Search Results

The Extension Feeding Set with ENFit™ connectors is intended for use as an extension set for a Low-Profile Gastrostomy Replacement Tube (G. Button). It is intended to provide delivery of Enteral Nutrition from administration media with ENFit™ connector and or medication into a single patient, for a maximum of two weeks.

Feeding via an Extension Feeding Set is advocated when nutrition cannot be provided to the patient by mouth and therefore cannot consume an adequate number of calories because of an underlying condition.

The Extension Feeding Set with ENFit™ connectors (Extension Feeding Set), comprises a hollow tube with two different connectors at each end: an ENFit™ connector connecting to an administration media, the other is a secure lock connector for connecting to a gastric feeding device.

The Extension Feeding Set is sterile, single patient use device, consisting of a polyvinylchloride tube, ABS secure lock connector, Tritan ENFit™ connector. The connectors on the proximal end of the extension sets are ENFit™ ISO 80369-3 compliant. The ENFit™ connector allows for connections of enteral specific applications while reducing the likelihood of misconnections to non-enteral devices. Extension Feeding Sets are available in three lengths: 5 cm (2"), 30.5 cm (12") or 61 cm (24"). All Extension Feeding Sets are available with either a right-angle secure lock connector or a straight secure lock connector. Both connectors are compatible with G. Button.

The provided FDA 510(k) clearance letter and summary for the "Extension Feeding Set with ENFit™ connectors" (K250481) pertains to a physical medical device (gastrointestinal tube and accessories). Therefore, it does not include information on acceptance criteria, studies, or ground truth establishment relevant to an AI/ML-based medical device.

The questions you've asked (about acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, training set information) are all highly specific to the evaluation and validation of AI/ML-driven devices, particularly in image analysis or diagnostic support.

Since the provided document describes a physical Class II medical device (a tube with connectors), the clearance process for it focuses on:

• Substantial Equivalence: Comparing its design, materials, and technological characteristics to an existing legally marketed predicate device.
• Non-Clinical Testing: Laboratory tests to ensure physical performance (e.g., tensile strength, leakage, flow rate, biocompatibility) and safety based on relevant industry standards (e.g., ISO 80369-3 for ENFit connectors).
• Shelf Life Validation: Ensuring the device remains functional and sterile over its stated shelf life.

Therefore, I cannot extract the requested information (acceptance criteria, study details for AI/ML device validation) from the provided text because it describes a different type of medical device.

If you have a document describing an AI/ML-based medical device, I would be happy to analyze it for the specific details you've requested.

Ask a specific question about this device