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This product is a light curing activator, intended to polymerize resinous dental pit and fissure sealants or restorative materials by transmission of a light through a rod.

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This document is a 510(k) clearance letter from the FDA for the "G-Light" device. It does not contain any information about acceptance criteria, study design, or performance metrics for the device.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on its substantial equivalence to existing predicate devices, not on the basis of a new clinical study demonstrating specific performance against acceptance criteria. The FDA determined that the G-Light performs as intended for its specified "Indications for Use" (a light curing activator for dental resins) because it is similar enough to devices already on the market.

Therefore, I cannot provide the requested information from this document. The sections you asked for, such as sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment, are not typically part of a 510(k) clearance document focused on substantial equivalence.

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