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Extension sets are for administering fluids from container to a patient's vascular system through a vascular access device.

Needleless valve allows the user to add medication into the without the use of a needle.

Power Injection Rating and Flowrate (400 psi and 10 mL/sec).

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The provided text is related to an FDA 510(k) clearance for a medical device called "FlowArt," an intravascular administration set. This document is a clearance letter and does not contain information about acceptance criteria or specific studies that prove the device meets those criteria.

Therefore, I cannot provide the requested information based on the input text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, or adjudication methods for a test set.
3. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
4. Information on standalone algorithm performance.
5. The type of ground truth used.
6. Sample size or ground truth establishment for a training set.

The document primarily focuses on the regulatory clearance process and general controls for medical devices.

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Extension sets are for administering fluids from container to a patient's vascular system through a vascular access device. Used for the removal of particulate matter and elimination of air from infusion fluids while administering. Stopcocks are intended for use to change the direction of fluids through a tubing set. Needleless valve allows the user to add medication into the without the use of a needle.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Flowart" and does not contain the detailed information you requested about acceptance criteria and the study proving the device meets them.

The document primarily focuses on:

• The FDA's determination of substantial equivalence to a predicate device.
• Regulatory requirements and guidelines for the manufacturer.
• The indications for use of the Flowart device (extension sets, stopcocks, needleless valve).

It does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets.
• Information on data provenance, expert qualifications, or adjudication methods.
• Details about MRMC studies, effect sizes, or standalone algorithm performance.
• The type and establishment of ground truth.

Therefore, I cannot fulfill your request with the information provided.

Ask a specific question about this device