Search Results

The NuVasive MaXcess Light Guide is intended to provide surgical site illumination from a high intensity light source.

The NuVasive MaXcess Light Guide is a fiberoptic surgical light designed to be compatible with a variety of high intensity light sources.

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary and an FDA clearance letter for the NuVasive MaXcess Light Guide.

This type of document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting detailed performance study data against specific quantitative acceptance criteria. The text mentions that "Engineering drawings, and labeling have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device." However, it does not provide the specifics of any performance study, test sets, ground truth establishment, or statistical analyses typically associated with proving a device meets acceptance criteria.

Ask a specific question about this device