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Non-Precious Dental Casting Alloy . Suitable for use in fabrication of removable dental appliances.

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The provided document is an FDA 510(k) clearance letter for a dental casting alloy, not a study evaluating an AI-enabled medical device. Therefore, it does not contain information related to acceptance criteria, study methodologies, or AI performance metrics as requested in the prompt.

Specifically, the document establishes the substantial equivalence of the "PD Casta-H" device to legally marketed predicate devices, allowing it to be marketed. This process does not involve the type of performance evaluation, ground truth establishment, or statistical analysis typically associated with AI device studies.

Therefore, I cannot provide the requested information based on the given document.

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Non-Precious Dental Casting Alloy. Suitable for use in the fabrication of Ceramic Fused to Metal (metallo-ceramic) dental restorations.

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The provided text describes a 510(k) premarket notification for a dental alloy, Ceracast-V. It does not contain information about acceptance criteria, device performance details, or any study involving AI assistance for medical image analysis. Therefore, I cannot generate the requested information based on the provided input.

The document is a clearance letter from the FDA, stating that Ceracast-V is substantially equivalent to legally marketed predicate devices for use as a non-precious dental casting alloy in ceramic fused to metal dental restorations. It does not involve any algorithm performance or clinical study data as typically seen with AI/ML-enabled medical devices.

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