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priti® multidisc ZrO2 High Translucent are pre-sintered zirconium oxide blanks for use in CNC (Computer Numerical Controls) milling machines to fabricate partial and single anterior and lateral crowns, bridges up to 3 units, inlays, onlays, and veneers for dental prostheses for restoration purposes only.

The priti multidisc ZrOs High Translucent blanks are made of Yttria fully stabilized zirconia (5Y-FSZ Fully Stabilized Zirconia), whereby the increased translucency is due to the higher stabilization of the zirconia base powder with yttrium oxide (Y2O3).

The priti®multidisc ZrO₂ High Translucent blanks are provided as round discs with a diameter of 98.5mm, and varying thicknesses along with 16 VITA color shades, and multicolor versions.

Here's a breakdown of the acceptance criteria and study information for the priti®multidisc ZrO2 High Translucent device, based on the provided FDA 510(k) summary:

This document describes a 510(k) premarket notification for a dental ceramic material, priti®multidisc ZrO2 High Translucent. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices. It is important to note that this document is for a material (zirconia blanks) used to fabricate dental restorations, not a diagnostic AI device. Therefore, many of the typical AI/ML study components (like expert ground truth, adjudication, MRMC studies, training/test sets for algorithms) are not applicable. The "acceptance criteria" here refer to meeting performance standards for the material itself.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the priti®multidisc ZrO2 High Translucent device are based on adherence to the ISO 6872:2015 "Dentistry - Ceramic materials" standard.

Note: The document states that the device "met the standard requirements per ISO 6872:2015" for its classification. Specific numerical values for the performance metrics (e.g., exact flexural strength in MPa) are not provided in this summary, but the general testing categories are listed.

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

Given this is a material science study for dental blanks (not an AI device with a "test set" in the traditional sense):

• Sample Size: Not explicitly stated for each test. The testing was conducted on samples of priti®multidisc ZrO2 High Translucent blanks.
• Data Provenance: Not applicable in the context of patient data. The material itself is manufactured by pritidenta GmbH in Germany.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This is a material testing study, not a study involving human interpretation of medical images or expert consensus for ground truth. The "ground truth" is established by physical and chemical properties measured against a recognized international standard (ISO 6872).

4. Adjudication Method

• Not Applicable. There is no adjudication method described as this is not a study requiring human readers or consensus on diagnostic outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is not relevant for a dental material product. This type of study is typically used for diagnostic or AI-assisted interpretation systems.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not Applicable. This is a material; there is no algorithm or AI component involved.

7. Type of Ground Truth Used

• International Standard (ISO 6872:2015) and Laboratory Measurements. The ground truth is the established performance requirements outlined in the ISO standard for ceramic dental materials. The device's performance is measured in a laboratory setting to confirm it meets these predefined criteria.

8. Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI/ML algorithm.

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

• Not Applicable. As there is no training set.

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