(94 days)
The intended use of Power LED is to act as a polymerization source using visible light to cure composite resins.
The Power LED Cordless Curing Light is a device used for the polymerization of dental materials using visible light. It consists of a cordless LED curing handpiece, a battery charger and a remote handpiece holder. The plastic molded handpiece will contain a detachable rechargeable battery pack, an LED light "engine". A printed circuit board with a digital circuit will be utilized to control four different curing modes. Each mode specifies LED timing and audible beep timing. A segmented display will depict the curing modes. A separate pushbutton will activate the light. The molded plastic battery charger will have a single well for charging the battery pack, and Indictor lights to indicate battery charge status.
This K033697 submission for the "Power LED" curing light device does not contain information about specific acceptance criteria or a study proving the device meets those criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria.
Here's why the requested information cannot be extracted from the provided text:
- No acceptance criteria: The document does not list any quantitative or qualitative metrics that the device needs to achieve to be considered "acceptable."
- No performance study details: There is no mention of a study design, methodology, results, or data used to demonstrate specific performance levels. The "Substantial Equivalence" section states that the device "functions in a manner similar to and is intended for the same use as the Elipar Freelight designed by ESPE AG," implying that its performance is expected to be similar, but no comparative data is provided.
Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details because this information is not present in the provided 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.