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The Microlux Transilluminator is a device used upon initial examination of the dental patient to help locate crown fractures, posterior and anterior caries.

The Microlux Transilluminator is a screening device used to help locate caries and crown fractures. It also functions as an auxiliary light source to aid in operative procedures and preventive dentistry.

The Microlux Transilluminator consists of a battery powered, high output L.E.D. light source, (three 'N" size batteries are included) and a fiber-optic glass light guide with either a 3mm or 2mm tip. The fiber-optic glass light guide snaps into the light source. The fiber-optic light guide is autoclaveable. The light source can be wiped with disinfectant. Disposable custom fitted sleeves are also available the cover the entire unit to prevent cross contamination.

The provided text is a 510(k) summary for the Microlux Transilluminator, a device used to aid in visualizing caries and crown fractures. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) summary focuses on establishing substantial equivalence to legally marketed predicate devices, primarily highlighting the difference in light source technology (LED vs. halogen/incandescent lamps). It does not describe any performance studies or clinical trials with acceptance criteria, sample sizes, ground truth establishment, or expert evaluations.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the given input.

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