(45 days)
Source of illumination for curing photo-activated dental restorative materials and adhesives.
Valo™ is an activator, ultraviolet for polymerization. In other words, it is a dental curing light used for polymerization of all photo-mitiated dental materials.
The provided text is a 510(k) premarket notification for a dental curing light called Valo™. It describes the device, its indications for use, and claims substantial equivalence to a predicate device (Palmlight). However, it does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance.
The document is a declaration of substantial equivalence based on the device being similar to an already legally marketed device, not a report of a new clinical or performance study with defined acceptance criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory filing stating that the Valo™ device is an ultraviolet activator for polymerization, intended as a source of illumination for curing photo-activated dental restorative materials and adhesives, and that it is substantially equivalent to a predicate device. It does not include the detailed performance study information you are asking for.
§ 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.