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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.

The IRRAflow CNS System is an intracranial pressure (ICP) monitoring and drainage system. It 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. A parallel line from the saline infusion bag is used for clearance at the tip of the catheter. 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. CSF or intracranial fluid samples can be taken from the aspiration port. The submission also includes the IRRAflow® Laser Leveler, a reusable accessory to be utilized in conjunction with the IRRAflow® CNS system to assist in setting the height of the control unit by generating a laser mark.

This document describes the design verification and validation for an accessory, the IRRAflow® Laser Leveler, to an existing medical device, the IRRAflow® CNS System. The main device (IRRAflow® CNS System) itself has not undergone any changes, and therefore no new performance data was required for it. The focus of this submission is on the laser leveler accessory.

Here's the breakdown of the requested information based on the provided text:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the exact sample size for each test. It generally refers to "units" or "packages" being tested. For certain tests like "Schedule A Initial manual handling - ASTM D5276-98 Box", it mentions "Six (6)" impacts, which implies a sample size of at least one unit per test setup.
• Data Provenance:
  • Development and testing for the laser leveler was performed at a contract manufacturer, Meraqi Medical, Inc. (Freemont, CA).
  • Laser testing was performed at a sub-contractor, Intertek (Menlo Park, CA).
  • This indicates the data originates from the USA.
  • The studies mentioned are verification and validation tests performed during the design and manufacturing process of the laser leveler. These are typically prospective tests aimed at confirming product specifications and safety.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable to this submission. The laser leveler is a physical accessory designed to assist with a spatial alignment task. The tests performed are engineering-focused (dimensional, functional, safety, environmental, packaging), not clinical performance evaluations requiring expert assessment for "ground truth". The "ground truth" for these tests is defined by established engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable. As these are engineering verification and validation tests against established standards and specifications, there is no need for a human adjudication method in the context described (like consensus in image interpretation). The results are objective measurements (e.g., passing a specific temperature range, meeting a safety standard).

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

• This information is not applicable. The device (IRRAflow® CNS System with Laser Leveler) is not an AI-powered diagnostic imaging system or an AI-assisted interpretation tool. It's a medical device system for intracranial pressure monitoring and fluid drainage, with an accessory to aid in physical alignment. Therefore, an MRMC study is not relevant.

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

• This information is not applicable. The IRRAflow® CNS System and its laser leveler accessory are physical medical devices, not an algorithm. The laser leveler functions as a tool that assists a human operator in a physical setup task; it is not a standalone algorithm performing automated analysis.

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

• The ground truth for the verification and validation tests listed is based on established engineering standards, safety requirements, and design specifications. For example, for IEC 60825-1, the ground truth is "conformance to the IEC 60825-1 standard for laser safety". For dimensional tests, it's the design specification for the dimensions of the unit. For packaging tests, it's the ability to withstand specific environmental and physical stressors as defined by ASTM standards.

8. The sample size for the training set

• This information is not applicable as the IRRAflow® Laser Leveler is not an AI system that requires a training set. It is a physical device that underwent engineering verification and validation.

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

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

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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.

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.

The provided document (K192289) describes the 510(k) clearance for the IRRAflow® CNS System. This is a medical device and not an AI/ML algorithm. Therefore, many of the specific questions related to AI/ML model performance, such as MRMC studies, ground truth establishment for training data, and expert consensus for test sets, are not applicable.

However, I can extract the acceptance criteria and the claimed performance of the device based on the testing reported for this medical device.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are demonstrated by passing various bench, electrical, and biocompatibility tests. The "Results" column in Table 3 indicates the device's performance against these criteria, which is consistently "PASS."

Table of Acceptance Criteria and Reported Device Performance (Derived from Table 3):

Regarding the specific questions that are more relevant to AI/ML studies (and why they are not directly applicable here):

2. Sample sizes used for the test set and the data provenance: This device is a hardware system, not an AI/ML diagnostic. The "sample size" for testing refers to the number of units or biological samples used in bench, electrical, and biocompatibility tests. For example, biocompatibility tests might involve a certain number of rabbits or mice. The "data provenance" is not specified beyond the tests themselves (e.g., "saline extract of the test article," "dermal tissues of rabbits"). These are laboratory tests, not clinical data sets from patients. All tests listed in Table 3 were conducted to demonstrate substantial equivalence and safety/effectiveness of the device itself, not an algorithm's performance on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic algorithms, refers to a definitive diagnosis or finding. For a physical medical device like the IRRAflow® CNS System, "ground truth" is established through physical, chemical, and biological performance standards (e.g., whether a material is cytotoxic, whether a mechanical component withstands stress, whether electrical safety standards are met). These are determined by established laboratory methods and validated instrumentation, not by human expert consensus on medical images or clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, for the reasons mentioned above. Adjudication is a process for resolving discrepancies in expert interpretations of data (e.g., radiologists reviewing an image). This device's performance is measured against engineering and biological standards.

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: Not applicable. MRMC studies are used to evaluate the impact of an AI diagnostic tool on human reader performance. This device is a physical system for intracranial fluid management and pressure monitoring, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for this device's acceptance is based on adherence to established engineering standards (e.g., IEC 60601-1-2 for electromagnetic compatibility, ISO 10993 series for biocompatibility) and direct physical/chemical measurements (e.g., tensile strength, flow rates). These are objective measurements rather than interpretations of clinical data.

8. The sample size for the training set: Not applicable. There is no AI model to train.

9. How the ground truth for the training set was established: Not applicable. There is no AI model to train.

In summary, the provided document details the regulatory clearance of a physical medical device (IRRAflow® CNS System) through a 510(k) submission. The acceptance criteria and performance are demonstrated via a series of non-clinical (bench, electrical, biocompatibility, sterilization, and packaging) tests against predetermined engineering and biological standards, rather than through clinical studies involving human readers or AI algorithms.

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