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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 through dental laboratories or by dental professionals.

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are derived from zirconia powder that has been processed into their final 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 vttriastabilized tetragonal zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are derived from the same Zirconia powder as the regular Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank 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 dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.

This document is a 510(k) Premarket Notification from the FDA for a dental device. It does not describe an AI/ML device, nor does it include a clinical study or a study comparing device performance against acceptance criteria in the way described in your prompt.

The document pertains to the market clearance of "Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank" manufactured by Zhejiang Zahndent Biotechnology Co., Ltd. and compares it to a predicate device (K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank).

Here's why the requested information cannot be extracted from this document:

• Not an AI/ML Device: The device described is a physical dental material (zirconia blanks) used for restorations. It does not involve any artificial intelligence, machine learning, or software for diagnosis or analysis.
• No Clinical Study: The document explicitly states: "No clinical study is included in this submission" (Section 9). Therefore, there is no study concerning human readers, AI assistance, or comparative effectiveness.
• Bench Testing for Material Properties: The "studies" mentioned are bench tests performed according to ISO standards, focusing on material properties (flexural strength, chemical solubility, biocompatibility, etc.) to demonstrate substantial equivalence to a predicate device. These are not studies evaluating diagnostic performance or a reader's improvement with AI.

Therefore, I cannot provide the information requested in your prompt as it does not align with the content of the provided document. The document primarily focuses on:

1. Device Description: What the dental zirconia blanks are made of and their intended use.
2. Comparison to Predicate Device: Highlighting similarities and minor differences in materials and processing.
3. Non-Clinical Testing Summary: Reporting the results of biocompatibility and performance tests (e.g., cytotoxicity, irritation, sensitization, toxicity, gene mutation, chromosome aberration, muscle implant) to ensure the device meets established material standards (ISO 6872:2015, ISO 13356, ISO 10993, ISO 7405). All these tests "passed," indicating compliance with the relevant standards for material safety and performance.

If you have a document about an AI/ML medical device with clinical study results, I would be able to extract the requested details.

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Dental Zirconia Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.

Dental Zirconia Blank are derived from zirconia powder that has been processed into their final 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 yttriastabilized tetragonal zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872. Dentistry - Ceramic materials.

Dental Zirconia Blank are derived from the same Zirconia powder as the regular Dental Zirconia Blank 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 dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.

The retrieved document is a 510(k) summary for a dental device (Dental Zirconia Blank). It is a regulatory submission demonstrating substantial equivalence to a predicate device, not a study designed to prove the device meets specific performance acceptance criteria for an AI/software product. Therefore, much of the requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this document.

However, the document does contain information about non-clinical testing and general acceptance of these tests based on existing standards.

Here's a breakdown of the relevant information from the document:

1. Table of acceptance criteria and the reported device performance:

The document states that "Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the Dental Zirconia Blank met its specifications. All tests were verified to meet acceptance criteria." While specific numerical acceptance criteria are not tabulated, the document explicitly states that the tests passed these criteria. The relevant tests and their reported performance are:

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 primarily discusses non-clinical bench testing and in vitro and in vivo biocompatibility tests, not a "test set" in the context of an AI/software solution. Therefore, information about a test set sample size or data provenance in that sense is not provided. The biocompatibility tests, however, would have involved animal models (Syrian hamsters, guinea pigs, rats, ICR mice, rabbits), which would constitute the "test set" for those specific biological evaluations. The document does not specify the number of animals used for each test. The testing was conducted by or on behalf of HUNAN CERAMASTER MATERIAL TECHNOLOGY CO.,LTD, located in China. The "provenance" of the data is therefore China. The nature of these tests is prospective for the specific evaluations conducted.

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. This is a material science and biocompatibility assessment for a dental zirconia blank, not an AI/software device requiring expert interpretation for ground truth establishment.

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

Not applicable. This type of adjudication is typically used for human-reviewed data in AI/software evaluations.

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. This document pertains to a physical dental material, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable. This is not an algorithm or software device. Bench testing and biocompatibility studies evaluate the material's properties directly.

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

The "ground truth" for the non-clinical tests is established by recognized international standards (ISO 6872:2015 for material properties, ISO 10993 series and ISO 7405:2018 for biocompatibility). The acceptance criteria outlined in these standards serve as the "ground truth" to determine if the device meets its specifications. For biocompatibility tests, the outcomes observed in the biological test systems (e.g., cell viability, tissue response, animal health) against the defined parameters of the ISO standards constitute the "ground truth."

8. The sample size for the training set

Not applicable. There is no AI algorithm or "training set" involved in the testing described for this dental material.

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

Not applicable. Since there is no training set, this question is not relevant.

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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 through dental laboratories or by dental professionals.

Dental Zirconia Blank are derived from zirconia powder that has been processed into their final 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 yttriastabilized tetragonal zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.

Dental Zirconia Pre-Shaded Blank are derived from the same Zirconia powder as the regular Dental Zirconia Blank 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 dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.

This document describes the premarket notification for the "Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank" device, which is a Class II device (Product Code: EIH). The submission aims to establish substantial equivalence to a predicate device (K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank).

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established international standards for ceramic dental materials and biocompatibility. The reported device performance indicates that the device meets these standards.

2. Sample Size and Data Provenance for Test Set

The document does not provide specific sample sizes for the "test set" in the context of clinical performance or diagnostic accuracy, as this is a material rather than a diagnostic AI device. The testing described is for material properties and biocompatibility.

• Sample Size (Material Properties): Not explicitly stated, but implies a sufficient number of samples were tested to meet the requirements of ISO 6872.
• Sample Size (Biocompatibility): Not explicitly stated, but animals were used for various tests (e.g., Syrian hamsters, guinea pigs, rats, ICR mice, rabbits), indicating standard biological testing protocols.
• Data Provenance: The studies were performed by or for Changsha Honchon Technology Co., LTD, located in China. The provenance of the raw materials (zirconia powder, inorganic pigments) is not specified, but the compliance with ISO standards indicates internationally recognized quality control. The studies are prospective bench and biological tests conducted for the purpose of this submission.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This information is not applicable as the device is a dental material, not a diagnostic device requiring expert interpretation of images or clinical data for ground truth establishment. The "ground truth" for material properties is defined by the objective measurements according to the specified ISO standards, and for biocompatibility by the biological responses observed in controlled animal and in-vitro studies.

4. Adjudication Method for Test Set

This information is not applicable as there is no human interpretation or diagnostic decision-making being assessed that would require adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

This information is not applicable as this is a dental material, not a diagnostic AI device requiring a human-in-the-loop performance study.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable as this is a dental material, not an AI algorithm. The performance studies are entirely standalone in the sense that they evaluate the material itself against predefined criteria.

7. Type of Ground Truth Used

• Material Properties: The "ground truth" is established by objective measurements and analyses against the specifications outlined in ISO 6872:2015 for various material characteristics (radioactivity, flexural strength, chemical solubility, linear thermal expansion coefficient, freedom from extraneous materials, uniformity, shrinkage factor, pre-sintered density, sintered density, and fracture toughness).
• Biocompatibility: The "ground truth" is established by observed biological responses (e.g., cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, local effects) in controlled in-vitro and in-vivo studies conducted according to ISO 10993-1:2018 and ISO 7405:2018, and specific parts of ISO 10993 (e.g., ISO 10993-3, -5, -6, -10, -11).

8. Sample Size for Training Set

This information is not applicable as this device is a material, not an AI-powered device that requires a training set.

9. How Ground Truth for Training Set was Established

This information is not applicable as this device is a material, not an AI-powered device that requires a training set.

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