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The Cone Tip Ureteral Catheter is intended for retrograde pyelogram.
The Rutner Universal Wedge Catheter is intended for retrograde pyelogram. The 4.0 Fr Rutner Universal Wedge Catheter is indicated for pediatric population 2 years and older.

Cone Tip Ureteral Catheter: The product consists of a straight, tipped catheter. The distal tip is in a cone formation and intended to temporarily occlude the ureteral orifice. The catheter tip and tubing shaft are made of radiopaque polyvinyl chloride material. The catheter is available in outer diameters of 4.8 and 6.0 French with corresponding tip diameters of 8.0 and 10.0 French respectively. The total working length of the device measures 70 centimeters. All French sizes are available with a closed distal end, except the 4.8 French catheters which are also available with an open end. Catheters with closed distal ends include one side port near the tip, whereas catheters with open distal ends do not include a side port. The radiopaque vinyl tubing shaft has an adapter on the proximal end and incremental graduation marks placed along the distal 50 centimeters of the catheter surface.

Rutner Universal Wedge Catheter: The distal tip is made of polyvinyl chloride radiopaque material and its configuration is designed to occlude the ureteral orifice and stabilize the catheter by temporarily wedging the orifice. The catheter tubing shaft is manufactured from non-radiopaque nylon with an adapter located at the proximal end. The catheter is available in outer diameters of 4.0 or 5.0 French and a total device length of 70 centimeters. The outer diameter of the tip is available in 8.0 and 14.0 French. Based upon the device size, the distal tip may occlude an opening of 3.0 to 8.0 French or 4.0 to 14.0 French, respectively. A single sideport is located in the distal end of the catheter.

The provided document is a 510(k) summary for the Cone Tip Ureteral Catheter and Rutner Universal Wedge Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness in the same way an AI/CADe device would. Therefore, the information typically requested for AI/CADe acceptance criteria and studies (like sample size for test set, number of experts for ground truth, MRMC studies, effect size, etc.) is not present in this document.

However, based on the provided text, I can extract the following information about the performance data that was conducted to ensure the device meets its design input requirements for safety and performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted. The "acceptance criteria" are implied by the successful completion of these tests, leading to the conclusion that the devices "meet the design input requirements based on their intended uses." Specific numerical acceptance criteria are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The performance data section only lists the types of tests conducted.

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 information is not applicable/not provided. The tests conducted are primarily engineering and material science evaluations, not clinical performance assessments requiring expert ground truth in the way an AI/CADe device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. The tests conducted are primarily engineering and material science evaluations.

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

This information is not applicable. This submission is for a medical device (ureteral catheter) and not an AI/CADe device. No MRMC study was mentioned or required.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This submission is for a medical device (ureteral catheter) and not an AI/CADe device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests would be the established engineering specifications, material standards, and industry best practices for each test (e.g., maximum allowable tensile strength, specific kink radius, biocompatibility standards, etc.). These are objective criteria, not clinical "ground truth" derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable/not provided. This is not an AI/CADe device that uses training data.

9. How the ground truth for the training set was established

This information is not applicable/not provided. This is not an AI/CADe device that uses training data.

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