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Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with many CAD/CAM or manual milling machines. Vericore zirconia blanks are biocompatible and designed to fabricate;

• Zirconia Substructures .
• -Restorations (Including inlays, onlays, and veneers)
• . Crown Framework in the Anterior and Posterior regions
• . Bridge Framework in the Anterior and Posterior regions

Vericore Zirconia Blanks is a device made from pre-sintered zirconia powder. It is available in various shades, shapes, and sizes to accommodate the customers CAD/CAM or manual milling equipment/strategies and is not machine specific. Vericore Zirconia Blanks are made from a biocompatible zirconia powder. It is intended to be used by professionals for the fabrication of dental restorations.

The provided text is a FDA 510(k) premarket notification for a dental device, "Vericore Zirconia Blanks". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of a device's performance against specific acceptance criteria in a clinical setting. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment for a clinical study is not available in the provided text.

However, I can extract information related to the bench testing conducted.

Here's a breakdown of the available information:

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

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

• Sample Size: Not specified for the bench tests.
• Data Provenance: Not specified, but generally, bench testing data for medical devices would originate from the manufacturer's testing facilities (likely in the USA, given the applicant's address). The tests are prospective in nature as they are conducted for this specific submission.

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)

• Not applicable. Bench testing does not typically involve human experts for establishing ground truth as it measures material properties based on established standards.

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

• Not applicable. Bench testing does not involve adjudication.

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, an MRMC comparative effectiveness study was not done. This document is for a physical dental material, not an AI-powered diagnostic device.

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

• No, a standalone performance study was not done. This document is for a physical dental material, not an algorithm.

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

• For the bench tests (Flexural Strength, Chemical Solubility, Density), the "ground truth" is based on established international standards (ISO 6872) for material properties.

8. The sample size for the training set

• Not applicable. This is a physical dental material, not a machine learning algorithm, so there is no "training set."

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

• Not applicable. There is no training set for a physical dental material.

In summary, the provided document details the regulatory submission for a dental material (Vericore Zirconia Blanks). The "study" described refers to bench testing to ensure the material meets specified physical and chemical properties according to international standards (ISO 6872). It does not involve a clinical study with human subjects, expert readers, or AI performance metrics.

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Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with CAD/CAM or manual milling machines. Vericore zirconia blanks are biocompatible and designed to fabricate;

• -Zirconia Substructures
• Restorations (Including inlays, onlays, and veneers) -
• -Crown Framework in the Anterior and Posterior regions
• -Bridge Framework in the Anterior and Posterior regions

Vericore Zirconia Blanks is a device made from pre-pressed and pre-sintered zirconia powder. It is available in various shades, shapes, and sizes to accommodate the customers CAD/CAM or manual milling equipment/strategies and is not machine specific. Vericore Zirconia Blanks are made from a biocompatible zirconia powder. It is intended to be used by professionals for the fabrication of dental restorations.

The provided document is a 510(k) summary for a medical device (Vericore Zirconia Blanks), which primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting a detailed clinical study for novel device performance. Therefore, many of the requested fields related to clinical study design (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance with AI) are not applicable or findable in this type of submission.

However, I can extract information related to acceptance criteria, device performance, and limited testing details.

Here's the information based on the provided document:

Acceptance Criteria and Device Performance

Study Details

• Sample size used for the test set and the data provenance: Not explicitly stated for the "test set" in the context of a clinical performance study. The "test set" here refers to the samples of Vericore Zirconia Blanks that underwent bench testing. The provenance of these physical samples would be the manufacturer (Whip Mix Corporation).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a material, and its performance is evaluated through physical and chemical property testing (bench testing) against international standards, not against expert human interpretations.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Performance is determined by objective measurements compared to standard thresholds, not by human adjudication of clinical outcomes.
• 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. This is not an AI-enabled diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI-enabled device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the bench tests are the established performance requirements outlined in the ISO 6872 standard for dental ceramic materials and ISO 10993 for biocompatibility.
• The sample size for the training set: Not applicable. This device is a material, not a machine learning model.
• How the ground truth for the training set was established: Not applicable. No training set is involved for this device.

Additional Information from the document:

• Study Type: Bench testing (physical and chemical property evaluation) and comparison to a legally marketed predicate device to establish substantial equivalence.
• Predicate Device: White Peaks Copran ZR/Origin ZR (K092496).
• Basis for Biocompatibility: The document states, "No further biocompatibility tests are necessary because Whip Mix Vericore Blanks are made from the same powder as the predicate," which indicates a reliance on the biocompatibility testing performed for the predicate device (in accordance with ISO 10993-10, 10993-3, and 10993-5).

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