(305 days)
Plum 360™ Infusion System with Hospira MedNet™ is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
The Plum 360TM Infusion System withMedNet / Smart Card Plug 'n' Play Module remains a volumetric Infusion System intended for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products. Dedicated administration sets are used for delivery of infusion therapy to the patient. The device has a user interface consisting of LCD display, front panel alphanumeric keypads and keys, audible and visual indicators, audible indicator volume control, nurse call interface, network interface connectors, the drug library and software that provides pre-defined display screens for therapy programming. The continued use of the MedNet Software allows communication between the Infusion Pump, MedNet server and the facility's communication systems.
This appears to be an FDA 510(k) summary for an infusion pump, which is a medical device and not an AI/ML powered device. This document does not describe acceptance criteria or study results in the context of an AI/ML powered device. Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria, performance, ground truth, or study details from the provided text.
The document discusses:
- Device Name: Plum 360™ Infusion System with MedNet/ Smart Card Plug 'n' Play Module
- Regulation: 21 CFR 880.5725 (Infusion Pump)
- Key Changes: Introduction of a bolus feature, software updates (CPU and Communication Engine), and cybersecurity enhancements.
- Testing: Non-clinical testing, including compliance with IEC standards (60601-1, 60601-2-24, 60601-1-2, 60601-1-8), risk analysis, device safety assurance case, performance testing, human factors evaluations, and software verification and validation.
- Clinical Testing: Stated that clinical evaluation is not required for this submission to support substantial equivalence, though human factors studies were conducted.
The acceptance criteria mentioned are related to meeting these engineering and safety standards for an infusion pump, not an AI/ML system's performance on a dataset. Since the request is specifically for an AI/ML device, and this document pertains to a traditional medical device (an infusion pump), I cannot fulfill the request based on the provided text.
§ 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).