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Topzir 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.

Topzir 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.

Topzir 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.

The provided document describes the FDA's 510(k) clearance for the Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank. This is a material for dental restorations, not an AI/ML powered medical device. Therefore, many of the requested fields related to AI/ML device studies (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this submission.

The acceptance criteria and device performance are primarily evaluated through non-clinical bench testing and biocompatibility testing against established international standards.

Here's a summary based on the provided text, indicating where information is not applicable (N/A) for a material device:

Acceptance Criteria and Reported Device Performance (Non-Clinical Bench Testing & Biocompatibility)

The device's performance was evaluated against ISO 6872:2015 (Dentistry - Ceramic materials) and ISO 10993:2018 (Biological evaluation of medical devices) series and ISO 7405:2018 (Dentistry - Evaluation of biocompatibility of medical devices used in dentistry).

Table of Acceptance Criteria and Reported Device Performance

Study Details (as applicable for a material device):

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify the exact sample sizes (number of blanks/specimens) used for each physical/mechanical bench test. For biocompatibility, animal models were used (e.g., L-929 cells for cytotoxicity, Syrian hamsters for oral mucosa irritation, guinea pig for skin sensitization, rats for subacute toxicity, ICR mice for acute systemic toxicity, CHL cells for gene mutation, and rabbits for muscle implant).
   • Data Provenance: The document does not explicitly state the country of origin for the testing itself, but the manufacturer is based in Guangzhou, China. The testing appears to be conducted in a laboratory setting per international standards (ISO). The testing is prospective for the purpose of demonstrating substantial equivalence.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. This is a material device. Ground truth is established by adherence to standardized testing protocols and objective measurements according to ISO standards, performed by qualified laboratory personnel, rather than expert consensus on diagnostic images or clinical outcomes.

3. Adjudication method for the test set:

   • N/A. As above, the evaluation is based on objective measurements against ISO standards, not subjective interpretation requiring adjudication.

4. 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:

   • N/A. This is not an AI/ML device.

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

   • N/A. This is not an AI/ML device.

6. The type of ground truth used:

   • For physical/mechanical tests: Objective measurements against the specifications outlined in ISO 6872:2015.
   • For biocompatibility tests: Laboratory results from in vitro and in vivo studies, evaluated against the criteria of the respective ISO 10993 and ISO 7405 standards.

7. The sample size for the training set:

   • N/A. This is not an AI/ML device; there is no "training set" in this context. The manufacturing process of the material is established and validated, but not "trained" in the AI sense.

8. How the ground truth for the training set was established:

   • N/A. As above, there is no training set. The quality control and manufacturing parameters for the material production are established through standard chemical engineering and materials science principles, aiming to consistently produce a material that meets the performance and biocompatibility specifications.

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