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Auropal 50 is a gold-silver 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. Auropal 50 can be veneered with dental-composites.

Auropal 50 is a dental gold-silver casting alloy (55% noble metals), intended for dental technicians to fabricate dental restorations. On the basis of it's mechanical properties, Auropal 50 is a Type 4 casting alloy, according to ISO 8891. The indications of Auropal 50 comprise inlays/onlays, crowns and short span bridges. Auropal 50 is highly corrosion resistant and it fully complies with the requirement of the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.

The provided text is a 510(k) Premarket Notification for the medical device Auropal 50, a dental gold-silver casting alloy. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (G-Cast Degussa AG) rather than presenting a study to prove performance against specific acceptance criteria using a test set.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The 510(k) summary states:

• Device Description: Auropal 50 is a dental gold-silver casting alloy (55% noble metals), intended for dental technicians to fabricate dental restorations.
• Classification: Type 4 casting alloy, according to ISO 8891, based on its mechanical properties.
• Indications for Use: Inlays/onlays, crowns, and short span bridges. It can be veneered with dental composites.
• Compliance: "Auropal 50 is highly corrosion resistant and it fully complies with the requirement of the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices."

The FDA's letter (K021733) confirms the substantial equivalence determination based on the information provided by the manufacturer. This process typically relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate device, often through a comparison of material properties and adherence to established standards (like ISO 8891 mentioned here) rather than new clinical trials or performance studies with ground truth.

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