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Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed thought dental laboratories or by dental professionals.

Upcera Dental Zirconia Blanks are derived from Zirconia powder that has been processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/ onlay. The zirconia powder is composed of ZrO2 + Y2O3 + HfO2 + Al2O3 with its composition conforms to ISO 13356, Implants for Surgery -- Ceramic Materials Based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry: Ceramic Materials.

Upcera Dental Zirconia Pre-Shaded Blanks are derived from the same Zirconia powder as the regular Upcera Dental Zirconia Blanks, with the addition of very small amount of inorganic pigments, before the composite material is processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/ onlay. The purpose of the inorganic pigments is to generate the color on the prosthetic dental devices, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the pre-shaded dental zirconia blanks conforms to ISO 6872: 2008, Dentistry: Ceramic Materials.

The document describes the submission of a 510(k) premarket notification for "Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank." The primary goal of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (K093560, "Upcera Zirconia Blanks"). The acceptance criteria and the study used to demonstrate that the device meets these criteria are primarily based on international standards for dental materials.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the specified ISO standards, and the reported performance indicates compliance with these standards.

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

• Sample Size: Not explicitly stated in the provided text. The document mentions "Bench testing was performed per ISO 6872:2008 and internal procedures" and "Biocompatibility testing was performed to verify the equivalent safety of the materials that are used," as well as "Tests were conducted following the recommended procedures outlined in the FDA recognized consensus standard of ISO 10993." These standards typically specify sample sizes for their respective tests, but the specific number of samples tested for this submission is not detailed.
• Data Provenance: The studies were conducted by the manufacturer, Liaoning Upcera Company Limited, based in China (Liaoning Upcera Co., Ltd, No.122 Xianghuai Road, Economic Development Zone, Benxi, Liaoning, China). The data appears to be prospective as it was generated specifically for this 510(k) submission to demonstrate the device's properties.

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

This information is not applicable and not provided. This submission concerns material properties and biocompatibility as per international standards, not the interpretation of medical images or diagnostic outputs where expert consensus would typically be required for ground truth. The "ground truth" here is defined by meeting predefined technical specifications and safety profiles established by ISO standards.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As explained above, the "ground truth" is based on objective measurements against ISO standards. There is no mention of human-based adjudication for these types of material tests.

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

This information is not applicable and not provided. An MRMC study is relevant for diagnostic imaging devices where human readers interpret results, often with AI assistance. This submission is for a dental material (zirconia blanks) and does not involve AI or human interpretation in that context.

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

This information is not applicable and not provided. This device is a material, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for both mechanical properties and biocompatibility is defined by international consensus standards:

• For mechanical properties (flexural strength, radioactivity, density), the ground truth is established by the requirements and test methods outlined in ISO 6872:2008, Dentistry: Ceramic Materials.
• For biocompatibility, the ground truth is established by the requirements and test methods outlined in ISO 10993 series (specifically ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006, ISO 10993-3:2003).
• For material composition, the ground truth is established by ISO 13356, Implants for Surgery -- Ceramic Materials Based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP).

8. The Sample Size for the Training Set

This information is not applicable and not provided. "Training set" is a concept typically associated with machine learning or AI models. This device is a physical material, and its performance is evaluated through direct testing against established material standards, not through training a model.

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

This information is not applicable and not provided for the same reasons as #8.

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