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The use of IRRAflow Active Fluid Exchange System is 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® Active Fluid Exchange System (AFES) is an intracranial pressure (ICP) monitoring and drainage system intended for use by professional medical hospital personnel, trained and experienced in neurosurgical medical care. 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. The IRRAflow Drainage Collection System is attached to the Control Unit, using the Laser Leveler for defining the height of the Drainage Collection System relative to the catheter's tip position in the patient's head. This positioning is used for 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 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 Drainage Collection System.

The provided text is a 510(k) premarket notification decision letter from the FDA regarding the IRRAflow Active Fluid Exchange System (AFES). The purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, specifically regarding changes to the Tube Set and Drainage Collection System. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating that the modified device's performance is equivalent to, or better than, the predicate device.

Here's an analysis based on the provided document:

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

The document does not explicitly present a table of quantitative acceptance criteria alongside numerical performance results for the device. Instead, it relies on a "PASS" or "FAIL" outcome for various verification and validation tests. The acceptance criteria for these tests are implied to be established by the test protocols and industry standards (e.g., "Pressure accuracy per protocol," "Durability, flow and freedom from leakage per protocol").

Here's a table summarizing the tests performed and their reported outcomes:

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for any of the tests listed in Table 3.
The data provenance is not explicitly stated beyond general descriptions of the tests (e.g., "The Minimal Essential Media (MEM) Elution test," "This test was designed to evaluate the allergenic potential"). There is no mention of country of origin or whether the tests were retrospective or prospective. Given the nature of these tests (bench, electrical, biocompatibility, sterilization validation), they are typically conducted as prospective laboratory studies rather than clinical studies using patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The tests performed are primarily engineering and laboratory-based, often following standardized protocols. Therefore, the concept of "ground truth" established by clinical experts (like radiologists for imaging devices) would not directly apply to these types of performance tests. The "ground truth" here is implied by adherence to established test methods and acceptable performance limits defined by those methods.

4. Adjudication method for the test set

This information is not provided and is generally not applicable to the types of performance tests described (biocompatibility, electrical, mechanical, shelf life, sterilization). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and a consensus is needed to establish a definitive ground truth.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The device is a physical system for fluid exchange and pressure monitoring, not an AI-powered diagnostic tool for image interpretation or similar tasks that would typically involve human readers and AI assistance.

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

This question is not applicable as the IRRAflow AFES is a medical device for intracranial pressure monitoring and fluid drainage, not an algorithm or AI system. Its performance is evaluated through engineering and biological safety tests.

7. The type of ground truth used

For the performance tests described (biocompatibility, electrical, mechanical, shelf life, sterilization), the "ground truth" is based on:

• Established Test Standards and Protocols: Such as ASTM D4332-14, ASTM D4169-22 Cycle 13, ASTM F1886-16, ASTM F2096-11, EN 868-5:2009.
• Defined Acceptance Criteria: These criteria are inherent to the test methods and are designed to ensure safety and effectiveness (e.g., pressure accuracy per protocol, freedom from leakage per protocol).
• Laboratory Measurements and Observations: The results are direct measurements or observations within controlled laboratory environments.

It's not "expert consensus," "pathology," or "outcomes data" in the clinical sense, but rather adherence to predefined engineering and biological safety specifications.

8. The sample size for the training set

This question is not applicable because the IRRAflow AFES is a hardware medical device with specific Tube Set and Drainage Collection System modifications, not a machine learning or AI model that requires a "training set."

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

This question is not applicable as there is no training set for this device.

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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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