(84 days)
KaVo PolyLUX II is a handpiece for polymerization and is intended exclusively for dental treatment in regular dentistry.
PolyLUX II is a hand piece with a halogen quartz light source intended for curing dental resins.
The provided document K013500 is a 510(k) summary for a dental curing light, PolyLUX II. The summary explicitly states: "Performance Data: None required. The claim of substantial equivalence is based on comparisons of formulations and intended uses of the claimed predicate."
Therefore, based on the provided text, there is no study conducted to prove the device meets specific acceptance criteria in terms of performance. The regulatory approval was based on demonstrating substantial equivalence to predicate devices, not on a new performance study.
Given this, I cannot extract the information required in the prompt (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types and establishment methods for training and test sets) because such performance data and studies were explicitly not required and thus not provided in this 510(k) summary.
§ 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.