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The ICP Monitor is intended for use as an interface between compatible strain gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor.

The CereLink ICP Extension Cable is intended for use as a connecting cable between the ICP input channel of the CereLink ICP Monitor and a CereLink ICP Sensor.

The CereLink ICP Monitor is intended for use in the ICU or OR environment for monitoring intracranial pressure (ICP) via a solid state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions:

• Displays mean pressure values
• Displays the pressure waveform
• Displays the historic mean pressure as a trend
• Displays trend statistics (Area Under the Curve (AUC), time above threshold, boxplot, histogram)
• Stores 14-days' worth of mean ICP values
• Stores 24 hours of pressure waveform
• Can capture and store screen-shots
• Can download various data to a USB device for printing or analysis

The CereLink ICP Monitor can be transported with the patient within the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is sold with an external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted ICP sensor. The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable (code 82-6845).

The CereLink ICP Monitor and CereLink ICP Extension Cable are intended to be used in conjunction with Codman's other neuromonitoring devices: the CereLink ICP Sensor Kits (codes 82-6850, 82-6851, 82-6852, and 82-6854 cleared via K173192) and the patient monitor interface cables (codes 82-6880, 82-6881, and 82-6882 cleared via K152670). The CereLink ICP Sensor converts the patients intracranial pressure to a voltage signal. The monitor provides power to the sensor, interprets the voltage signal from the sensor, and displays the corresponding pressure measurements taken by the sensor during a patient's treatment and during patient transport. There is no change to the currently marketed CereLink ICP Sensor Kits or the patient monitor interface cables as a result of the monitor modifications described in this submission.

The CereLink ICP Monitor is an intracranial pressure monitoring system. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various performance benchmarks the CereLink ICP Monitor was tested against. The "Reported device performance" uniformly indicates that all tests passed, demonstrating "substantial equivalence of the proposed device" or that the results were "All results passed."

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

The document does not explicitly state the specific sample sizes for each test set in the bench testing section beyond noting that for "Device Reliability and Mean Time Between Failure Calculation," no samples were required for execution of this test (analysis was based on materials and components).

For other bench tests, phrases like "All results passed" or "Testing was performed on final finished devices" imply that a sufficient number of devices were tested to validate the claims, but the exact count is not specified. The studies were likely internal verification and validation tests performed by the manufacturer on production-equivalent devices.

The provenance of this data is internal to Integra LifeSciences Corp. and is presented as part of their 510(k) submission. Therefore, it is retrospective in the sense that it was conducted prior to submission for regulatory clearance. There is no information regarding the country of origin of the data provided beyond the manufacturer's location (Mansfield, MA, USA).

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

N/A. This information is typically relevant for studies involving subjective interpretation (e.g., medical imaging diagnostics). For the CereLink ICP Monitor, the performance criteria are objective (e.g., electrical specifications, mechanical integrity, software functionality, physical measurements). The "Summative Usability Testing" involved clinicians, implying professional users, but it does not specify their number or qualifications, nor was their input used to establish "ground truth" in the diagnostic sense, but rather to assess usability and effectiveness of operation.

4. Adjudication Method for the Test Set

N/A. As the testing primarily involved objective performance metrics (electrical, mechanical, software functionality), an adjudication method (like 2+1 or 3+1 often used in clinical trials for diagnostic agreement) was not applicable. Test results were likely pass/fail based on predetermined quantitative criteria.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or conducted. The device is an objective monitoring device, not a diagnostic tool requiring human interpretation with or without AI assistance. The submission focuses on demonstrating substantial equivalence to a predicate device through objective performance testing.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

The device's core function is to monitor and display ICP. Its performance is inherently standalone in the sense that its measurements are objective and do not require human interpretation to generate the primary output (ICP values, waveforms, trends). The "algorithm" here refers to the internal processing of the sensor's voltage signal to display pressure measurements. The various "Bench Testing" and "Software Testing" categories evaluate this standalone performance. For example, "Electrical Performance Testing" and "System Validation Testing" directly assess how accurately the device measures and displays pressure from a sensor or simulator without human intervention affecting the measurement generation itself.

7. Type of Ground Truth Used

The ground truth for the performance tests was based on known physical or electrical standards and predefined functional requirements. For example:

• Pressure Accuracy: Likely tested against calibrated pressure simulators or reference devices with known pressure outputs. The acceptance criteria for input pressure accuracy are given as "+/- 0.5 mmHg over the range -50 to 50 mmHg and +/- 1% over the range 50 to 150 mmHg."
• Electrical Specifications: Tested against known voltage and current standards, expected battery life, and data storage capacity.
• Mechanical Integrity: Tested against engineering specifications for durability, drop resistance, and ingress protection.
• Software Functionality: Tested against software requirements specifications to ensure features operate as intended.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning. The CereLink ICP Monitor is an objective measurement device, not an AI/ML-driven diagnostic or predictive algorithm that typically requires large training datasets. Its functionality is based on established engineering principles and signal processing.

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

N/A. As there is no "training set" in the machine learning sense, the method for establishing its ground truth is not applicable. The device's operation is deterministic based on its hardware and firmware design.

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