(95 days)
The Zirmon Series is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crown, bridges, inlays, and onlays.
The Zirmon Series is zirconia-based ceram provided in shapes of square and circle used to manufacture cores of all ceramic crowns, and is classified into ISO6872 Type 2 Class 1. This dental porcelain for cutting process is provided by shaping and semi-sintering zirconia powder and is used to manufacture ceramic restoration with cutting process by dental MAD/MAM, computer-assisted design system, or manufacturing units, CAD/CAM system.
The provided text describes the 510(k) summary for the "Zirmon Series" dental frame material, indicating its substantial equivalence to a predicate device. However, this document does not contain information about a study that assesses a device's performance against acceptance criteria in the context of AI/ML or diagnostic accuracy, nor does it involve human readers, ground truth establishment, or multi-reader studies.
The "Performance Data (Non-Clinical)" section refers to bench testing based on international standards for materials rather than clinical performance or diagnostic accuracy. Therefore, many of the requested details cannot be extracted from this specific document.
Below is an attempt to address the points based only on the provided text, with clear indications where the information is not available.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Standard Reference) | Reported Device Performance |
|---|---|
| ISO 6872 - Package | Met preset test criteria |
| ISO 6872 - Uniformity | Met preset test criteria |
| ISO 6872 - Freedom from extraneous materials | Met preset test criteria |
| ISO 6872 - Radioactivity | Met preset test criteria |
| ISO 6872 - Chemical solubility | Met preset test criteria |
| ISO 6872 - Flexural strength | Met preset test criteria |
| ISO 6872 - Linear Thermal Expansion Coefficient | Met preset test criteria |
| ISO 13356 - Monoclinic Phase Rate | Met preset test criteria |
| ISO 13356 - Flexural strength | Met preset test criteria |
| ISO 10993-5 - Cytotoxicity | Met preset test criteria |
| ISO 10993-11 - Acute systemic toxicity | Met preset test criteria |
| ISO 10993-10 - Oral Mucosa Irritation & Sensitization | Met preset test criteria |
| Other bench testing - Appearance | "Appearance, dimension and weight spec test" - Met preset test criteria |
| Other bench testing - Dimension | "Appearance, dimension and weight spec test" - Met preset test criteria |
| Other bench testing - Weight | "Appearance, dimension and weight spec test" - Met preset test criteria |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document refers to "the following properties were tested" but does not give sample sizes for these material property tests.
- Data provenance: Not specified. The testing was non-clinical (bench testing) and likely performed by the manufacturer (KUWOTECH Co., Ltd.) in the Republic of Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not available. The testing involved material properties against international standards, not diagnostic accuracy requiring expert interpretation.
4. Adjudication method for the test set
- Not applicable and not available. The testing involved material properties, not an assessment requiring adjudication of diagnostic findings.
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 and not available. This is a non-clinical submission for a dental material, not an AI/ML or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable and not available. This is not an algorithm-based device.
7. The type of ground truth used
- The "ground truth" for the material tests was defined by the requirements and measurement methodologies specified in the cited ISO standards (e.g., specific thresholds for flexural strength, chemical solubility limits, etc.). It is not based on expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
- Not applicable and not available. This device is a material, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable and not available. (Same as 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.