(95 days)
The Amsco Warming Cabinet is designed to raise the temperature of blankets, linens and sterile surgical irrigation solutions and IV solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.
The Amsco Warming Cabinet is designed to store and warm sterile IV solutions, surgical irrigation solutions, linens and/or blankets to an acceptable level for hospital and surgical outpatient center applications. The upper compartment of the 18" (457mm) deep model holds up to 24(1-liter) liquid bags or bottles and 14 (1-liter) IV solution bags; the lower compartment holds up to 72 (1-liter) liquid bags or bottles. The upper compartment of the 24" (610mm) deep model holds up to 30 (1-liter) surgical flasks; the lower compartment holds up to 90 (1-liter) surgical flasks.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria.
The document is a 510(k) premarket notification for a medical device called the "Amsco Warming Cabinet." It primarily discusses the substantial equivalence of this device to predicate devices and its intended use. While it includes a table comparing technological characteristics of the proposed device against predicate devices, this table focuses on features and specifications rather than acceptance criteria for performance studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide details related to sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.
§ 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).