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The Gabriel Feeding Tube with balloon functions as a conduit to facilitate enteral feeding, and may be used in adult or elderly patients who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with functioning gut who require short to moderate term feeding support, such as post-trauma patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exist, or may result, secondary to an underlying disease or condition.

The Gabriel Feeding Tube with Balloon serves as a conduit through which enteral feeding solutions are directly infused into the patients small bowel. During placement of the tube, a lubricant and or numbing gel is applied to the nostril.

For the version of the tube with stylet with magnetic tips, an external magnet is used to assist the physician in placing the tube into the small bowel. Like the predicate device, the modified device has a stylet with a reed switch positioned near its distal tip. The reed switch is connected by wires to an external LED/battery pack that lights in response to the presence of the external steering magnet. The reed switch is encased in a lead-free glass tube and metal shield and is attached to the distal end of the stylet. The wires used to connect the distal reed switch to the LED are polyurethane insulated copper and are wrapped around the core of the stylet and contained inside the outer PTFE layer, thus keeping it out of the fluid path. The distal tip of the stylet contains magnets which are attracted to the steering magnet. The inflated feeding tube balloon allows peristalsis to advance the feeding tube distally.

For the version of the tube with the non-magnetic stylet, the tube is manually inserted by the physician. The stylet, is non patient contacting, made out of seven braided filaments 305 stainless steel wire and is 3 cm shorter than the feeding tube.

The stylet is removed and tube taped at the nose and placement verified by pH paper and abdominal x-ray. Like the predicate device, the modified Gabriel Feeding Tube with Balloon has a stylet. The inflated feeding tube balloon allows peristalsis to advance the feeding tube distally.

The external tube is extruded over reinforcing monofilament stainless steel wire that prevents occlusion by kinking. The outer patient contacting layer is made from DEHP-free PVC.

This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, the "Gabriel Feeding Tube with Balloon." It is not a study proving a device meets acceptance criteria using AI or advanced analytical methods. The document primarily focuses on establishing substantial equivalence to predicate (already approved) devices through non-clinical testing and biocompatibility assessments. Therefore, I cannot extract the information required to populate a table of acceptance criteria and reported "device performance" in the context of an AI/ML or a complex diagnostic device, nor can I describe a study that proves the device meets these criteria in that framework.

Here's why I cannot provide the requested information from this document:

• Device Type: The Gabriel Feeding Tube with Balloon is a physical medical device (a tube for enteral feeding), not a diagnostic or AI/ML-based device.
• Approval Pathway: The 510(k) pathway establishes "substantial equivalence" to existing devices, meaning it's as safe and effective as something already on the market. It doesn't typically involve new, large-scale clinical trials or the type of "acceptance criteria" and "performance metrics" associated with complex algorithms (like sensitivity, specificity, AUC).
• Testing: The listed "Non-Clinical Testing" focuses on physical properties (pull strength, flexibility, flow rate, leakage, tensile strength), biocompatibility, and comparison to predicate devices, not on diagnostic accuracy, human reader improvement, or algorithm-only performance.
• No AI/ML Component: There is no mention of any artificial intelligence, machine learning, or automated diagnostic component in this device or its testing.
• No Clinical Study Performed for this Submission: The document explicitly states: "No clinical testing was performed in association with this submission." This means there's no data from human subjects on efficacy or performance metrics in a real-world clinical setting presented here.

In summary, this document does not contain the kind of information (AI performance metrics, human reader study data, detailed ground truth establishment, training set details) that your prompt is asking for.

If you have a document describing an AI/ML-based device or a diagnostic device, I would be happy to help you extract that information.

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