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The ENFit Adaptor is intended for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel.

To facilitate the interconnection between newly-released feeding sets, which are equipped with female ENFit connectors, and the funnel feeding ports of previously-designed enteral feeding tubes, the proposed device is designed with the mating component of an ENFit female connector, designed and tested in accordance with ISO 80369-3 and ISO 80369-20, at one of its ends, and the mating component of a non-ISO 80369-1 compliant funnel feeding port, a stepped tip connector, at its other end. It can prevent an interruption or delay in patient care by allowing fitment of enteral feeding sets with ISO 80369-3 compliant ENFit female connectors to existing enteral feeding tubes with non-ISO 80369-1 compliant end connectors, referred to as "funnel feeding ports" which are still available for use in healthcare setting.

The proposed device is sterile or non-sterile device is sterilized by ethylene oxide to achieve a SAL 10- and supplied in sterility maintenance package which maintain the sterility of the device during the shelf life 5 years.

No DEHP, BPA and Natural Rubber Latex are added in the device.

The provided text is a 510(k) summary for the ENFit Adaptor, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device. Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment relevant to an AI/ML device from this document.

The document discusses non-clinical tests to verify design specifications and compliance with various ISO standards for mechanical performance, biocompatibility, sterilization, shipping, and shelf-life of the physical adaptor. These tests are performed to demonstrate that the device itself is safe and effective as a physical connector, not as an AI-powered diagnostic or therapeutic tool.

For instance, the document mentions:

• Performance tests: Fluid Leakage, Stress Cracking, Resistance to Separation from Axial Load, Resistance to Separation from Unscrewing, Resistance to Overriding, Disconnection by Unscrewing, Connector Incompatibility Test, Materials Used for Small-bore Connectors, Dimensional analysis, Compatibility and Usability Test.
• Biocompatibility tests: Cytotoxicity, Irritation, Skin Sensitization.
• Sterilization, Shipping and Shelf-Life tests: Ethylene oxide sterilization residuals, seal leak detection, seal strength, seal integrity, Bacterial Endotoxins Test.

These are all physical and chemical property tests for a medical device connector, not performance metrics of an AI/ML algorithm.

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The Nutrisafe 2 – ENFit adaptor is indicated for enteral use only. It enables the connection between an administration set equipped with a female ENFit connector at its distal end and a Nutrisafe 2 feeding tube equipped with a male Nutrisafe 2 connector at its proximal end.

The Nutrisafe 2 – ENFit adaptor is indicated for enteral use only. It enables the connection between an administration set equipped with a female ENFit connector at its distal end and a Nutrisafe 2 feeding tube equipped with a male Nutrisafe 2 connector at its proximal end. Vygon has not previously submitted any 510(k)s for the subject device.

The provided text is a 510(k) summary for the "Nutrisafe 2 - ENFit Adaptor" device. It describes the device's indications for use, technological characteristics, and non-clinical testing. However, it does not contain information about acceptance criteria or a study proving the device meets such criteria in the context of an AI/ML device.

The document refers to a "non-clinical verification" through "bench testing" that confirmed physical attributes and device performance meet "the requirements of standards performance." It lists several tests that were performed (dimensional analysis, fluid leakage, stress cracking, resistance to separation, resistance to overriding, disconnection by unscrewing, flow testing, and misconnection risk analysis). However, it does not specify the numerical acceptance criteria for each of these tests, nor does it provide the detailed results of these tests.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving an AI device's performance. The document describes a traditional medical device (an adaptor) and its regulatory submission, not an AI/ML powered device.

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