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Auropal Solder W-2 is intended for use as a secondary solder in operations in which dental alloy(s) parts are joined to form a dental restoration. lt should be used only together with recommended dental alloys with suitable melting ranges and compositions.

Auropal Solder W-2 is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a yellow alloy with high contents of precious metals (Gold and Silver: 84%). Auropal Solder W-2 is suitable for use as a filler material in operations in which dental alloy(s) parts are joined to form a dental restoration, e.g. bridges. It is intended as a secondary solder for dental alloys with appropriate melting ranges and compositions, especially ECO E4, which is manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. As primary solder Auropal Solder M-1 should be used. Auropal Solder W-2 is highly corrosion resistant. It fully complies to the international standard ISO 9333 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.

The provided text describes a 510(k) premarket notification for a dental solder, Auropal Solder W-2. It establishes substantial equivalence by comparing it to a legally marketed predicate device (Argesol 750Y).

However, the document does not contain information about acceptance criteria, device performance from a study, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. The document primarily focuses on regulatory approval based on demonstrating compliance with standards and equivalence to a predicate device.

The only "performance" claim is that the device "fully complies to the international standard ISO 9333 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices," and that it is "highly corrosion resistant."

Therefore, I cannot populate the table or answer the questions as requested because the necessary information about a specific study and its criteria/results is not present in the provided text.

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