(51 days)
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.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.