(139 days)
Draining and monitoring of CSF flow from the lateral ventricles 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 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 ventricular 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, which is considered to be below the height of a hospital bed.
The SED System automatically maintains a set ICP using pressure sensors (transducers) 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 ICP information and also calculates and displays CSF flow volume output, while additionally incorporating multiple alarms given 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 ever the ICP exceeds the set maximum or minimum levels for a particular patient, as well as if low or high CSF drainage values (as also set by the user) are ever exceeded.
The provided text describes the Smart External Drain (SED) System, but it does not contain information related to an AI/ML-based device or a study involving human readers or expert consensus for establishing ground truth.
The document is a 510(k) premarket notification for a medical device (Smart External Drain System) and focuses on demonstrating substantial equivalence to a predicate device through various types of engineering, performance, and validation testing (e.g., mechanical, electrical, sterilization, biocompatibility, software verification).
Therefore, I cannot fulfill most of your request as the information is not present in the provided text. Specifically, I cannot provide:
- A table of acceptance criteria vs. reported device performance for an AI/ML system.
- Sample sizes used for test sets with data provenance in the context of an AI/ML model.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results or effect size.
- Standalone AI algorithm performance.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data) in the context of an AI/ML model.
- Sample size for a training set (as this is not an AI/ML device).
- How ground truth for a training set was established (as this is not an AI/ML device).
The document details the device's functional performance and safety, which is different from validating an AI/ML model's diagnostic or predictive capabilities.
§ 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).