(146 days)
"Hyramic CAD/CAM Restorative" is used for dental restorations, such as full crowns, inlays/onlays and veneers.
"Hyramic CAD/CAM Restorative" consists of inorganic filler and polymer material to form a homogeneous solid block material. The inorganic filler is derived from glass powders, while the resin is derived from methacrylate co-polymer (UDMA,TEGDMA、 and BisGMA). The formed blocks have a microstructure of inorganic materials embedded in a highly cured resin matrix. The unique combination of the two materials creates a uniform hybrid, which lends the positive physical properties of each individual material to the other. The material has been processed through various molding techniques – into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of dental restorations such as full crowns, inlays/onlays and veneers. "Hyramic CAD/CAM Restorative" is hybrid ceramic/resin dental blanks designed for the manufacture of dental prosthetic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic dental devices are intended for single use applications. At the dental lab, the blanks are held to the CAD/CAM machine which is used to machine to the final dental restoration. Unlike conventional ceramic restorations, customization and glaze firing is not necessary for Hyramic CAD/CAM Restorative. "Hyramic CAD/CAM Restorative" is supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of twenty one different colors, two different translucencies, and two different aesthetic effects (single and multilayer).
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria, structured according to your requested information.
It's important to note that this document is a 510(k) Summary. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical efficacy studies akin to what might be required for a novel device or a PMA. Therefore, the information might not align perfectly with what one would expect for a complex AI/software medical device.
Key takeaway: This document describes a traditional dental material (Tooth Shade Resin Material) and not an AI or software device. As such, many of the questions related to AI-specific elements (like MRMC studies, AI improvement, standalone algorithm performance, training set details) are not applicable. The "device" here is a physical material for dental restorations.
1. A table of acceptance criteria and the reported device performance
Based on the document, the acceptance criteria are primarily derived from the ISO 10477 standard for "Dentistry - Polymer-based crown and bridge material." Specific numerical acceptance criteria are not explicitly listed in this summary, but the general statement is that "All tests were verified to meet acceptance criteria." and "results met all relevant requirements in the test standard."
| Feature/Test | Acceptance Criteria | Reported Device Performance (Hyramic CAD/CAM Restorative) |
|---|---|---|
| Mechanical Properties | ||
| Flexural Strength | Per ISO 10477 | "very similar to the predicate device" (and predicate met ISO 10477 requirements) |
| Water Absorption | Per ISO 10477 | "very similar to the predicate device" (and predicate met ISO 10477 requirements) |
| Solubility in Water | Per ISO 10477 | "very similar to the predicate device" (and predicate met ISO 10477 requirements) |
| Biocompatibility | ||
| Biocompatibility tests | Per ISO 10993 | "met all relevant requirements in the test standards, and are comparable to the predicate device." |
2. Sample sized used for the test set and the data provenance
The document does not specify the sample sizes used for the mechanical or biocompatibility tests. It also does not explicitly state the provenance of the data in terms of country of origin or whether it was retrospective or prospective, beyond stating that testing was performed. These are bench tests on material samples, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a physical dental material, and the "ground truth" for its performance is established through standardized laboratory testing (e.g., measuring flexural strength, water absorption), not by expert interpretation of data.
4. Adjudication method for the test set
This question is not applicable, as there's no expert interpretation or consensus involved in establishing the "ground truth" for material properties.
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
This question is not applicable. The device is a physical dental restoration material, not an AI or software algorithm that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is not an algorithm.
7. The type of ground truth used
The ground truth for the performance of the "Hyramic CAD/CAM Restorative" is established through standardized laboratory measurements and physical property testing as defined by ISO 10477 and ISO 10993. This is akin to "benchmark" data for material science, not clinical pathology or outcomes data.
8. The sample size for the training set
This question is not applicable. There is no concept of a "training set" for a physical dental material like this. The material is manufactured, and its properties are then tested.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this type of device.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.