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These instruments are intended for use by qualified surgeons and are used for the infusion of sterile irrigation solution into the ureter and upper urinary tract, or used as a suction pump in conjunction with the Calcuson Ultrasonic Lithotriptor.

The Karl Storz Uropump and accessories is a roller type irrigation/aspiration pump with user adjustable irrigation flow rate, irrigation pressure, and aspiration suction flow rate.

This document describes a 510(k) premarket notification for the Karl Storz Uropump, a suction/irrigation pump. The core of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, rather than proving independent performance against specific acceptance criteria through extensive clinical studies.

Therefore, the provided text does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth methodologies as one would expect for a more rigorous performance study.

Here's why the requested information is absent based on the provided text:

• Nature of 510(k) Submission: A 510(k) submission focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design principles, materials, indications for use, energy used, and performance characteristics to show that the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness. It's not a de novo approval process requiring extensive clinical trials to establish new performance metrics.
• Device Type: The Karl Storz Uropump is a "roller type irrigation/aspiration pump." For this type of device, substantial equivalence often relies on engineering comparisons, bench testing to confirm fluid dynamics (flow rates, pressures, suction), and adherence to relevant standards, rather than clinical studies with "acceptance criteria" and "ground truth" derived from expert consensus on medical images or outcomes.

To directly address your request given the limitations of the provided text:

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

   • N/A. The document states: "The Karl Storz Uropump system is substantially equivalent to the predicate devices since the basic features and intended uses are the same. The minor differences between the Karl Storz Uropump and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." This statement is the "performance acceptance" for a 510(k) – that its performance is equivalent to an already approved device. Specific numerical acceptance criteria against a defined "ground truth" are not provided.

2. Sample size used for the test set and the data provenance:

   • N/A. No formal "test set" in the context of clinical or diagnostic performance is mentioned. The equivalence is likely based on engineering specifications and bench testing comparing the Uropump to its predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. No expert ground truth establishment for a test set is described.

4. Adjudication method for the test set:

   • N/A. No test set requiring adjudication is described.

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:

   • N/A. This device is a pump, not an AI-assisted diagnostic or imaging device. MRMC studies are irrelevant here.

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

   • N/A. This is not an algorithm or AI device.

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

   • N/A. The "ground truth" for a device like this would be its functional specifications (e.g., accurate flow rate, reliable pressure, sufficient suction) as demonstrated through engineering tests, compared against the predicate device. These details are not in the summary.

8. The sample size for the training set:

   • N/A. There is no "training set" as this is not a machine learning or AI device.

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

   • N/A. Not applicable.

In summary, the provided 510(k) summary focuses on demonstrating "substantial equivalence" of the Karl Storz Uropump to existing predicate devices. It explicitly states that "the basic features and intended uses are the same" and "minor differences... raise no new issues of safety and effectiveness... have no effect on the performance, function or intended use." This is the primary "proof" for this type of submission.

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