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X-cera Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

X-cera Zirconia Blanks are provided in either block, disc, cylinder shape and are derived from zirconia powder that has been processed via uni-axial die pressing, followed by iso-static pressing, to achieve final net shapes of uniform density and distribution. These Zirconia Blanks can be fabricated into various prosthetic dental device.

X-cera Zirconia Blanks are offered in ten(10) different product families of shapes and a multitude of different sizes as shown in Figure 1 and Table 1 and are capable of being machined into complex dental shapes using modern machining methods and are similar to the sizes and shapes of the predicate device.

The document describes the submission of "X-cera Zirconia Blanks" for 510(k) premarket notification. The information provided outlines the device's technical specifications and a study conducted to demonstrate its substantial equivalence to a legally marketed predicate device, "Aidite Zirconia Dental Ceramics (K111291)".

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on compliance with international standards (ISO 6872, ISO 10993, ISO 7405) and internal design specifications. The reported device performance confirms compliance with these criteria through a series of non-clinical tests.

Note: The document explicitly states "The X-cera Zirconia Blanks passed all testing stated above as shown by the acceptable results obtained." and "The device passed all the testing in accordance with national and international standards."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes for each of the non-clinical tests (Flexural Strength, Density, Shrinkage, Biocompatibility, etc.). It only indicates that "testing has been performed" and the "test results comply."

The data provenance is from non-clinical performance data (laboratory testing) conducted to support the substantial equivalence of the device. The country of origin of the testing is not specified, but the manufacturer is Shenzhen XiangTong Photoelectricity Technology Co., Ltd. in China. The testing would be considered prospective in the context of demonstrating device performance against pre-defined criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

There is no mention of experts being used to establish a "ground truth" in the traditional sense. This is because the study is a non-clinical performance study focusing on material properties and biocompatibility, not on interpretative outcomes like in medical imaging. The ground truth is established by the standards themselves (e.g., ISO 6872 sets the acceptable flexural strength) and the device's design specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As this is a non-clinical material property and biocompatibility study, there is no human interpretation or adjudication involved to establish ground truth or assess performance in the way described by adjudication methods for clinical studies.

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

No MRMC comparative effectiveness study was done. This type of study is irrelevant for a device like "X-cera Zirconia Blanks," which is a material for dental prosthetics and does not involve human readers or AI assistance in diagnostic interpretation.

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

No standalone algorithm performance study was done. This device is not an algorithm or an AI-powered system, so this type of study is not applicable. The performance evaluated is of the physical and chemical properties of the material itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical performance tests is based on:

1. International Standards: Specifically, ISO 6872 for dental ceramic materials, ISO 10993 for biological evaluation of medical devices, and ISO 7405 for preclinical evaluation of medical devices used in dentistry. These standards define acceptable ranges or minimum/maximum values for properties like flexural strength, density, and biocompatibility.
2. Product Design Requirements: Internal specifications set by the manufacturer (e.g., flexural strength ≥ 900MPa).
3. Manufacturer's Specified Values: Values stated for the device in the Instruction for Use (e.g., for density and porosity).

8. The sample size for the training set

Not applicable. This device is a material, not a machine learning algorithm, therefore there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth established for it.

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