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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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The ComfortSoft® Soft Denture Liner System is intended for use as a long-term soft liner for removable dentures.

ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term use in removable dentures. ComfortSoft® is suitable for all PMMA-based dentures. Meets ISO 10139-2 and is a Shors A hardness Type A material. It is a, translucent, non-flowing, long-term soft silicone based liner. Use to reline, rebase or line new or existing dentures. ComfortSoft® Soft Denture Liner provides a cushion between the denture and the mouth tissues to aid in reducing sore spots, and allows improved adaptation to tissue contours thereby aiding in a comfortable fit of the denture.

Here's a breakdown of the acceptance criteria and study information for the ComfortSoft® Soft Denture Liner System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the individual biocompatibility tests or the ISO 10139-2 testing. It only reports that these tests were "completed and passed."

The data provenance is not explicitly mentioned (e.g., country of origin). The studies appear to be pre-market bench and biological testing conducted by or for the manufacturer. No retrospective or prospective human clinical trial data is mentioned.

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

This information is not applicable. The evaluations conducted were physical and biological tests against established standards (ISO 10139-2) and biocompatibility guidelines, not subjective expert assessments of a test set. Ground truth was established by the specifications of the tests themselves.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluations were objective tests against standards rather than subjective expert assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on bench testing and biocompatibility.

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

This question is not applicable to a physical medical device like a denture liner. There is no algorithm involved.

7. The Type of Ground Truth Used

The ground truth used for performance validation was based on:

• International Standards: ISO 10139-2:2009 for material properties.
• Biocompatibility Guidelines: Established protocols for various toxicity and sensitization tests (e.g., MEM elution, Guinea Pig Maximization Sensitization).
• Manufacturer Specifications: For bond strength (at least 1 MPa).

8. The Sample Size for the Training Set

This information is not applicable. There is no machine learning "training set" for this type of device.

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

This information is not applicable for the same reason as point 8.

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