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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).

Not Found

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.

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).

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details that would enable me to answer your request. The document is an FDA 510(k) clearance letter for a medical device called "NeutrArt," an intravascular administration set. It discusses regulatory matters, indications for use, and administrative information, but it does not include clinical study data or performance metrics.

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

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

This document is a 510(k) clearance letter for the NeutrArt device, which is an intravascular administration set. It provides regulatory information and indicates that the device has been found substantially equivalent to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

Therefore, I cannot provide a response based on the input text. Please provide a document that contains information about the device's technical specifications, performance studies, and validation processes.

Ask a specific question about this device