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Ureteral catheters are indicated for access and catheterization of the urinary tract, including applications:

• Delivery of contrast media
• Drainage of fluids from the urinary tract
• Delivery of irrigation fluids to the urinary tract
• Navigation of a tortuous ureter
• Access, advancement, or exchange of wire guides (open-ended catheters only)

The Pediatric Ureteral Catheter is indicated for access and catheterization of the urinary tract in pediatric patients, including the following applications:

• Delivery of contrast media
• Drainage of fluids from the urinary tract
• Delivery of irrigation fluids to the urinary tract
• Navigation of a tortuous ureter

The Ureteral Catheter family is comprised of nine different types of Ureteral Catheters. The types of catheters include: Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, and Pediatric Ureteral Catheter. The Ureteral Catheters range in length from 10 to 125 cm. The catheters may be closed or open-ended. The Ureteral Catheters are sterile, single-use devices.

The provided text describes a 510(k) premarket notification for a family of ureteral catheters. It focuses on demonstrating substantial equivalence to predicate devices, primarily through performance and biocompatibility testing. However, it does not contain the information required to answer your specific questions regarding an AI/algorithm-based device and its acceptance criteria, such as a table of accuracy metrics, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance.

The document is for a traditional medical device (catheters) and not an AI/ML-driven diagnostic or assistive system. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering performance tests and biocompatibility, not AI performance metrics.

Specifically, the document states:

• Performance Testing: "Performance - Testing shows that the subject device conforms to the performance testing requirements based on intended use. All predetermined acceptance criteria were met." (Page 6)
• Biocompatibility Testing: "Biocompatibility – Testing shows that the subject device conforms to the biocompatibility requirements based on its intended use. All predetermined acceptance criteria were met." (Page 6)

The tests performed are typical for a physical medical device: Tensile Strength, Leakage and Lumen Blockage, Radiopacity, Kink Radius, Catheter-Hub Bond, Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity.

To directly answer your request based on the provided text, the following information is NOT available:

1. A table of acceptance criteria and the reported device performance (for an AI/ML device): The document lists performance tests for a physical device, not AI performance metrics like sensitivity, specificity, or AUC.
2. Sample size used for the test set and the data provenance: No information on test data, as it's a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to this type of device.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for physical ureteral catheters and does not contain any information about AI/ML device performance or the study design for such a device.

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