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Precious alloy for use in Crown and Bridge dental restorations.

Sterngold 66 is a White Crown and Bridge Alloy.

This is a traditional 510(k) submission for a dental alloy, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device is not available in the provided documents.

The submission focuses on demonstrating substantial equivalence to predicate dental alloys based on material properties and intended use. The "Safety and Performance" section states:

"This submission is a Special 510(k): Abbreviated 510(k) as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.' In support of this 510(k), Sterngold has provided information to demonstrate conformity with FDA's guidance document entitled Guidance Document for the Preparation of Premarket Notifications [510(k) s] for Dental Alloys)."

This indicates that the "acceptance criteria" for a dental alloy would relate to its physical, chemical, and biological properties (e.g., biocompatibility, corrosion resistance, mechanical strength) as defined in relevant consensus standards or FDA guidance documents for dental alloys, rather than performance metrics for an AI/ML algorithm. The "study" would involve material testing to show these properties meet established benchmarks or are comparable to predicate devices.

Since the provided information is for a physical medical device (dental alloy), AI/ML-specific questions like sample size for test/training sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable.

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