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Mobility+ is intended to deliver liquid nutrition formula, to an enteral access device (feeding tube) in users aged 2 years and over.

The Mobility+ Enteral Feeding System ("Mobility+" or the "System") is a portable, lightweight, nonelectronic, disposable enteral feeding system intended to deliver liquid nutrition formula to an enteral access device (feeding tube) in users aged 2 years and over in the clinical or home care settings. The device is for single patient use, disposable and intended for use over a 24 hour period. The System has three primary components; food pouch, filling set and giving set.

The provided text describes the regulatory submission for the Mobility+ Enteral Feeding System, a medical device. It does not contain information about an AI/ML-driven device or a study involving acceptance criteria for an AI algorithm's performance. The document focuses on demonstrating substantial equivalence to a predicate device using bench testing and non-clinical data, not on the performance of a software algorithm.

Therefore, I cannot extract the information required to populate the fields related to AI/ML device performance, ground truth, expert adjudication, or MRMC studies, as these concepts are not applicable to the descriptions within your input.

The document explicitly states:
"Clinical studies were not deemed necessary for The Mobility+ Enteral Feeding Set as bench testing was sufficient to demonstrate substantial equivalence by way of comparison to a legally marketed predicate device."

This indicates that the study performed was a non-clinical bench testing and design verification/validation study to demonstrate that the physical device performs as intended and is equivalent to existing devices, not a study evaluating an AI algorithm's diagnostic or therapeutic capabilities.

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