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Dental Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers. All Blocks are processed through dental laboratories or by dental professionals.

The proposed device, Dental Zirconia Blocks, are derived from zirconia powder, usually using CAD / CAM (computer aided design / computer aided manufacturing) method of making all-ceramic restorations such as crowns.bridges.veneers.inlay, with high strength, hardness, good resistance to fracture toughness and wear resistance. They are available in different models that differ in various specification and color. Two main models for Dental Zirconia Block are CMW series and CMC series in which CMW series represents the White Zirconia(W1,W2 and W3) and the CMC series represents the Color Zirconia (A1,A2,A3,A3.5,A4,B1,B2, B3,B4,C1,C2,C3,C4,D1,D2,D3,D4,T1,T2 and T3). The white zirconia is composed of ZrO2+HfO2+YzOs and an additional inorganic pigment: Al₂O3 and Other oxide. The colour zirconia are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe2O3 +Pr2O3 +Er2O3. The inorganic pigments generate the color on the prosthetic dental device, after sintering at dental labs, that matches natural color of patient's teeth. The composition of the Dental Zirconia Blocks including the white zirconia and the colour zirconia conforms to ISO 13356:2015, Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials. The Dental Zirconia Blocks are provided as non-sterile.

The provided text describes the 510(k) summary for the "Dental Zirconia Blocks" device (K192262). This document focuses on demonstrating substantial equivalence to a predicate device, rather than performing a clinical study with acceptance criteria for a novel AI/software medical device.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details for an AI/software device cannot be extracted from this document.

This document describes a traditional medical device (dental zirconia blocks) and the testing performed is for physical and chemical properties, as well as biocompatibility, against established international standards.

For completeness, here's a summary of the testing performed and conclusions drawn from the provided text, adapted as much as possible to the prompt's structure, but it's important to reiterate that this is not an AI/software device study.

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against various ISO standards. The document states that the proposed device "met all design specifications" and "complies with" these standards. The "acceptance criteria" are implied by the requirements of these standards.

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New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) are intended for use with CAD/CAM technology to produce all ceramic dental restorations (full contour crowns, bridges, inlays, and Veneers) as prescribed by a dentist.

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded) are derived from Zirconia powder that has been processed into their final net shapes. These blanks are then further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/ onlay. The zirconia powder is composed of ZrO2 + Y2O3 + HfO2 + A12O2. The performance of the dental blanks conforms to ISO 6872: 2008, Dentistry: Ceramic Materials. The shading effects of New Century All-Ceramic Dental Zirconia Blocks (Pre-Shaded) are achieved by blending different zirconia powder material, all from the same supplier; have almost identical composition, differing only in the trace amount of inorganic pigments to achieve the shading effects in dental blanks. The performance of the preshaded dental zirconia blanks also conforms to ISO 6872, Dentistry: Ceramic Materials.

The provided text describes a 510(k) premarket notification for "New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)". This is a submission for a medical device used in dentistry, specifically for CAD/CAM technology to produce dental restorations. It is not a submission for an AI/ML device.

Therefore, most of the questions regarding acceptance criteria, study design for AI devices, sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance are not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device (K140070 Luxer Shaded Zirconia) based on non-clinical performance testing and technological comparison.

However, I can extract the information that is present in the document which relates to performance and criteria.

1. A table of acceptance criteria and the reported device performance:

The document states that bench testing was performed per ISO 6872:2008 and using internal testing procedures (for presintered and sintered density) to ensure that the device met specifications. It explicitly mentions:

"All tests were verified to meet acceptance criteria."

The specific acceptance criteria from ISO 6872:2008 are not detailed in the provided text, but the document confirms compliance. The device also underwent a biocompatibility assessment in accordance with ISO 10993-1.

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

The document does not specify sample sizes for the non-clinical bench tests. The tests were performed "per ISO 6872:2008 and using internal testing procedures." The provenance of the data is implied to be from the manufacturer, Shanghai New Century Dental Materials Co., Ltd. in China, as they performed the tests.

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)

This is not applicable as it is not an AI/ML device requiring clinical expert ground truth for interpretation. The "ground truth" here refers to the measured physical and mechanical properties of the material against established standards (ISO 6872:2008).

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

Not applicable for a non-AI/ML device.

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

Not applicable for a non-AI/ML device.

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

Not applicable for a non-AI/ML device.

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

The "ground truth" for this device's performance is objective measurement against established international standards for ceramic dental materials (ISO 6872:2008) and internal specifications for density.

8. The sample size for the training set

Not applicable for a non-AI/ML device.

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

Not applicable for a non-AI/ML device.

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