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Gold Core 35 is a noble, yellow alloy to be used for inlays, onlays, single crown, bridges,. implant superstructures and substrate for low fusing, high expansion porcelains and composites. .

Gold Core 35 is a noble, yellow alloy to be used for inlays, onlays, single crowns, bridges, implant superstructures and substrates for low fusing, high expansion porcelains and composites. Gold Core 35 is substantially equivalent to Gold Core 55, K993173 with the exception of a minor few elements. However, the addition of these elements does not affect safety and effectiveness.

This is a 510(k) summary for "Gold Core 35", a noble, yellow alloy used for dental restorations. The provided document does not contain information about acceptance criteria, device performance, a study, or any of the other specific details requested in your prompt (sample size, experts, adjudication, MRMC study, standalone performance, ground truth, training set).

The document is a regulatory approval letter from the FDA, stating that Gold Core 35 is substantially equivalent to a previously marketed predicate device (Gold Core 55, K993173). It focuses on regulatory compliance rather than presenting scientific or clinical study data.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria using the provided text. The requested information simply isn't present.

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