(61 days)
EURO 50 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 50 can be veneered with suitable dental ceramics as well as with dentalcomposites.
EURO 50 is a gold-palladium ceramic alloy with high contents of noble metals (78,2%) intended for dental technicians to fabricate dental restorations. It 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 50 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 50 can be veneered with suitable dental ceramics and with dental composites.
This document is a 510(k) summary for a dental alloy, not a medical device that uses AI or requires performance studies with complex acceptance criteria. Therefore, most of the requested information (sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable.
However, I can extract information related to the device's characteristics and compliance with existing standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Complies with ISO 9693 | Fully complies to ISO 9693 |
| Fulfills essential requirements of European Directive 93/42/ECC concerning medical devices | Fulfills the essential requirements of the European Directive 93/42/ECC |
| High corrosion resistance | Highly corrosion resistant |
| Excellent biocompatibility | Excellent biocompatibility |
| Noble metal content | 78.2% (Gold-Palladium alloy) |
| Free of copper | Free of copper |
| Indication for single crowns, up to long span bridges with two or more pontics | Indication ranges from single crowns up to long span bridges with two or more pontics |
| Suitable for telescopic and milling work | Suitable for telescopic and milling work |
| Veneerable with suitable dental ceramics and dental composites | Can be veneered with suitable dental ceramics and with dental composites |
Note: The document does not describe specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) or a study specifically designed to "prove" the device meets these criteria in a performance study context. Instead, it states the device's inherent properties and its compliance with established industry standards and regulations for dental materials. The "study" in this context would be the internal testing and documentation leading to the certification against ISO 9693 and compliance with the EU directive.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a material submission, not an AI/performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a dental alloy, the "ground truth" would be established through material science testing (e.g., mechanical properties, corrosion resistance, biocompatibility assays) according to international standards (like ISO 9693) and regulatory requirements (EU Directive 93/42/ECC).
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
§ 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.