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The Medrad Continuum MR Compatible Infusion System is designed for patients who require maintenance medications and fluids intravenously, during an MR procedure. The Continuum is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure, functioning while stationary or mobile. It is not intended to provide long-term patient care outside of the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

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I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a medical device (Medrad Continuum MR Compatible Infusion System), along with its intended use and indications for use.

This type of document primarily confirms that the FDA has determined the device is substantially equivalent to a legally marketed predicate device. It defines the device, its intended use, and indicates its regulatory class. However, it does not contain details about specific acceptance criteria for performance, study designs, sample sizes, ground truth establishment, or multi-reader multi-case studies. These details would typically be found in the more comprehensive 510(k) submission itself, which is not provided here.

Therefore, I cannot populate the table or answer the specific questions about the study and acceptance criteria based on this text alone.

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