(60 days)
The MedSource IV Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "MedSource Selectable IV Set." This document confirms the device's substantial equivalence to legally marketed predicate devices.
However, the letter does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML powered medical device. It is a regulatory clearance document for a physical medical product (an IV set), not a software or AI product.
Therefore, I cannot provide the requested information based on the given input. The categories in your request (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance") are typically associated with performance studies for AI/ML diagnostic or assistive technologies, which are not described in this document.
§ 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.