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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 (in Ventricular mode) or regulation of drainage (in Lumbar mode) 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, 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 for greater mobility (via a battery backup) and also alert hospital staff if the ICP and/or drainage values exceed the set maximum or minimum levels for a particular patient.

The modifications included under this Special 510(k) include the following:

• Changed the Low Drain Alarm reactivation from 10 minutes to 60 minutes in the Ventricular Mode when the SED Cartridge has been confirmed to be properly primed
• Added user prompts to the User Interface Screen to provide a user check that the drain tubing path within the SED Cartridge is properly primed prior to use

The Aqueduct Critical Care, Inc. Smart External Drain (SED) System, as described in the provided document, does not contain information about specific acceptance criteria, device performance, or a study proving its performance against acceptance criteria.

The document is a 510(k) Pre-Market Notification from the FDA, which primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, rather than providing detailed clinical trial results or performance metrics against defined acceptance criteria.

The submission is specifically a Special 510(k), indicating that the modifications to the device do not affect the intended use or the fundamental scientific technology. The modifications are minor:

• Changed the Low Drain Alarm reactivation from 10 minutes to 60 minutes in the Ventricular Mode when the SED Cartridge has been confirmed to be properly primed.
• Added user prompts to the User Interface Screen to provide a user check that the drain tubing path within the SED Cartridge is properly primed prior to use.

Given these minor modifications, the submission emphasizes that the technological and performance characteristics of the modified SED System are comparable to the predicate SED System. The "Testing Summary" section mentions "Software Verification and Validation" as the testing activities performed to demonstrate intended device performance and support substantial equivalence.

Therefore, the requested information elements (acceptance criteria table, sample sizes, expert details, MRMC study, standalone performance, ground truth types, training set size, and training set ground truth establishment) are not present in this document, as they are typically found in clinical study reports or detailed design validation outputs, which are not usually fully disclosed in a 510(k) summary. The 510(k) process for a minor modification like this primarily relies on demonstrating that the changes do not introduce new questions of safety or effectiveness and that the modified device remains substantially equivalent to its predicate.

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