(62 days)
Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:
- · Reduce intracranial pressure (ICP), e.g., pre, intra- or postoperative.
- · Monitor CSF chemistry, cytology, and physiology.
- · Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
Monitoring of intracranial pressure (ICP) is indicated in selected patients with:
- · Severe head injury
- · Subarachnoid hemorrhage graded III, IV, or V preoperatively
- · Reye's syndrome or similar encephalopathies
- Hydrocephalus
- · Intracranial hemorrhage
- · Miscellaneous problems when drainage is to be used as a therapeutic maneuver
Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.
The SED System is based upon traditional gravity-based drainage systems, but is designed to allow for the automated regulation of ICP or CSF drainage volume without the need for continuous manual measurements, adjustments and interventions. The SED System consists of an electromechanical, software embedded SED Console and a sterile, disposable SED Cartridge, which includes all components necessary to attach to the external drainage catheter via a luer-lock connector and to a drainage bag that collects the drained fluid.
The SED System is mounted on an IV pole, with the SED Console positioned by the user at an easy-to-view height, while the drainage bag is positioned below the lowest possible patient head position or lumbar puncture site, which is considered to be below the height of a hospital bed.
The SED System automatically maintains a set drainage rate (for lumbar use) or set ICP (for ventricular use) using a drip counter or pressure sensors (transducers), respectively, and an automated stepper-motor pinching mechanism that compresses or releases the system's compliant drain tubing in order to control the degree of CSF flow (i.e., equivalent to the alteration of CSF flow that happens when a traditional gravity drain is manually raised or lowered). The SED System displays the measured drainage or ICP information, while additionally incorporating multiple alarms provided by its automated functionality.
The SED System can thus automatically compensate for patient movement, allow far greater mobility (via a battery backup) and also alert hospital staff if the ICP exceeds the set maximum or minimum levels for a particular patient, as well as if low or high CSF drainage values are ever exceeded for a particular lumbar patient.
The provided text is a 510(k) summary for the Aqueduct Critical Care, Inc. Smart External Drain (SED) System. It describes the device, its indications for use, and a summary of testing performed to demonstrate substantial equivalence to predicate devices.
However, the document does not contain the specific information required to answer your request about acceptance criteria and a study proving a device meets acceptance criteria, particularly in the context of an AI-powered diagnostic device. The SED system described is an electromechanical device for draining and monitoring CSF, not an AI-driven diagnostic tool. Therefore, the concepts of "expert consensus," "MRMC studies," "effect size of human readers improving with AI," "standalone algorithm performance," and "training/test set ground truth establishment" (which are typical for AI/ML medical devices) are not applicable to this submission.
The testing summarized in the document is related to the functional performance, stability, software verification, and electrical safety of the physical medical device, not the performance of an AI algorithm based on diagnostic accuracy metrics.
Therefore, I cannot extract the requested information from the provided text because it describes a different class of medical device and type of study than what your prompt implies.
If you have a document describing an AI-powered medical device and its validation studies, I would be happy to analyze it for the requested details.
§ 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).