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The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during general and endoscopic plastic, reconstructive and aesthetic surgical procedures.

The Karl Storz Unimat Plus and accessories is a membrane type irrigation/aspiration pump with fixed irrigation/aspiration flow rate of 3.5 liters/min. and a maximum irrigation pressure of 400 mm Hg.

The given text is a 510(k) summary for a medical device called the "Karl Storz Unimat Plus" system, which is a suction/irrigation pump. This document focuses on establishing the device's substantial equivalence to existing predicate devices based on its intended use and design, rather than proving its performance against specific clinical acceptance criteria through a study.

Therefore, the provided text does not contain the information requested regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information.

The summary states:

• "The Karl Storz Unimat Plus system is substantially equivalent to the predicate devices since the basic features and intended uses are similar."
• "The minor differences between the Karl Storz Unimat Plus 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 indicates that the regulatory clearance is based on comparison to legally marketed devices, implying that if the predicate devices are safe and effective, and the new device is substantially similar without raising new safety/effectiveness concerns, then the new device is also considered safe and effective for its stated use. It does not describe a performance study with specific quantitative acceptance criteria for the device itself.

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The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during gynecologic laparoscopic surgical procedures.

The Karl Storz Unimat Plus and accessories is a membrane type irrigation/aspiration pump with fixed irrigation/aspiration flow rate of 3.5 liters/min. and a maximum irrigation pressure of 400 mm Hg.

The provided text describes a 510(k) summary for the Karl Storz Unimat Plus, a suction/irrigation pump. This document is a regulatory submission for a medical device that performs a physical function (suction/irrigation) and does not involve AI, image analysis, or diagnostic capabilities.

Therefore, the concepts of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of performance metrics like sensitivity, specificity, or reader studies for AI-powered devices are not applicable here.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices by ensuring that the basic features, intended uses, and safety/effectiveness are similar. It explicitly states: "The minor differences between the Karl Storz Unimat Plus 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."

To address your request directly, but acknowledging the mismatch with the provided input:

Given that this is a mechanical device, performance acceptance criteria would typically revolve around:

• Flow Rate: Achieving and maintaining the specified irrigation/aspiration flow rate.
• Pressure: Maintaining the specified maximum irrigation pressure.
• Safety: Ensuring there are no electrical hazards, leakage, or mechanical failures during operation.
• Biocompatibility: If applicable, materials in contact with body fluids must be biocompatible.
• Sterility: If applicable, sterile components meet sterility assurance levels.

A "study" to prove these would involve engineering tests, bench testing, and potentially animal or simulated use testing to confirm the device meets its design specifications and operates safely. It would not involve human experts establishing ground truth, MRMC studies, or training/test sets as would be the case for AI/diagnostic devices.

Since the provided document is a summary and not the full submission detailing the specific tests performed to demonstrate substantial equivalence for the Unimat Plus, I cannot fill out the requested table or answer the numbered questions in the context of an AI/diagnostic device. The information simply isn't present for this type of device.

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The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during general and endoscopic ENT surgical procedures.

The Karl Storz Unimat Plus and accessories is a membrane type irrigation pump with fixed irrigation/aspiration flow rate of 3.5 liters/min. and a maximum irrigation pressure of 400 mm Hg.

The provided text describes a 510(k) summary for the Karl Storz Unimat Plus, a suction/irrigation pump. This document focuses on establishing substantial equivalence to predicate devices and does not contain the detailed performance study information typically associated with AI/ML-driven medical devices that would have acceptance criteria and a structured study demonstrating its fulfillment. The device is a "membrane type irrigation pump" and not an AI/ML diagnostic tool.

Therefore, I cannot provide the requested information as it is not present in the given text. The provided text does not contain:

1. A table of acceptance criteria and reported device performance: The document states "The minor differences between the Karl Storz Unimat Plus 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 is a claim of equivalence, not a presentation of performance data against specific acceptance criteria.
2. Sample size used for the test set and data provenance: No test set is mentioned.
3. Number of experts used to establish ground truth and their qualifications: No ground truth establishment process is mentioned.
4. Adjudication method for the test set: No test set or adjudication process is mentioned.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This is not relevant for a mechanical pump.
6. Standalone (algorithm only) performance: This device is a pump, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The 510(k) summary for the Karl Storz Unimat Plus focuses on establishing substantial equivalence by comparing its basic features and intended use to predicate devices, asserting that any minor differences do not raise new safety or effectiveness concerns. It does not detail specific performance studies with acceptance criteria in the manner requested, which is more typical for software or AI/ML-based diagnostic devices.

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