Search Results

The EZ-Connect is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container into the patient.

The EZ-Connect is an extension set comprised of 150 mm of tubing with a right angle luer lock connector and cap on one end, a standard straight luer lock connected to a needleless connector on the other end and a pinch clamp in the middle.

The provided text is a 510(k) summary for a medical device (EZ-Connect Extension Set) and does not contain information about a study with acceptance criteria for device performance as a diagnostic or AI-driven tool. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request for creating a table of acceptance criteria and device performance, or details about sample sizes, ground truth, experts, MRMC studies, or standalone performance, as this information is not present in the provided document.

The document primarily states:

• Conclusion: "The EZ-Connect Extension Set meets the functional claims and intended use as described in the product labeling, and is as safe and effective in terms of substantial equivalence as the predicate Codan Extension Set Light-Safe Model BC 565."
• Comparison Areas: The device was compared to the predicate in areas such as Biocompatibility, Design features, Indications for use, Standards met, Sterility, Target population, and Where used.

These points indicate a regulatory pathway focused on comparison to an existing device rather than a performance study with specific quantifiable acceptance criteria as might be seen for a diagnostic or AI device.

Ask a specific question about this device