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Astralis 10 is a hand held polymerization unit used to cure dental composites

Astralis 10 is a hand held polymerization unit

The provided text is a 510(k) premarket notification decision letter from the FDA for a device named "Astralis 10," an Ultraviolet Activator for Polymerization used to cure dental composites.

This document, like many 510(k) letters, focuses on the determination of "substantial equivalence" to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study report as would be found in a clinical trial publication or a detailed engineering specification document.

Therefore, the specific information requested in the prompt regarding acceptance criteria, study design elements (sample size, data provenance, expert involvement, adjudication, MRMC, standalone performance, ground truth establishment, training set size) is not present in the provided text.

The core of this FDA letter is to state that the Astralis 10 is substantially equivalent to a predicate device and can therefore be marketed. It does not contain the detailed performance metrics or study methodology you've asked for.

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