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

• Added ICP Waveform Display to User Interface Screen.
• Software loading via USB interface.
• Optimization of the SED System's initialization sequence.

The Aqueduct Critical Care, Inc. Smart External Drain (SED) System, as described in the provided 510(k) summary, underwent testing to demonstrate its performance and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria alongside specific numerical performance results. Instead, it lists various performance tests and states that "All acceptance criteria for the test method were met" for each.

Given this, the table below is constructed based on the described tests and the consistent "PASS" outcome:

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each individual test or for the overall test set.
The data provenance is not explicitly stated beyond the tests being performed by the manufacturer, Aqueduct Critical Care, Inc. It does not mention country of origin or if the data was retrospective or prospective. Given the nature of a 510(k) submission for a modified device, these would typically be internal engineering and bench tests, not clinical studies involving patient data provenance in the same way.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the type of testing described. The tests are focused on the hardware and software performance of the medical device itself (e.g., button force, leak resistance, software functionality) through bench testing. They do not involve human interpretation of medical images or data requiring clinical expert ground truth in the traditional sense.

4. Adjudication Method for the Test Set

This information is not applicable. As the testing primarily involves objective measurements of device performance parameters against predetermined engineering specifications, an adjudication method for reconciling expert opinions is not relevant.

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 mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This product is a physical device (an external drain system) with automated features, not an AI/CADe (Computer_Assisted Detection) or AI/CADx (Computer_Assisted Diagnosis) system that would typically warrant such a study for human reader improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device is an electromechanical system with embedded software. The performance testing outlined (e.g., functionality, pressure resistance, initialization cycle, software verification) inherently represents the "standalone" performance of the algorithm and hardware working together. It's not an "algorithm-only" performance in the sense of an AI model analyzing data, but rather the system's automated functions operating independently as designed.

7. The Type of Ground Truth Used

The ground truth for the performance tests described would be the predefined engineering specifications and design requirements for the device's physical and functional characteristics. For example:

• Bond Joint Testing: Ground truth is the specified minimum tensile strength for the bond joints.
• Dimensional Verification: Ground truth is the specified weight range for the cartridge.
• Pressure Measurement Range: Ground truth is the specified accurate operating range of -5 to 40 cm H2O.
• Software Verification: Ground truth is the validated software requirements and expected outputs.

8. The Sample Size for the Training Set

This information is not applicable. This submission details a physical medical device (External Drain System) with embedded software, not an AI model that undergoes a "training" phase with a dataset. The software development process likely involved various verification and validation activities, but not "training" in the machine learning sense.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no "training set" in the context of an AI model for this device. The software development followed standard engineering and quality system processes, with ground truth established through design specifications, requirements, and testing protocols.

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