Search Results

The Veritract Enteral Feeding Tube System is intended for use in those patients who require intermittent or continuous tube feeding via the nasogastric route. The vision and steering provided by the Veritract System is intended as an adjunct to current practices to aid qualified clinicians with experience in placing naso-enteric feeding tubes into the stomach or small bowel of patients requiring enteral feeding. Placement of the tip of the device into the small bowel should only be attempted by clinicians with expertise in small bowel placement. Confirmation of correct tube placement by X-ray or acceptable hospital protocol is required prior to commencing administration. The Veritract Enteral Feeding Tube has not been tested for use longer than shortterm use (

Not Found

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the "Veritract Enteral Feeding Tube System," which indicates that the device has been found substantially equivalent to a legally marketed predicate device.

The letter discusses:

• The device name, regulation number, and product code.
• The FDA's determination of substantial equivalence.
• General controls provisions and other regulations applicable to the device.
• Contact information for various FDA offices.
• The Indications for Use Statement (Section 4), which describes how the device is intended to be used, but not performance metrics or acceptance criteria from a study.

Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, ground truth establishment, MRMC studies, or standalone performance, as these details are not present in the provided document.

Ask a specific question about this device