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The device is intended to allow blind, non-directed, protected specimen brush sampling of the lower respiratory tract secretions or to perform surveillance cultures or to diagnose pneumonia in patients receiving mechanical ventilation.

The subject device is sterile and consists of a flexible polymeric inner sheath which is contained within an outer sheath. Within the inner sheath is a twisted wire brush. The outer sheath is occluded with a polyethylene glycol wax plug. Upon use, the inner sheath is advanced, the plug expelled and the brush advanced to provide a sterile, non-contaminated specimen brush.

The provided text is a 510(k) summary for a medical device submitted in 1996. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information in a table or answer the specific questions about device performance studies, sample sizes, ground truth establishment, or expert involvement.

The 510(k) summary typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results with specific acceptance criteria that would be found in a modern clinical validation study. In 1996, the requirements for 510(k) submissions might have been different, and the information contained in this summary does not include the type of detailed performance data and study design requested in your prompt.

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