(115 days)
Zirdent 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 thought dental laboratories or by dental professionals.
Zirdent 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.
Zirdent Dental Zirconia Pre-Shaded Blank are derived from the same Zirconia powder as the regular Zirdent 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 appears to be an FDA 510(k) Premarket Notification summary for a dental device, "Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific "acceptance criteria" through a clinical efficacy study involving human readers or AI algorithms.
Therefore, many of the requested items regarding acceptance criteria, expert ground truth, adjudication, MRMC studies, standalone AI performance, and AI training/test sets are not applicable to this document. This document describes a material equivalence study, not an AI or diagnostic efficacy study.
However, I can extract the relevant information regarding the performance testing that was conducted.
Here's an interpretation based on the provided text:
Device: Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
This device is a dental material (zirconia blanks) used for dental restorations. The "acceptance criteria" in this context refer to the physical and chemical properties of the material and its biocompatibility, as measured against international standards and comparison to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this material are defined by adherence to international standards and demonstration of equivalent performance to a predicate device.
| Acceptance Criterion (Standard/Test) | Reported Device Performance (Zirdent Dental Zirconia Blank) | Conclusion |
|---|---|---|
| Material Composition | Conforms to ISO 13356: Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) | Pass |
| - Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3) content | ≥ 99.0% | Pass (Higher than predicate ≥ 98.0%) |
| - Inorganic Pigments (for Pre-Shaded) | Fe2O3, Er2O3, and MnO 1450°C | Pass (Slightly lower than predicate > 1500°C, but performance passed) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of samples (e.g., number of zirconia blanks or specimens) used for each bench test (e.g., flexural strength, solubility). It generally states "Bench testing was performed per ISO 6872:2015 and internal procedures." For biocompatibility, it refers to standard animal models (e.g., Syrian hamsters, guinea pigs, ICR mice, rats, rabbits), implying sample sizes appropriate for those in-vivo tests according to the ISO standards.
- Data Provenance: The study was conducted by Zirdent New Material Co., Ltd. located in Changsha, Hunan, China. The biocompatibility tests were conducted by a third-party lab, but the location of the lab and the specific origin of the test animals are not explicitly stated, beyond being "per ISO standards." The data is retrospective in the sense that it was collected prior to the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable. This is a material properties and biocompatibility study, not a study involving human expert interpretation of images or data to establish ground truth for a diagnostic AI. The "ground truth" here is defined by objective physical measurements and standardized biological responses.
4. Adjudication Method for the Test Set
Not Applicable. As per point 3, this is not a study requiring adjudication of expert opinions. The results are based on objective measurements and established biological assays.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic devices (e.g., AI for image interpretation) to compare human performance with and without AI assistance. This device is a dental material, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This device is not an algorithm.
7. The Type of Ground Truth Used
- For Physical Performance: The ground truth is defined by the specifications and limits set by international standards (ISO 13356, ISO 6872) and comparison to the performance of a legally marketed predicate device (K141724 Upcera Dental Zirconia Blank).
- For Biocompatibility: The ground truth is established by standardized biological assays (in vitro and in vivo) per ISO 10993 series and ISO 7405, where "Pass" indicates that the material meets the safety criteria (e.g., no significant toxicity, irritation, sensitization, etc.) defined by these standards.
8. The Sample Size for the Training Set
Not Applicable. This device is a physical material, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As per point 8.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.