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GPW-SF is a high fusing white colored gold based solder for brazing porcelain-fused-to-metal alloys prior to the application and firing of the porcelain enamel. It is intended for use in the manufacture of single units, short-span and long-span bridges.

GPW-SF Solder

This is a 510(k) clearance letter for a dental solder, GPW-SF Solder, not a study evaluating a medical device's performance against acceptance criteria. Therefore, I cannot extract the requested information as it is not present in the provided text.

The document indicates that the device is "substantially equivalent" to legally marketed predicate devices for its intended use, which is a regulatory decision rather than a performance study. It states:

• Device Name: GPW-SF Solder
• Intended Use: "GPW-SF is a high fusing white colored gold based solder for brazing porcelain-fused-to-metal alloys prior to the application and firing of the porcelain enamel. It is intended for use in the manufacture of single units, short-span and long-span bridges."

The letter does not contain:

• A table of acceptance criteria or reported device performance.
• Information on sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details.
• Any description of a study conducted to demonstrate the device meets specific performance criteria.

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