The "ground truth" for the device's performance is compliance with established international standards for physical, chemical, and biocompatibility properties of dental ceramics. This is determined through standardized laboratory testing, rather than expert consensus on clinical cases, pathology, or outcomes data, as no clinical study was performed.

8. The sample size for the training set

Not applicable, as no algorithm or training set was involved.

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

Not applicable, as no algorithm or training set was involved.

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