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Construction of MOD inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain fused to metal technique.

ORION GX ALLOY is a yellow. high noble, gold-based dental alloy.

This document describes regulatory correspondence for the ORION GX ALLOY and does not contain information about acceptance criteria or a study proving device performance against such criteria. The document states that the device is "substantially equivalent" to legally marketed predicate devices based on its formulation and historical use in Europe, along with biocompatibility test results. However, it does not provide specific acceptance criteria or details of a study designed to demonstrate performance against those criteria in a structured manner as requested in the prompt.

Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The closest relevant information is:

• Predicate Devices: Degudent H Alloy K821446
• Technological Characteristics: "All of the components found in ORION GX ALLOY have been used in legally marketed devices. ORION GX ALLOY is very similar in formulation to legally marketed dental alloys. This alloy has been on the European market since 1978 with over 1.5 million units placed."
• Biocompatibility Testing: "ORION GX ALLOY was tested for Cytotoxicity and AMES mutagenicity and found to be non-cytotoxic and non-mutagenic."

These points serve as the basis for the FDA's substantial equivalence determination, but they are not presented as acceptance criteria with corresponding performance data from a specific study as outlined in the prompt's request.

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