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The devices are indicated for the delivery of fluids from a container to a patient's vascular system.

The proposed devices are indicated for the delivery of fluids from a container to a patient's vascular system through the infusion needle under the action of gravity. The proposed devices are comprised of air filter, protective cap of closure-piercing device, closure-piercing device, drip chamber, flexible tubing, flow regulator, filter and an infusion needle attached to a luer adaptor. For the Burette-type Infusion Sets for Single Use, an additional component of burette can used for quantitative infusion. For Disposable Infusion Sets with Precision Filters, a precision membrane is provided for filtration operation.

I am sorry, but the provided text does not contain the information required to answer your request. This document is a 510(k) premarket notification summary for medical devices (infusion sets). It outlines the device description, indications for use, comparison to predicate devices, and non-clinical test conclusions to establish substantial equivalence.

It does not include:

• A table of acceptance criteria and reported device performance beyond general compliance with ISO standards.
• Details about a specific study proving the device meets acceptance criteria, such as sample sizes, data provenance, ground truth establishment, or expert qualifications.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot provide the requested information based on this text.

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