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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):

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