(113 days)
The Metron QA-IDS Infusion Pump Tester is designed for use by trained service technicians, for testing all types of infusion purips. Tests include volumetric tests, and occlusion tests. The Metron-QA-IDS Infusion:Putmp;Tester is designed to be used by trained service technicians.
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This document is a 510(k) clearance letter from the FDA for a device called "Metron QA-IDS I.V. Pump Tester." It does not contain the kind of detailed study information (acceptance criteria, performance data, sample sizes, ground truth, etc.) that you are asking for. It's a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot extract the requested information from the provided text. The document is for a medical device that tests infusion pumps, not an AI or diagnostic device that would typically have the kind of performance metrics you've listed.
§ 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).