(111 days)
Staining and/or characterization and glazing of ceramic materials from Ivoclar Vivadent and Wieland Dental:
- Veneering ceramics
- Press ceramics
- Milling ceramics
- Zirconium oxide (framework and full-contour)
IPS Ivocolor is a universal stains and glaze assortment consisting of 23 shades of Essence porcelain, 9 shades of Dentin porcelain, 3 incisal porcelains, 2 Glaze powders, 2 glaze pasts, 2 Mixing Liquids, Essence fluid and shade guides. The range of products has been coordinated with the layering, press and CAD Ceramics from Ivoclar Vivadent and the zirconium oxides from Wieland Dental and be used regardless of the CTE of the ceramic. The difference is that IPS Ivocolor can be used with both metal-ceramic and fullceramic materials.
This document is a 510(k) summary for a dental product called IPS Ivocolor. It details the product's description, indications for use, comparison to predicate devices, and a conclusion of substantial equivalence. However, it does not describe a study that proves the device meets acceptance criteria in the way that an AI/ML device submission would.
The document discusses the physical properties and compatibility of the dental material itself, rather than the performance of a diagnostic algorithm. Therefore, the requested information categories (sample size, experts, adjudication, MRMC, standalone, etc.) are structured for AI/ML device studies and are not applicable to this type of traditional medical device submission.
I can extract the acceptance criteria (in terms of physical properties) and the reported device performance related to those criteria from the document, but it will not be presented in the context of an AI/ML study.
Here's the information that can be extracted, interpreted within the context of a traditional device submission (not AI/ML):
Acceptance Criteria and Reported Device Performance (as related to physical properties of dental materials)
| Acceptance Criteria (from ISO 6872) | Reported Device Performance (IPS Ivocolor) |
|---|---|
| Uniformity | Meets requirements |
| Cleanliness | Meets requirements |
| Radioactivity of ceramic | Meets requirements |
| Color Coding | Meets requirements |
| Flexural Strength | Meets requirements |
| Coefficient of Linear Thermal Expansion (CTE) | Slightly lower than primary predicate, ensures compatibility with chosen ceramics |
| Glass Transition Temperature | Slightly lower than primary predicate, ensures compatibility with chosen ceramics |
| Chemical Solubility | Meets requirements |
Study Details (Note: These categories are for AI/ML studies and are not directly applicable to this traditional dental material submission. The information below is an interpretation based on the document's content, if an analogy were to be forced.)
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Sample size used for the test set and the data provenance: Not applicable. This device is a dental material, and the "test set" would be the physical samples tested according to ISO 6872. The document does not specify the number of samples. The provenance of the "data" (i.e., test results) would be from in-house laboratory testing by the manufacturer.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For dental material properties, "ground truth" is established by standardized laboratory testing methods (e.g., ISO 6872), not by expert consensus on diagnostic images.
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Adjudication method for the test set: Not applicable. Standardized lab tests have pass/fail criteria based on ISO standards.
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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 is not an AI/ML diagnostic device nor a reader study.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a dental material, not an algorithm.
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The type of ground truth used: Standardized physical property measurements according to ISO 6872.
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The sample size for the training set: Not applicable. There is no training set for a material like this. Development would involve experimental formulation and testing.
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How the ground truth for the training set was established: Not applicable.
Summary of the Document's "Study" Information (in its actual context):
The document describes material testing to demonstrate that IPS Ivocolor meets the requirements of ISO 6872 for ceramic materials. This is a standard for dental ceramic materials and specifies various physical properties and their acceptable ranges. The manufacturer performed tests on IPS Ivocolor for properties such as uniformity, cleanliness, radioactivity, color coding, flexural strength, coefficient of linear thermal expansion (CTE), glass transition temperature, and chemical solubility. The document states that the product "meets the requirements" for these tests. It also notes that the CTE and Glass transition temperature are "slightly lower than those of the primary predicate," which is presented as a design choice to ensure compatibility with a wider range of ceramics.
The primary "proof" of meeting acceptance criteria for this type of device is compliance with relevant international standards for dental materials (like ISO 6872) and demonstrating substantial equivalence to a legally marketed predicate device through comparative data (chemical composition, physical properties, indications for use, and operating principles).
§ 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.