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The use of IRRAflow CNS System is indicated when intracranial pressure monitoring is required and for externally draining intracranial fluid as a means of reducing intracranial pressure in patients where an external drainage and monitoring system is needed for ≤ 24 hours.

The IRRAflow® CNS System is an intracranial pressure (ICP) monitoring and drainage system. The IRRAflow CNS System consists of an IRRAflow Control Unit and two sterile disposable parts, the IRRAflow Tube Set and the IRRAflow Catheter.

The drainage flow of cerebrospinal fluid (CSF) into the IRRAflow Catheter is uni-directional and gravity-driven; there is no recirculation of the CSF. A parallel line from the saline infusion bag is used in case clearance at the tip of the catheter is required. The IRRAflow Tube Set has a cassette that clicks on to the IRRAflow Control Unit and aligns the tubing against a peristaltic pump and pinch valve. An aspiration bag is attached to the Control Unit tape measure, defining the height of the bag relative to the catheter's tip position in the patient's head and thus controlling the speed of drainage. The tubing and catheter can be disconnected and connected by standard Luer-Lock connectors. Settings can be changed via the user interface on the Control Unit.

The default mode provides drainage and measuring ICP, allowing single bolus injections when indicated. The bolus injections allow the catheter to be flushed when it becomes clogged. CSF or intracranial fluid samples can be taken from the aspiration port.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: IRRAflow CNS System

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a direct table of acceptance criteria with numerical targets. Instead, it details various tests performed and reports the outcome as "PASS" if the acceptance criteria for that specific test were met. The acceptance criteria for each test were implied to be compliance with documented requirements or relevant standards (e.g., ISO 10993, IEC 60601-1-2:2014).

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

The document does not specify the sample sizes used for the various tests described (e.g., number of animals for biocompatibility, number of units for bench testing).

The data provenance is not explicitly stated as country of origin or retrospective/prospective. The description suggests bench testing and laboratory studies (e.g., animal tests for biocompatibility, electrical tests), rather than studies involving human clinical data.

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

This information is not applicable as the studies described are primarily laboratory-based verification and validation tests, not studies requiring expert interpretation of clinical data to establish a ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes bench testing and laboratory validation to demonstrate substantial equivalence to predicate devices, not studies involving human readers or comparative effectiveness in a clinical context. Therefore, there's no effect size reported for human readers improving with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

The IRRAflow CNS System is a physical medical device (drainage and monitoring system), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The verification and validation described represent the standalone performance of the device itself.

7. The Type of Ground Truth Used:

The "ground truth" for the tests performed is based on:

• Standardized Biological Responses: For biocompatibility tests, the ground truth is the expected biological reaction in animal models (e.g., absence of fever, absence of toxic effects, normal cell growth, non-hemolytic properties, no irritation/sensitization) according to established international standards (like ISO 10993).
• Engineering Specifications and Requirements: For bench and electrical testing, the ground truth is defined by the device's design specifications, documented requirements, and adherence to international safety and performance standards (e.g., IEC 60601-1-2:2014) and the manufacturer's own internal validated requirements.
• Physical and Mechanical Properties: For catheter performance tests (tensile, torsion, shear, drainage flow), the ground truth is the specified physical and mechanical properties and expected performance parameters.
• Sterility Assurance Levels: For sterilization and package integrity, the ground truth is the demonstration of sterility and maintenance of a sterile barrier according to validated protocols and standards.

8. The Sample Size for the Training Set:

This information is not applicable. The IRRAflow CNS System is a hardware medical device with integrated software for control and monitoring, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" for the device would be its design and manufacturing processes, guided by engineering principles and standards.

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

This information is not applicable for the same reason as point 8.

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