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The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

IV Administration Sets are gravity, single use, disposable, intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, luer access device, stopcock, manifold, tubing, luer connections (connector, adaptor), filter, and hand pump. IV Administration sets are configured to ensure the intended use of the device is met.

The provided text is a 510(k) summary for an IV Administration Set (K213778). It describes the device, its intended use, comparison to a predicate device, and nonclinical testing performed to demonstrate substantial equivalence.

However, the request primarily asks about acceptance criteria and a study proving a device meets acceptance criteria, specifically in the context of an AI/Software as a Medical Device (SaMD). The document furnished details on a physical medical device (IV Administration Set) and its substantial equivalence to a predicate through bench testing and adherence to ISO standards.

Therefore, the information required to answer the prompt regarding AI/SaMD acceptance criteria and proof of performance (e.g., sample size, expert ground truth, MRMC study, standalone performance) is not present in the provided text. The document clearly states: "No clinical testing was performed as these devices does not require clinical studies to demonstrate substantial equivalence with the predicate device."

To reiterate, the provided document does not contain the information requested in your prompt regarding AI/SaMD performance studies and acceptance criteria. This device is a physical IV administration set, not an AI/SaMD.

If you can provide a document related to an AI/SaMD, I would be happy to help answer your questions.

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