(50 days)
Portadur P 4 is a gold 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, Removable partials and can be used for Telescopic and milling work.
Portadur P 4 is an extra-hard gold casting alloy with high contents of noble metals (75.5%), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and to removable partials. In addition, it is suitable for telescopic and milling work. Portadur P 4 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
The provided text is a 510(k) summary for a dental alloy, Portadur P 4. It describes the device, its intended use, and states that it complies with international standards for such materials. However, it does not contain information about a study with acceptance criteria to demonstrate device performance beyond compliance with ISO 1562.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication, MRMC study, standalone performance), or ground truth establishment based on the provided text.
The text affirms that "Portadur P 4 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." This statement implies that compliance with ISO 1562 and European directive 93/42/ECC are the primary "acceptance criteria" for demonstrating the device's properties. However, specific performance metrics against these standards are not detailed.
§ 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.