(25 days)
Dental Zirconia Ceramic 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 Ceramic is pre-shaded zirconia, and it's composed of yttria-stabilized zirconia. It contains ZrO2+HfO2+Y2O3+Al2O3 and very small amount of additional inorganic pigments (Fe2O3+Er2O3+Co3O4). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth.
Dental Zirconia Ceramic has 19 models mainly according to the flexural strength (i.e. ≥600Mpa and ≥800Mpa) and the shade uniformity in the whole blank (i.e. monolayer and multilayer). Each model also has several available shade variations. And it also offers various shapes and dimensions suitable for different milling systems.
The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method.
The proposed device is a single-use device, provided non-sterile, and its performance conforms to ISO 6872:2015/AMD 1:2018 Dentistry: Ceramic Materials.
I'm sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a "Dental Zirconia Ceramic" device. This document does not contain the specific information you requested regarding acceptance criteria and a study proving device performance, particularly related to AI/software aspects.
The document discusses:
- Device Name: Dental Zirconia Ceramic
- Regulation Number: 21 CFR 872.6660 (Porcelain Powder For Clinical Use)
- Regulatory Class: Class II
- Product Code: EIH
- Intended Use: Dental restorations using CAD/CAM or manual milling machines.
- Non-clinical Test Conclusion: Physical and mechanical properties evaluated according to ISO 6872:2015/AMD 1:2018 and ISO 13356:2015. Biocompatibility testing performed.
- Technological Characteristics: Yttria-stabilized zirconia composition, inorganic pigments for color.
- Comparison to Predicate Device: Notes similarities in intended use, patient population, principle of operation, and mechanism of action. Highlights differences in the number of models offered (new models added).
- Conclusion: Substantial equivalence to the legally marketed predicate device based on comparison and analysis.
However, it does not provide:
- A table of acceptance criteria and reported device performance in a measurable format for software or AI.
- Sample size used for the test set and data provenance for a software algorithm.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study information (human readers improve with/without AI assistance).
- Standalone (algorithm-only) performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
The device described is a ceramic material for dental restorations, not an AI or software-based medical device. Therefore, the specific types of studies and criteria you're asking about (MRMC, standalone performance, training/test sets, ground truth establishment for AI) are not present in this document.
§ 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.