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The Bard® Dual Lumen Ureteral Catheter is intended to facilitate drainage and retrograde pyelogram of the upper urinary tract. This catheter will allow access to and navigation of a torturous ureter using standard endoscopic techniques.

The Dual Lumen Ureteral Catheter is a bifurcated catheter with one lumen used for the passage of a quidewire and the other lumen used to inject or drain fluids. Each "Y" extension employs a female luer lock fitting used for connection to a syringe. The Dual Lumen is available in 10 Fr. with the catheter tip tapered to approximately 6 Fr. The working length of the catheter is 50 cm.

The provided text describes a 510(k) summary for the Bard® Dual Lumen Ureteral Catheter. It discusses the device's description, intended use, and technological characteristics compared to a predicate device. However, it does not contain specific information about acceptance criteria or a study that rigorously proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or other quantitative measures typically associated with AI/ML or diagnostic devices.

The document states:

• "The Bard® Dual Lumen Ureteral Catheter is constructed with biocompatible materials and has been tested for performance and found equivalent to the predicate device."

This statement implies that performance testing was conducted, and the device was found equivalent, but it does not specify what those performance tests entailed, what the acceptance criteria were, or the results of those tests. There is no table of acceptance criteria or reported device performance with numerical metrics.

Therefore, I cannot provide the requested information from the provided text as it does not contain the details of a study with acceptance criteria and reported device performance, sample sizes, ground truth establishment, or expert involvement as typically required for AI/ML device evaluations.

To reiterate, the document is a 510(k) summary for a medical device that appears to be a physical ureteral catheter, not an AI/ML or diagnostic software device. The questions you've asked are typical for evaluating AI/ML models or diagnostic tests, which rely on data and performance metrics. This document does not provide that kind of evaluation.

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