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Pressure Rated: The Q2® Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second.

Non Pressure Rated: The Q2® Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration.

Sterile, single use non-pyrogenic intravenous administration extension set comprised of 5.75 inch tubing bonded to a male luer on one end and a T-connector on the other end with a clamp in between. The T-connector has a female luer on one side and a swabable, needle-free port on the other side. This device is not made with the plasticizer Diethylhexylphthalate (DEHP). The Velano Vascular Q2® Extension Set is compatible with PIVO™ devices.

This document is a 510(k) Premarket Notification for a medical device (Velano Vascular Q2 Extension Set), which focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI/ML device meets specific performance criteria through a rigorous study. Therefore, the information typically required to answer your prompt about AI acceptance criteria and study details (such as sample size for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance) for an AI/ML device is not present in this document.

This document describes a traditional medical device (an intravascular administration set) and performs mechanical and functional testing to demonstrate its safety and effectiveness relative to a legally marketed predicate device.

However, I can extract the relevant information regarding the device's functional and safety testing, despite it not being an AI-driven device.

Here's a breakdown of the acceptance criteria and study information provided in the document:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly present a table of "acceptance criteria" against "reported performance" in a quantitative manner for each test. Instead, it lists the types of functional and safety tests performed and states that these tests ensured the device design meets its functional and performance requirements. The conclusion explicitly states that "Velano Vascular considers the Velano Vascular Q2® Extension Set device to be substantially equivalent to the predicate device listed above. This conclusion is based upon the intended use, design specifications, patient contacting materials, manufacturing and sterilization processes." This implies that the device met the implicit acceptance criteria for each test to achieve substantial equivalence.

Implicit Acceptance Criteria and Demonstrated Performance (Inferred from the document):

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