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Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses:

precious metal inlays, onlays, and crowns;

precious metal bridges, bars, and attachments;

precious metal copings and bridges for porcelain-fusedto-metal restorations.

Orion Vesta is recommended for use with any normal-fusingtemperature porcelain product in porcelain-fused-to-metal restorations of from one crown up to a full-span bridge.

After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.

Orion Vesta Dental Alloy

This document is an FDA 510(k) clearance letter for the Orion Vesta Dental Alloy. It does not contain the kind of detailed information about acceptance criteria, study design, or performance metrics that would be provided in a clinical study report or a more technical submission.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Here's why and what kind of document would contain this information:

• 510(k) Clearance Letter: This letter confirms that a device is substantially equivalent to a legally marketed predicate device. It doesn't typically delve into the specifics of performance testing beyond stating that the device meets its intended use.
• Acceptance Criteria & Performance: This information would be found in the "Performance Data" or "Non-Clinical Testing" sections of the 510(k) submission itself (which is not provided here), or in a specific study report for the device.
• Study Details (Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone): These are all elements of a detailed study design and results, which would be in a clinical or non-clinical study report and not summarized in the clearance letter.
• Training Set Information: This is relevant for AI/ML-based devices, which the Orion Vesta Dental Alloy (a physical dental material) is not.

To answer your request, I would need a document that describes the actual testing and validation performed on the Orion Vesta Dental Alloy, rather than just the FDA's clearance letter.

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