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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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VITA YZ® ST and VITA YZ® XT materials are blanks used for fabricating dental restorations.

VITA YZ® ST is indicated for fully anatomical anterior crowns, multi-unit fully anatomical anterior and posterior bridges, fully anatomical crowns and multi-unit bridges on direct screw-retained restorations, and single-tooth and multi-unit bridge frameworks of anterior and posterior crowns and bridges.

VITA YZ® XT is indicated for fully anatomical anterior and posterior crowns, fully anatomical 3-unit anterior and posterior bridges, and anterior and posterior single-tooth and 3-unit bridge frameworks.

VITA YZ ST and VITA YZ XT discs are pre-sintered zirconia materials, partially stabilized with yttrium oxide (Y-TZP, yttria stabilized tetragonal zirconia polycrystal). VITA YZ ST is made of Super Translucent Zirconia and VITA YZ XT is made of Extra Translucent Zirconia. They offer higher translucency to better match natural dentition.

This document describes the premarket notification (510(k)) for two dental materials, VITA YZ ST and VITA YZ XT (zirconia blanks for fabricating dental restorations).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative sense for all attributes. Instead, it refers to meeting specific international standards and demonstrating "similar" properties to predicate devices. For mechanical strength, a direct comparison is given.

Note: For many criteria, the "performance" is stated as meeting a standard or being "similar" rather than a specific numerical result. The flexural strength is the most quantitative comparison provided. The conclusion explicitly states that "The differences between VITA YZ ST & VITA YZ XT and the predicate devices do not impact safety and effectiveness, as VITA YZ ST & VITA YZ XT share same indications as the predicate devices, meet the same biocompatibility, and ISO 6872 test criteria."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical data or human-derived data. All performance testing described is non-clinical (bench testing) and biocompatibility testing.

• Sample Size for Bench Tests: Not explicitly stated for flexural strength or other mechanical/physical properties. Standard testing methods (e.g., ISO 6872) typically define minimum sample sizes for such tests.
• Data Provenance: The data is generated from non-clinical bench testing. The country of origin for the testing is not specified, but the applicant (VITA Zahnfabrik H.Rauter GmbH Co.) is located in Germany.
• Retrospective or Prospective: Not applicable as no clinical data or human studies were conducted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. "Ground truth" in the context of clinical diagnosis or interpretation by experts is not relevant here, as this is a materials science evaluation and not a diagnostic device. The "truth" is established by conformance to international material standards and laboratory measurements.

4. Adjudication Method for the Test Set

Not applicable, as no expert adjudication involving human readers/interpreters was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The device is a dental material, not a diagnostic or AI-assisted diagnostic device. The study focused on material properties and biocompatibility.

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

Not applicable. This device is a material for fabricating dental restorations, not an algorithm.

7. The Type of Ground Truth Used

• For material properties (e.g., flexural strength, compliance with ISO 6872): The "ground truth" is defined by the requirements of the international standards (e.g., ISO 6872) and measurable physical properties determined through laboratory testing using standardized methodologies.
• For biocompatibility: The "ground truth" is established by conformance to the requirements of the international standards for biocompatibility (ISO 10993-1 and ISO 7405) through specific biological evaluation tests.

8. The Sample Size for the Training Set

Not applicable. No "training set" in the context of machine learning or AI development was used, as this is a material science product.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set was used.

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