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The Pediatric Nasogastric Feeding Tubes - Single ENFit Port are intended for enteral feeding to deliver nutrition, fluids, and medications to the patient from an enteral feeding syringe or feeding set designed with ENFit connectors for enteral applications. This product is single use for no longer than 29 days.

The Pediatric Nasogastric Feeding Tubes – Single ENFit Ports are intended for hydration, feeding and administration of oral medications for pediatric patients who require enteral feeding. This product is single use for no longer than 29 days.

The Pediatric Nasogastric Feeding Tubes – Single ENFit Port are sterile, single use devices. The feeding tubes consist of a graduated Polyurethane tube, with radiopaque edge. The tubes have a closed tip and 2 lateral eyes. The tubes have at the other end an ENFit male connector in ABS with its Polypropylene cap. A tether in thermoplastic polyurethane connects the ENFit connector to its cap. The ENFit connector allows the device to be connected to female enteral devices that have an ISO 80369-3 compliant connector. The feeding tubes are available in 40mm, 60mm and 90mm lengths and in French sizes from 4 to 12.

The provided text is a 510(k) summary for the Pediatric Nasogastric Feeding Tubes - Single ENFit Port. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of an AI-powered diagnostic device.

Therefore, the information required to answer the questions about acceptance criteria and the study that proves the device meets the acceptance criteria for an AI diagnostic device is not present in the provided text. The document details performance testing for a physical medical device (nasogastric feeding tubes), not an AI algorithm.

Specifically:

• There is no AI device described.
• There are no acceptance criteria for AI performance (e.g., accuracy, sensitivity, specificity).
• There is no mention of a test set, training set, ground truth acquisition involving experts, MRMC studies, or standalone algorithm performance.

The "Performance Testing" section (pages 9-10) describes non-clinical tests performed on the physical feeding tubes, such as biocompatibility, pressure leak testing, tensile testing, and connector performance tests against various ISO standards. It explicitly states, "Clinical tests were not required to demonstrate performance... Product functionality has been adequately assessed by non-clinical tests." and "Animal tests were not required... Product functionality has been adequately assessed by non-animal tests."

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