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This device is intended for injection of contrast medium and/or safety wire guide placement during percutaneous and transurethral access. The catheters that are 24 cm and 40 cm in length can be used in pediatric patients 12 years and over.

The Dual Lumen Ureteral Access Catheter is constructed from a dual-lumen, polyurethane tubing with ink marks and a tubing manifold with extension tubes. The catheter has a working length of 50 cm. The outer diameter of the catheter is 10.0 Fr and both lumens' inner diameter is 0.050 inches. The distal tip is notched to expose one lumen and create a 5.0 Fr tip with the other lumen. This device is manufactured both with and without a hydrophilic coating.

The Flexi-Tip® Dual Lumen Ureteral Access Catheter is constructed from a dual-lumen, polyurethane tubing with ink marks and a tubing manifold with extension tubes. The catheter is available in lengths of 24, 40, and 50 cm. The outer diameter of the catheter is 10.0 Fr and both lumens' inner diameter is 0.050 inches. The distal tip is notched to expose one lumen and a flexible polyurethane tip is bonded to the tip of the other lumen. The Flexi-Tip® Dual Lumen Ureteral Access Catheter is available with hydrophilic coating and a radiopaque urethane tungsten marker. The Dual Lumen Ureteral Access Catheter and the Flex-Tip® Dual Lumen Ureteral Access catheters are sterilized by ethylene oxide and are packaged in peel-open pouches for single use.

This document is a 510(k) summary for the Cook Incorporated Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter. It is a premarket notification for a medical device seeking clearance from the U.S. FDA, not a study report. Therefore, this document does not contain acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or performance study would for an AI/CADe device.

The information provided describes the device, its intended use, comparison to a predicate device, and the types of non-clinical testing performed to demonstrate substantial equivalence. It does not include details on:

• A table of acceptance criteria and reported device performance: This document lists the types of tests performed (e.g., Biocompatibility, Sterilization, Dimensional, Lumen Patency), but it doesn't provide specific quantitative acceptance criteria for these tests nor does it report the detailed results of these tests against any defined criteria.
• Sample size for the test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set information: These are all terms typically associated with studies evaluating the performance of AI/CADe systems or diagnostic devices where human interpretation or machine learning is involved. This document is for a physical medical device (catheter) and therefore these concepts are not applicable.

However, based on the context of a 510(k) submission for a physical device, we can infer some general information about "acceptance criteria" and the "study" demonstrating performance:

Inferred Acceptance Criteria and "Study":

For a physical device like a catheter in a 510(k) submission, "acceptance criteria" are typically defined by engineering specifications, recognized national or international standards (e.g., ISO standards for medical devices, ASTM standards), and comparison to the predicate device's established performance. The "study" refers to a series of non-clinical, bench-top, and sometimes animal studies designed to show that the new device meets these specifications and is substantially equivalent to the predicate.

Here's how we can address your request within the limited scope of this document:

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

The remaining points (2-9) are not applicable to this type of device and document:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - This applies to clinical data or AI/CADe performance data, not bench testing of a physical catheter.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience) - This applies to diagnostic interpretation studies, not physical device engineering tests.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set - Applies to expert review in diagnostic studies.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance - Applies to AI/CADe systems.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - Applies to AI/CADe systems.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc) - Applies to AI/CADe systems or diagnostic accuracy studies.
• 8. The sample size for the training set - Applies to AI/Machine Learning models.
• 9. How the ground truth for the training set was established - Applies to AI/Machine Learning models.

This document is a regulatory submission for a Class II medical device (catheter) based on substantial equivalence to a predicate device, focusing on engineering, material, and performance characteristics rather than diagnostic accuracy or AI performance.

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