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The Bard® AquaGuide™ Ureteral Conduit is indicated for use in endoscopic urology procedures where ureteral dilation and continued ureteral access is desired for injection and aspiration of fluids and insertion and removal of endoscopes and related instruments.

The Bard® AquaGuide™ Ureteral Conduit is a two-component ureteral dilation system which contains multiple lumens for injection and aspiration of fluids as well as passage of endoscopes and related instruments. The system consists of a hydrophilic-coated introducer with female luer connector and a hydrophilic-coated dual-lumen sheath with multi-function access hub. The system is available in three lengths: 25, 35 and 55cm and with either a 10Fr. Introducer with 12-14 Fr. sheath or a 12 Fr. Introducer with 14-16 Fr. sheath.

The provided text describes a 510(k) summary for the Bard® AquaGuide™ Ureteral Conduit, focusing on its substantial equivalence to a predicate device, the Applied Medical Ureteral Access Sheath Set. It does not contain information about acceptance criteria or a study proving device performance against such criteria in the context of an AI-powered device.

The information provided is for a traditional medical device (a ureteral conduit), and the regulatory submission is based on demonstrating substantial equivalence to a predicate device through a comparison of technological characteristics and intended use. Performance data summary in this context refers to the comparison of features, not a clinical study with quantitative performance metrics for AI.

Therefore, I cannot fulfill the request as it asks for details about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI device performance, which is not present in the provided document.

Here's why the provided text doesn't fit the request:

• No AI Device: The device described is a physical medical instrument (Ureteral Conduit), not an AI-powered diagnostic or therapeutic system.
• No Quantitative Performance Metrics: The "Performance Data Summary" is a table comparing features like size ranges and materials to a predicate device. It does not include acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or reported device performance in those terms.
• No Clinical Study Details: There is no mention of a study design, sample sizes (for test or training sets), expert adjudication, ground truth establishment, or multi-reader multi-case studies, which are all typically associated with proving the performance of AI algorithms.
• Regulatory Pathway: The K030438 submission is a 510(k), which relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive de novo clinical trials to prove novel performance metrics (which would be more common for an AI device).

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