(91 days)
IRIS - High Strength Glass Ceramic is a system of precrystallized and/or fully crystallized zirconia reinforced lithium silicate glass ceramics and veneering ceramics processed through CAD-CAM techniques for the fabrication of: Single unit dental restorations, for example all-ceramic crowns, inlays, onlays and veneers. IRIS can be used as a substructure which is then veneered with IRIS veneering ceramic or can be used for full-contour application (without veneering) as well.
IRIS - High Strength Glass Ceramic is a system of glass ceramic dental materials based on zirconia reinforced lithium silicate chemistries and feldspathic veneering ceramics and accessories optimized to be compatible with IRIS glass ceramics. The system consists of: A. IRIS Flex: High Strength Glass Ceramic (HSGC) CAD CAM blanks provided in the fully crystallized state, for machining and subsequent placement. B. IRIS CAD: High Strength Glass Ceramic (HSGC) CAD CAM blanks provided in the partially crystallized state, for machining, crystallization firing, and subsequent placement. C. Veneering ceramics provided in powder/paste forms and are intended for optional esthetic characterization of the CAD CAM restorations. IRIS materials may be veneered with a compatible dental veneering ceramic or can be used as anatomically shaped full-contour restorations without veneering.
The provided text describes the "IRIS - High Strength Glass Ceramic" device and its substantial equivalence to a predicate device, rather than a clinical study evaluating its performance against specific acceptance criteria. Therefore, several requested sections of the response, such as sample sizes, expert qualifications, and adjudication methods, cannot be directly extracted as they relate to clinical effectiveness studies, which were explicitly stated as "Not applicable. No human clinical testing was conducted to support the substantial equivalence of the IRIS - High Strength Glass Ceramic."
However, the document does detail material properties testing, which serves as the "study" proving the device meets material-related acceptance criteria.
Here's the information that can be extracted and a clear indication of what is not applicable based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for the IRIS - High Strength Glass Ceramic are primarily based on ISO 6872 standards and comparability to the predicate device, IPS e.max CAD (K051705). The reported performance indicates the device meets these criteria.
| Acceptance Criteria Category | Specific Criteria (Implicitly ISO 6872) | Reported Device Performance | Study Proving Acceptance |
|---|---|---|---|
| Mechanical Properties | Flexural strength meets ISO 6872. | IRIS Flex materials can be raised to >300 MPa through an optional glaze firing process. Measurements showed comparable mechanical (flexural strength) to predicate and met ISO 6872. | Physical Properties Testing (Non-Clinical) |
| Chemical Stability | Solubility meets ISO 6872. | Measurements showed comparable chemical stability (solubility) to predicate and met ISO 6872. | Physical Properties Testing (Non-Clinical) |
| Biocompatibility | Meets ISO 10993-1:2009. | Characterized for cytotoxicity, intracutaneous reactivity/irritation, systemic toxicity, and genotoxicity. Results support biocompatibility. | Toxicological Testing (ISO 10993-1:2009) |
| Long-term Stability | Comparable to predicate device. | Verified by simulated life testing (thermal cycling, mechanical loading). | Physical Properties Testing (Non-Clinical) |
2. Sample size used for the test set and the data provenance
Not Applicable for clinical performance. The document explicitly states: "No human clinical testing was conducted to support the substantial equivalence of the IRIS - High Strength Glass Ceramic." The "test set" for the non-clinical material property evaluations would refer to laboratory samples, but specific sample sizes are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. No human clinical testing was performed, so there was no need for experts to establish ground truth in a clinical context. The "ground truth" for material properties is established by adherence to recognized international standards (e.g., ISO 6872, ISO 10993-1).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. Adjudication methods are relevant for human interpretation in clinical studies, which were not conducted. Validation for non-clinical testing relies on standard laboratory protocols and accredited testing facilities.
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. No human clinical testing or multi-reader studies were conducted. This device is a dental material, not an AI diagnostic tool.
6. 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, so the concept of standalone algorithmic performance is irrelevant. The performance is assessed based on physical and chemical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical studies:
- Mechanical and Chemical Properties: The ground truth is defined by international standards (ISO 6872) for dental ceramics. Comparability to a legally marketed predicate device (IPS e.max CAD) also serves as a ground truth baseline.
- Biocompatibility: The ground truth is established by the accepted methods and criteria within international standard ISO 10993-1:2009 (Biological evaluation of medical devices – Part 1: Evaluation and Testing).
8. The sample size for the training set
Not Applicable. No "training set" in the context of machine learning or clinical trials was involved. If referring to laboratory samples used for initial development and optimization, that information is not provided.
9. How the ground truth for the training set was established
Not Applicable. As no "training set" for an algorithm or clinical trial was used, this question is not applicable. The development of the material would follow established scientific and engineering principles for material science, with properties characterized against known material benchmarks.
§ 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.