(46 days)
The Demetron LC is a visible curing unit intended for polymerization of light cure materials and activation of dental bleaching materials.
The Demetron LC curing light is a device used for the polymerization of dental materials. It consists of a gun and a base stand connected by a cord. The base stand will contain an on/off switch, a gun hanger, and a beeper that generates an audible tone at ten second intervals. The gun trigger will turn the light on until the trigger is actuated again to turn off. The fan will run continuously whenever the unit is on.
This looks like a 510(k) premarket notification for a dental curing light, which is a device for polymerization of dental materials, not an AI/ML powered device. As such, the concepts of "acceptance criteria," "study," "ground truth," "training set," and "test set" as they relate to AI/ML device performance are not applicable in this context.
The document describes the device, its intended use, and claims substantial equivalence to another legally marketed device (Kerr Corporation, Optilux 400). The FDA's review confirms this substantial equivalence.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth, as these are evaluation metrics for AI/ML performance and are not found in this type of submission for a non-AI/ML medical device.
§ 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.