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The enteral specific transition connectors are intended to facilitate enteral specific connections between ISO 80369-3 compliant connectors and non-ISO 80369-3 compliant legacy enteral connectors.

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The provided FDA document, K220165, describes a premarket notification for an Enteral Transition Adaptor. This device is a component of a medical system and not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study proving device meets acceptance criteria" as it relates to performance metrics for AI/ML algorithms, ground truth establishment, training/test sets, expert adjudication, or comparative effectiveness studies with human readers, does not apply to this regulatory submission.

The FDA 510(k) clearance process for devices like the Enteral Transition Adaptor focuses on establishing substantial equivalence to a predicate device. This typically involves demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or if there are different technological characteristics, that they do not raise different questions of safety and effectiveness.

The document states:

• Trade/Device Name: Enteral Transition Adaptor
• Regulation Number: 21 CFR 876.5980
• Regulation Name: Gastrointestinal tube and accessories
• Regulatory Class: Class II
• Product Code: PIO
• Indications for Use: The enteral specific transition connectors are intended to facilitate enteral specific connections between ISO 80369-3 compliant connectors and non-ISO 80369-3 compliant legacy enteral connectors.

Therefore, the standard questions related to acceptance criteria and studies for AI/ML performance (such as those outlined in your prompt) are not applicable here. The "study" proving the device meets acceptance criteria would be a demonstration of its compatibility and fit with the specified connectors, and its adherence to relevant standards for medical device accessories, rather than a performance study involving diagnostic accuracy.

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The Enteral Extension Sets with ENFit small bore connectors are intended for enteral feeding, on the order of a physician, to provide a means of delivering enteral nutrition or medication from an enteral feeding syringe through to any feeding tube which will accept a connector for enteral applications.

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The provided text is a 510(k) clearance letter from the FDA for "Enteral Extension Sets." It does not contain information about the engineering details of the device's acceptance criteria, nor does it describe any study that proves the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, ground truth establishment, or human reader effectiveness from this document.

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