Search Results

For the polymerization of light-curing dental materials curing in the wavelength range of 380-515 nm.

Not Found

This document is an FDA 510(k) clearance letter for the bluephase® 20i, an ultraviolet activator for polymerization, and does not contain the detailed information required to fill out the table and answer the questions about acceptance criteria and a study proving device performance.

The FDA letter confirms that the device is substantially equivalent to a legally marketed predicate device, but it does not provide:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test or training sets.
• Information on data provenance.
• The number or qualifications of experts for ground truth.
• Adjudication methods.
• Whether MRMC or standalone studies were performed, or their results.
• The type of ground truth used.
• How ground truth for training data was established.

This kind of detailed performance data and study methodology is typically found in the 510(k) submission itself or in a separate clinical or performance study report, which is not part of this FDA clearance letter.

Ask a specific question about this device