(61 days)
EURO 45 is a gold-palladium ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Crowns, Short span bridges, Long span bridges and can be used for Telescopic and milling work. EURO 45 can be veneered with suitable dental ceramics as well as with dentalcomposites.
EURO 45 is a gold-palladium ceramic alloy with high contents of noble metals (79,5%) intended for dental technicians to fabricate dental restorations. lt has an indication which ranges from single crowns up to long span bridges with two or more pontics. It is free of copper and therefore suitable for telescopic and milling work. EURO 45 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. EURO 45 can be veneered with suitable dental ceramics and with dental composites.
This 510(k) premarket notification is for a dental alloy, not an AI/ML-enabled medical device. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, standalone performance, ground truth establishment methods, or training set details) are not applicable to this document. The document describes a traditional medical device (dental alloy) and its compliance with established standards for materials.
However, I can extract the relevant information regarding the acceptance criteria and how the device meets them based on the provided text.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| High contents of noble metals | 79.5% noble metals |
| Corrosion resistant | Highly corrosion resistant |
| Biocompatibility | Excellent biocompatibility |
| Compliance with ISO 9693 | Fully complies with ISO 9693 |
| Compliance with European directive 93/42/ECC | Fulfills the essential requirements of 93/42/ECC |
| Suitable for veneering with dental ceramics | Can be veneered with suitable dental ceramics |
| Suitable for veneering with dental composites | Can be veneered with suitable dental composites |
| Free of copper | Free of copper (suitable for telescopic and milling work) |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified in the provided document. The basis of testing is typically material property evaluation rather than a "test set" in the context of data-driven models.
- Data provenance: Not explicitly stated as "country of origin" for data. The testing is implied to be conducted by the manufacturer, Wieland Edelmetalle GmbH & Co. (Germany), to meet international standards. This would typically involve laboratory testing of material batches.
- Retrospective/Prospective: Not applicable in the context of material property testing for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a dental alloy's material properties (e.g., corrosion resistance, noble metal content, biocompatibility) is established through standardized laboratory testing and analytical chemistry, not expert consensus in the way an AI model's output would be adjudicated.
4. Adjudication method for the test set
Not applicable. Material properties are measured against objective standards, not adjudicated by experts in a concensus method.
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. This is for a dental alloy, not an AI/ML-enabled medical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a dental alloy, not an AI/ML-enabled medical device.
7. The type of ground truth used
The ground truth used for this device would be:
- Physical and chemical measurements against International Standards (specifically ISO 9693 for dental casting alloys).
- Compliance with European Directive 93/42/ECC through demonstration of essential requirements met.
- Laboratory testing results (e.g., noble metal content by analytical methods, corrosion testing, biocompatibility assays).
8. The sample size for the training set
Not applicable. This is for a dental alloy, not an AI/ML-enabled medical device.
9. How the ground truth for the training set was established
Not applicable. This is for a dental alloy, not an AI/ML-enabled medical device.
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.