(64 days)
The US Safety Syringes IV Administration set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
The device may include the tubing, a flow regulator, filter, drip chamber, Y port, needless injection port, backflow valve, fluid delivery tubing, connectors between parts of the set and a hollow spike to connect the tubing to an IV bag or medication bag.
The provided text is a 510(k) summary for a medical device (US Safety Syringes IV Administration Set with Flow Regulator & Filter). It concerns regulatory approval from the FDA.
Based on the provided text, there is no information about acceptance criteria, device performance studies, or any of the detailed aspects requested (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, training set information).
This document describes the regulatory approval process (510(k)) and states that the device is substantially equivalent to legally marketed predicate devices. It does not contain the technical study details you are asking for.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and device performance studies because that information is not present in the provided text.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.