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This is a yellow casting alloy for inlay / onlays, crowns, short span bridges, long span bridges, removable partials.

LUCIUS 76 is a platinum-free crown and bridge alloy. This device is dependable 76% gold alloy with a high gold appearance. LUCIUS 76 is an excellent for inlays, three-quarter crowns, long and short-span bridges.

The provided document is a 510(k) summary for a dental casting alloy, not an AI/ML medical device. Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device are not applicable or cannot be extracted from this particular document.

However, I can provide the information that is present in the document related to the device's characteristics and its comparison to a predicate device, which serves as its "acceptance criteria" and "study" for substantial equivalence.

1. A table of acceptance criteria and the reported device performance

For a traditional medical device like a dental alloy, "acceptance criteria" for 510(k) clearance are primarily about demonstrating substantial equivalence to a legally marketed predicate device. This is typically done by comparing characteristics like composition and physical/mechanical properties. The "reported device performance" is the measured values for the new device and the predicate.

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