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The UROMAT E.A.S.I. is used for the introduction of irrigation fluids into organs and operating fields as well as the suctioning off of irrigation and bodily fluids, secretions and tissue during endoscopic interventions.

The UROMAT E.A.S.I. is a peristaltic (double roller), microprocessor controlled, irrigation and suction pump with continuous fluid flow for urological interventions. Alternatively, the two pumps can be flowoperated independently of each other for flow regulation, e.g., for laparoscopic interventions.

The provided text is a 510(k) summary for the Karl Storz UROMAT E.A.S.I. device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific, quantitative acceptance criteria through a clinical study or a standalone algorithm performance study.

Therefore, the document does not contain the information requested regarding acceptance criteria and the rigorous study design typically associated with proving a device meets those criteria for an AI/ML or diagnostic device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm. The "Performance Data" section solely lists non-clinical testing for electrical safety, EMC, software verification/validation, usability, and biocompatibility/sterilization for tubing sets.
• Sample size, data provenance, number of experts, adjudication methods, or ground truth details for a test set. This is because no such study (e.g., relating to diagnostic accuracy, image analysis, or AI assistance) is described.
• Details on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance. The device is an irrigation and suction pump, not a diagnostic imaging device or an AI application.
• Training set details (sample size, ground truth establishment). As it's not an AI device, there's no mention of a training set.

Summary of what is present in the document relevant to device performance (but not in the requested format for an AI/ML device):

The document details the device's technical specifications and compares them to predicate devices to demonstrate substantial equivalence. Key performance parameters listed are:

• Irrigation Pressure: 20-200 mm Hg for Continuous Flow (CF), Single Flow (SF)
• Irrigation Flow: 10-250 ml/min for Continuous Flow (CF)
• Suction Flow: 100-1800 ml/min for Suction/Irrigation and Lithotripsy
• Overpressure Safety: Software prevents pressure over 200 mm Hg (hardcode); Hardware alarm at >240 mm Hg.

These are functional specifications and safety features, not acceptance criteria for an AI/ML performance study as implied by your request.

Conclusion based on the provided text:

The information in the 510(k) summary (K162992) for the Karl Storz UROMAT E.A.S.I. pertains to a fluid management device (irrigation and suction pump). It focuses on demonstrating substantial equivalence to predicate devices through technical specifications and basic non-clinical testing. It does not describe an AI/ML component or a study to prove meeting acceptance criteria for such a component, therefore, it cannot provide the requested details about acceptance criteria, test sets, expert adjudication, or AI model performance studies.

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