(39 days)
The SoloPak Medical Products, Paragon Infusion Pump and Administration Sets are intended to be used as a system for the purpose of delivering drugs and solutions through an in-dwelling catheter.
The pump is made of two cylindrical high impact plastic shells with a pressure plate assembly in the top shell. It is packaged individually and can be cleaned after each use and reused. The Administration Sets that function with the pump consists of a 110mL PVC drug container, PVC tubing, a fill valve, PVC tubing, an onloff clamp, a 1.2 Micron Filter, a male Luer lock adapter with an integrated flow restrictor and tip protectors. The administration Sets are individually packaged as single use devices in tyvek and mylar pouches. They are EtO stenlized per AAMI guidelines and meet the requirements of the Federal Register Vol. 43, No. 122, June 23,1978, pp 27482-3 for ethylene oxide residuals.
This document is a 510(k) summary for the SoloPak Medical Products Paragon Infusion Pump and Administration Sets. It does not contain the detailed information required to answer your specific questions regarding acceptance criteria and study design for a device's AI performance.
The document discusses the device's technical specifications, intended use, and claims of substantial equivalence to a predicate device based on manufacturing processes and design, not AI performance. It mentions a performance claim related to flow rate accuracy but this is a traditional medical device performance metric, not an AI-related one.
Therefore, an answer fulfilling your request cannot be generated from the provided text.
To answer your questions, I would need a document that describes the development, testing, and validation of an AI-powered medical device, including information on its performance against specific acceptance criteria, details on training and test datasets, ground truth establishment, and if applicable, MRMC studies.
§ 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).