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The Karl Storz model 203020 20 Equimat system is designed to monitor the inflow and outflow of irrigation fluid from the urinary tract during endoscopic surgical procedures in urology.
The Karl Storz Equimat is indicated for use in monitoring the volume of irrigation fluid flowing into and out of the urinary tract during endoscopic surgical procedures in urology

The Karl Storz model 203020 20 Equimat is a microprocessor controlled monitoring device designed to be used in conjunction with irrigation/aspiration systems to monitor the volume of irrigation fluid flowing into and out of the urinary tract during endoscopic surgical procedures in urology.

This document is a 510(k) summary for the Karl Storz Equimat, a fluid monitoring system. It does not provide details of a clinical study with acceptance criteria and device performance as typically expected for complex AI/ML devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design and intended use.

Therefore, many of the requested points regarding acceptance criteria, study details, and AI/ML specific information are not applicable or cannot be extracted from this document.

Here's a breakdown of what can be inferred or stated as not applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly provided in the 510(k) summary. The document focuses on "substantial equivalence" rather than presenting specific performance metrics against defined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. No specific test set or clinical study for performance evaluation is described. The submission relies on substantial equivalence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set:

Not applicable. No adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. No MRMC study is mentioned. This device is a fluid monitoring system, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a hardware device for fluid monitoring, not an AI algorithm.

7. Type of Ground Truth Used:

Not applicable. No ground truth for device performance is described in the context of a study. The device's function is to directly monitor fluid, so its "ground truth" would inherently be its accurate measurement against a known standard, which would typically be part of design verification and validation, not necessarily a clinical study needing expert ground truth.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for an AI/ML model, no ground truth for it was established.

Summary from the provided document:

The Karl Storz Equimat is a fluid monitoring system designed to measure the inflow and outflow of irrigation fluid during endoscopic surgical procedures. The 510(k) submission primarily establishes substantial equivalence to existing predicate devices based on its basic features, design, and intended use. It explicitly states that "The minor differences between the Karl Storz Equimat 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 implies that extensive new performance data from a clinical study with defined acceptance criteria was not deemed necessary for this type of device and submission.

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The Karl Storz model 203020 20 Equimat system is designed to monitor the inflow and outflow of irrigation fluid from the uterus during endoscopic surgical procedures in gynecology.

The Karl Storz model 203020 20 Equimat is a microprocessor controlled monitoring device designed to be used in conjunction with irrigation/aspiration systems to monitor the volume of irrigation fluid flowing into and out of the uterus during endoscopic surgical procedures in gynecology.

This document is a 510(k) Summary of Safety and Effectiveness for the Karl Storz Model 203020 20 Equimat, a fluid monitoring system. It declares substantial equivalence to predicate devices but does not contain information about acceptance criteria or a study proving the device meets those criteria. The provided document is a regulatory submission, not a study report. Therefore, I cannot extract the requested information.

Ask a specific question about this device