(252 days)
The Celalux 3 curing light is indicated for polymerization of dental materials which cure with blue light (450 nm to 480 nm).
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The provided document is an FDA 510(k) clearance letter for the Celalux 3, a dental curing light. It confirms that the device is substantially equivalent to a predicate device for its indicated use (polymerization of dental materials with blue light).
However, this document does not contain any information regarding the acceptance criteria, device performance study, sample sizes, expert qualifications, ground truth establishment, or any other details related to the evaluation of an AI/ML medical device. It is a regulatory clearance for a physical medical device (a light curing unit), not an AI algorithm.
Therefore, I cannot fulfill your request using the provided input, as the information you are asking for (related to AI acceptance criteria and study details) is not present in this document.
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.