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MEDICINA enteral feeding tubes and their accessories are dedicated to the nasogastric and orogastric administration of liquid nutritional media, through the gastro intestinal tract of neonatal and pediatric patients.

MEDICINA feeding tubes is a complete range of devices intended to the gastro-intestinal feeding of patients, with liquid nutritional media. These feeding tubes are available in several sizes (diameter and length), and two materials: PolyUrethan (PUR) and silicon (SIL). They are equipped with connecting elements that does not incorporate a Luer, and thus eliminates the risk of inadvertently connecting the system to an Intra Veinous system. The MEDICINA feeding tube features a locking connection which eliminates the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections. Another benefit of the MEDICINA system is that it does not change the technique of the end-user, and therefore it does not require any special training

The provided text describes a medical device, MEDICINA enteral feeding tubes and accessories, but does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, or adjudication methods in the context of a study. The document primarily focuses on establishing substantial equivalence to predicate devices and addressing the risk of misconnection.

Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or details about the study design, as this information is not present in the provided text.

The document states:

• "The bench testing has demonstrated that MEDICINA feeding tubes are functionally equivalent to Nutrisafe2 and Neomed Enteral feeding tubes."
• "Verification tests performed during the design process have shown that MEDICINA feeding tubes meets performance and safety requirements, and are substantially equivalent to the predicate devices."
• "Risk of misconnection between the enteral feeding tube with a 6% luer taper connector used in intravascular device" was addressed by designing connectors that are "bigger by approximately 1 mm compared to a standard IV 6% luer taper female connector." This was "demonstrated in our report RAES10042009 rev 02 attachment III EN1615 section 4.2.1. (copy attached)."

These statements indicate that testing was performed, but they do not provide the detailed parameters (acceptance criteria, specific performance metrics, sample sizes, expert involvement, etc.) you've requested. The focus is on demonstrating "functional equivalence" and "substantial equivalence" through bench testing and compliance with standards (e.g., EN 1615), rather than a specific clinical or performance study with detailed acceptance criteria and reported metrics typically seen in AI/algorithm-focused evaluations.

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