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Recommended for introduction of balloons, catheters and other diagnostic and interventional devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

The NuMED D'VILL Introducer is recommended for introduction of balloons, catheters and other diagnostic and interventional devices. The introducer consists of a dilator, and sheath with hemostasis valve and side port on the proximal end of the sheath assembly. There is a single image band embedded in the distal end of the sheath tubing for imaging purposes. The sheath is Pebax braided with stainless steel and a PTFE liner and will accommodate a 0.035" guidewire. The dilator is LDPE. The D'VILL is available in 10, 12 and 14F sizes and 30 and 85cm lengths.

The document provided is a 510(k) summary for the D'Vill Introducer, a medical device. It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain information about a study proving the device meets specific acceptance criteria based on performance data.

The "Performance Testing" section on page 4 lists several tests performed:

• Surface Inspection
• Size Designation – Sheath and Dilator
• Freedom from Leakage – Sheath and Hemostasis Valve
• Peak Tensile Force - 3 locations
• Strength of Union Between Hub and Dilator
• Dimensional Requirements – Sheath, Stopcock, and Dilator
• Luer Hub Testing
• Kink/Flexibility Testing – Sheath and Dilator
• Sterilization Testing
• Biocompatibility Evaluation – Short duration contact with circulating blood (< 24 hours)
• Shelf Life Testing

The document states, "All tests met their acceptance criteria and specifications." However, it does not provide the specific acceptance criteria for each test or the reported results.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I answer questions related to sample size, ground truth, experts, or comparative effectiveness studies, as this information is not present in the provided text.

The information requested, such as specific performance metrics (e.g., leakage rate, tensile strength values, specific dimensions) and their acceptance thresholds, as well as the actual test results, would typically be found in a more detailed test report or design verification document, which is not included in this 510(k) summary. These summaries focus on demonstrating substantial equivalence rather than providing detailed raw performance data.

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