(197 days)
The Kangaroo™ Connect Enteral Feeding Pump with Kangaroo™ Connect Feeding Sets delivers nutritional formula to the gastrointestinal system of a patient age infant and older who is physically unable to eat and swallow. Not for use with neonates. The feeding pump and feeding sets are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians.
Enteral feeding pump and disposable enteral feeding sets
I am sorry, but the provided text does not contain the specific information required to generate a table of acceptance criteria and reported device performance for a medical device that meets the requested parameters related to AI/algorithm studies (standalone, MRMC, sample sizes, ground truth establishment, expert qualifications, etc.).
The document is a 510(k) summary for the Kangaroo™ Connect Enteral Feeding Pump and Kangaroo™ Connect Feeding Sets. It details the device's intended use, technological characteristics, and nonclinical testing performed to demonstrate substantial equivalence to a predicate device.
While it mentions software verification and validation, and studies on infusion delivery accuracy, it does not describe:
- Specific acceptance criteria with numerical targets for performance metrics.
- A study explicitly designed to prove the device meets acceptance criteria in the context of an AI/algorithm.
- Any AI or algorithm-driven components in the way typically discussed for image analysis or diagnostic support systems. The software mentioned is for operating the pump and setting feed rates, not for making diagnostic or interpretive decisions.
- Sample sizes for test sets (in the context of AI/algorithm evaluation).
- Data provenance for test sets.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set (as no AI training appears to be the focus here).
- How ground truth for a training set was established.
The studies described are typical for an infusion pump, focusing on biocompatibility, stability, human factors, electrical safety, software verification, battery evaluation, infusion accuracy, fluid ingress protection, and sensor performance. These are functional and safety performance tests for a physical medical device, not evaluative studies for an AI/ML algorithm's diagnostic or predictive performance.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).