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The BioNavigation System for Placement of Enteral Feeding Tubes is intended to be assure to and in action information of the tube tip as it moves through a patient during the tube placement procedure.

The BioNavigation System for Placement of Enteral Feeding Tubes is designed to aid in the placement of an enteral feeding tube by providing a clinician with real-time information as to the location and direction of the tube tip during the placement procedure. Commonly used anatomical external markers used in auscultation procedures allow the clinician to approximate the internal position of the tube tip. Final tube position is confirmed using standard institutional procedures (x-ray, aspiration, or auscultation).

The system includes a sensor device permanently mounted inside a sensor stylet (MAPCath) and an electronic transmitter / receiver instrument (NAVIGATØR) that emits low level electromagnetic signals that are sensed by the sensor device in the tip of the stylet. Prior to initiation of the enteral feeding tube insertion procedure, the MAPCath sensor stylet is positioned inside the lumen of the enteral tube adjacent to the standard stylet supplied with the tube. The sensor in the tip of the stylet is positioned near the tip of the tube and the stylet is locked in place.

As the instrument is moved in the proximity of the sensor the instrument measures the change in response of the sensor and determines the relationship between the position of the sensor and the position of the instrument . The instrument provides an audible and visual display indicating when the NAVIGATØR instrument is positioned directly over the tube tip and also provides an indication of the direction the tube tip is pointing.

The provided document, "Navion Biomedical Corp. Premarket Notification Information", primarily describes a new medical device and seeks a substantial equivalent determination from the FDA. It details the device's purpose, operational mechanism, and comparison to a predicate device. However, it does not contain information on acceptance criteria, a study proving device performance against such criteria, sample sizes for testing or training, expert qualifications for ground truth, adjudication methods, or results of MRMC or standalone studies.

The document is a Premarket Notification (510(k)) submission, which is typically a preliminary step for new devices to demonstrate substantial equivalence to a legally marketed predicate device, rather than a detailed report of a clinical trial proving specific performance criteria.

Therefore, I cannot provide the requested information based on the given input. The document focuses on the description of the device and its intended use, not on specific performance metrics or the studies required to establish them.

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The 1.4 Fr MAPCath Sensor Stylet is designed to be used with the NAVIGATOR Cathotors (CVCc) by indicating the position and direction of the CVC tip inside the body during the catheter insertion procedure.

The sensor stylet described in this 510(k) submission is the same product described in Bard Access Systems 510(k) (reference K935380).

I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) summary for a medical device (1.4 Fr MAPCath sensor stylet) and focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as you've requested.

The document states:

• The device is "substantially equivalent (same product) to the 1.4 Fr sensor stylet described in Bard Access Systems submission K935380 and substantially equivalent in design, use and function to the Navion SMART-WIRE sensor described in submission K901263."
• "The sensor stylet described in this 510(k) submission is the same product described in Bard Access Systems 510(k) (reference K935380)."

This indicates that the submission relies on the prior clearances and the equivalence of the device, rather than presenting new performance study data against defined acceptance criteria.

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