(114 days)
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.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).