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This LED Prolux 770 is a visible curing unit designed for polymerization of light cured materials used by dental professionals.

This LED Prolux 770 is a visible curing unit designed for polymerization of light cured materials used by dental professionals.

This query cannot be answered from the provided text. The document is a 510(k) summary for a dental curing light. It discusses the device's intended use and compares it to a predicate device, concluding that it is substantially equivalent. However, it does not provide details about specific acceptance criteria, performance studies with reported metrics, sample sizes, expert qualifications, or detailed ground truth methodologies that would typically be found in a clinical study report. The document primarily focuses on regulatory approval based on equivalence rather than detailed performance study results against specific criteria.

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