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Brite Gold XH alloy intended to be used for onlays, % crowns, crowns and short span bridges PFM crowns

Bright Gold

I am sorry, but based on the provided text, I cannot provide a description of the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a dental alloy named "Bright Gold xh" (and later corrected to "Brite Gold XH").

The letter states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device has been found to be as safe and effective as a device already on the market, but it does not include details about specific performance acceptance criteria or a study demonstrating that the device meets those criteria.

The document primarily focuses on:

• The device name and regulation details.
• The FDA's finding of substantial equivalence.
• Regulatory requirements and responsibilities for the manufacturer.
• The intended indications for use (onlays, ¾ crowns, crowns, short span bridges, PFM crowns).

It does not contain the specific information requested in your prompt regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance of a test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for the training set was established.

These kinds of details would typically be found in the premarket notification submission itself (which is not provided here) or in a separate study report, not in the FDA's clearance letter.

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Bright Gold alloy intended to be used for inlays ,single crown and 3 unit anterior bridges.

Not Found

This document is a 510(k) clearance letter from the FDA for a dental alloy named "Bright Gold." It does not describe the acceptance criteria or a study that proves the device meets those criteria from an AI/algorithm perspective.

Instead, this document is related to a conventional medical device (a dental alloy) and its clearance is based on substantial equivalence to a legally marketed predicate device, rather than performance against pre-defined acceptance criteria for an AI model.

Therefore, I cannot extract the requested information from this document. The questions you've asked are specific to AI/Machine Learning device studies and their performance validation, which is not covered in this FDA clearance letter for a physical material.

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