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Used for brazing dental alloys prior to porcelain application.

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The provided document is an FDA 510(k) clearance letter for a dental solder, DW 296 #15 Solder. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the context of an AI/algorithm-driven device.

The document is a regulatory approval, confirming that the device is substantially equivalent to a legally marketed predicate device for its intended use (brazing dental alloys prior to porcelain application). It focuses on the regulatory classification and general controls, rather than performance studies with acceptance criteria as typically seen for AI/ML medical devices.

Therefore, I cannot provide the requested information from this document. If this device were an AI-driven one, the 510(k) summary (which is a separate document often submitted with the clearance) would be a more likely place to find such details.

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