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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 the IRRAflow Active Fluid Exchange 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® Active Fluid Exchange System (formerly branded as the CNS System) is an intracranial pressure (ICP) monitoring and drainage system, substantially equivalent to the predicate 510(k) K200807. Changes described herein were evaluated using design controls. 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. A drainage bag is attached to the Control Unit, using the Laser Leveler for defining the height of the bag 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 aspiration port.

The provided text is a 510(k) summary for the IRRAflow® Active Fluid Exchange System (AFES). It details the device's technical specifications and compares it to predicate devices to demonstrate substantial equivalence. However, it does not contain the information requested regarding acceptance criteria and performance data for an AI/ML powered device.

The document explicitly states that the device is an "intracranial pressure (ICP) monitoring and drainage system" and that "Changes made only to the Control Unit software required additional testing, including verification and validation of new and enhanced functionality." It refers to "Control Unit 4.0," which includes software enhancements.

Despite mentioning "User software enhancements" and "pressure accuracy improvement," the document focuses on engineering verification and validation tests for a hardware/software medical device, not an AI/ML algorithm. The tests listed in "Table 4" (Verification by Inspection, BSM Requirements Verification, Electrical Requirements Verification, Mechanical Performance Verification, Life Cycle Verification Test, Packaging Verification) are standard for medical device hardware and software, but do not align with the typical criteria and studies for proving the performance of an AI/ML-powered algorithm, especially none that would require ground truth from experts, multi-reader studies, or specific AI acceptance metrics like sensitivity/specificity or AUC.

Therefore, I cannot fulfill the request for a table of AI acceptance criteria and performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these details are not present in the provided document. The document describes a conventional medical device clearance, not an AI/ML clearance.

Without further information that explicitly details a clinical study demonstrating the performance of an AI/ML component with human-in-the-loop or standalone, I cannot generate the requested output.

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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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