(54 days)
Eco E4 is a silver-palladium casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Inlays/onlays - Crowns - Short span bridges - Long span bridges Eco E4 can be veneered with suitable dental composites.
Eco E4 is a high strength silver-palladium casting alloy, intended for dental technicians to fabricate dental restorations. It consists of silver, palladium and gold (93,5%) as well as of copper and zinc. Eco E4 has an indication for use which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics. It complies with the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
The provided document is a 510(k) premarket notification for a dental alloy, Eco E4. It outlines the device description, its intended use, and its equivalence to a predicate device. The document does not contain any information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy studies.
Instead, it focuses on the materials science and regulatory compliance aspects of a physical product (dental alloy). Therefore, I cannot extract the requested information based on the input document.
The document indicates that Eco E4 is a "high strength silver-palladium casting alloy" for dental restorations and that it "complies with the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." This implies that the 'acceptance criteria' for this device would relate to its material properties and manufacturing standards, not to diagnostic accuracy.
No information is available in the provided text regarding:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI/ML.
- Sample size used for a test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.