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The intended use of the proposed device is for the intravascular administration of fluids and medication by trained health care personnel. The administration of fluids is achieved through gravity from collapsible or non-collapsible fluid containers through a venipuncture device (not included in the proposed device).
The device is used to supply medication and fluids intravascularly to patients through a needle or catheter inserted into the vein.

The proposed administration set will be used for intravascular administration of fluids and medication. The proposed device contains a vent with filter such that it can be used with non-collapsible fluid containers. The vent also has a cap to close the vent when using a collapsible fluid container (e.g., IV bag) which does not require a vent. The proposed device also contains an injection site 8 in. from the distal luer slip connector.

The provided text describes a 510(k) submission for a medical device, the PARSET® I.V. Administration Set. The document focuses on demonstrating substantial equivalence to a predicate device and fulfilling regulatory requirements. It details non-clinical tests but does not include information typically found in acceptance criteria or study reports for an AI/ML powered device.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or AI/ML study details because this document pertains to a traditional medical device submitting for 510(k) clearance, not an AI/ML device.

Here's why the information cannot be extracted:

• No AI/ML Component: The device described is an I.V. administration set, an entirely mechanical device. There is no mention of any software, algorithm, or AI/ML component.
• Non-Clinical Testing: The "Discussion of Non-clinical Tests" refers to compliance with ISO standards for infusion equipment, biocompatibility, packaging, and sterilization – all physical device characteristics. These are not related to algorithm performance.
• Regulatory Pathway: A 510(k) submission for a device like this focuses on demonstrating "substantial equivalence" to a predicate device, primarily through engineering and materials testing, not through clinical or algorithm performance studies with ground truth.

If you have a document describing an AI/ML device, I would be able to extract the requested information.

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