(23 days)
The GemStar™ Infusion Pump is indicated for intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the Abbott GemStar™ I.V. Infusion Pump, which primarily states that the device is substantially equivalent to previously marketed devices.
It does not include:
- A table of acceptance criteria or reported device performance.
- Information about sample sizes for test sets, data provenance, or details about the experts and ground truth establishment for a study.
- Details about adjudication methods, MRMC studies, or standalone algorithm performance.
- Information on the training set or how its ground truth was established.
This document is a regulatory approval, not a technical report or scientific study detailing the device's specific performance metrics against an acceptance criterion.
§ 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).