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Kingcera Dental Zirconia Blanks are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.

Kingcera Dental Zirconia Blanks are derived from zirconia powder that has been processed through various molding and sintering techniques - into their final net shapes. These blanks are further fabricated into various all-ceramic restorations such as crowns, bridges, veneers, and inlay/onlay. The zirconia powder is composed of ZrO2, HfO2, Y2O3, and other oxides; the performance of the Kingcera Dental Zirconia Blanks conforms to ISO 6872-2015. Dentistry: Ceramic Materials. Kingcera Dental Zirconia Blanks are ceramic dental blanks designed to manufacture ceramic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic devices are intended for single-use applications. At the dental lab, the blanks are held to t. Kingcera Dental Zirconia Blanks are supplied in different shapes, such as blocks, discs, rods, or customized shapes. They are provided in combinations of ninety-nine different colors and a gradual-changing translucency effect. The different constituents of color additives (such as Fe2O3); the different translucencies originate from a slight difference in the amount of Y203.

I am unable to provide the information you requested. The document you provided is an FDA 510(k) clearance letter and a 510(k) summary for a dental zirconia blank. This document describes the device, its intended use, and confirms its substantial equivalence to a predicate device based on non-clinical performance data.

However, the questions you asked pertain to the acceptance criteria and study details for an AI/ML-based medical device, specifically regarding:

• A table of acceptance criteria and reported device performance
• Sample size and data provenance for a test set
• Number and qualifications of experts for ground truth establishment
• Adjudication method
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth (e.g., pathology, outcomes data)
• Training set sample size and ground truth establishment

These types of details are typically found in the submission package for an AI/ML medical device, which would include extensive performance testing, clinical study data, and a detailed description of the AI model's development and validation. The provided document for a dental zirconia blank does not contain any information related to AI/ML, clinical studies with human readers, ground truth establishment by experts, or any of the other specific criteria you've outlined for an AI/ML device. The performance data mentioned for the dental blank relates to its material properties (e.g., flexural strength, chemical solubility) as per ISO standards.

Therefore, I cannot extract the requested information from the provided text.

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