Search Results

Low fusing ceramic crowns, small bridges, inlays, onlays

Not Found

The provided text is a 510(k) clearance letter from the FDA for a dental alloy named "Aurofluid Plus". It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or MRMC/standalone studies traditionally associated with AI/ML medical devices.

The information requested in your prompt (e.g., acceptance criteria, study details, expert consensus, training sets) is typically found in a device's 510(k) summary, clinical study reports, or performance testing documentation, not in the FDA clearance letter itself.

Therefore, I cannot fulfill your request with the input provided. The document is a regulatory approval, not a technical performance report.

Ask a specific question about this device