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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 indicated for use in the ICU or Operating Room (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 ICP Waveform
• Displays Mean ICP numeric
• Displays the historic mean pressure as a trend
• Displays trend statistics (Pressure Time Dosage (PTD), 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
• Real-time data streaming of mean ICP and waveform via USB connection
• Connect to external patient monitor

The CereLink ICP Monitor can be transported with 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 provided to the user with a CereLink ICP Extension Cable, 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 CereLink ICP sensor. The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable; the CereLink ICP Monitor connects to compatible patient monitors through the patient monitor interface cables.

The provided text describes a 510(k) premarket notification for a medical device, the CereLink ICP Monitor and CereLink ICP Extension Cable, which are intended for intracranial pressure monitoring. The document outlines acceptance criteria and performance testing for these devices, particularly focusing on modifications made to the extension cable.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document refers to "the CereLink Systems" being exposed to the electrical stress setup. It does not provide a specific number for the sample size (e.g., number of devices or test units) used in these tests.
The data provenance is from bench testing as explicitly stated ("Performance Bench Test Results"). This indicates controlled laboratory conditions. There is no mention of country of origin for the data, and the nature of the tests (bench) makes the retrospective/prospective distinction less relevant in the typical clinical study sense. However, the tests are for design verification and validation, implying they were conducted prospectively to assess the new design.

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

Not applicable. This submission pertains to a hardware device (ICP monitor and cable) and its electrical and mechanical performance, not an AI/software device that requires human expert review to establish ground truth for image or diagnostic interpretation. The testing relies on established engineering and medical device standards.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this is not an AI/software device requiring subjective interpretation or adjudication by experts. The tests are objective performance evaluations against specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The device is a hardware ICP monitor and cable, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This is not an algorithm-based device. The "performance" refers to the physical and electrical characteristics of the monitor and cable. The tests described (ICP Drift, Out-of-Range Failure, Electrical Safety, etc.) are essentially "standalone" performance evaluations of the device itself.

7. The Type of Ground Truth Used:

The ground truth for the device's performance is based on engineering specifications and internationally recognized standards (e.g., ISO, IEC). For the specific "Out-of-Range Failure Test," the ground truth for "failure" is when the device enters the out-of-range state, and the "recovery" is when it exits that state within a specified time, which are objective, measurable outcomes in a controlled "electrical stress setup" designed to reproduce these failures.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as there is no training set for this hardware device.

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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 Monitor is indicated 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 ICP Waveform .
• Displays Mean ICP numeric .
• Displays the historic mean pressure as a trend .
• Displays trend statistics (Pressure Time Dosage (PTD) , 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 9
• . Can download various data to a USB device for printing or analysis
• Real-time data streaming of mean ICP and waveform via USB connection .
• Connect to external patient monitor .

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 provided to the user with an CereLink ICP extension cable, 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 CereLink ICP sensor (cleared via K173192). The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable (cleared via K183406); the CereLink ICP Monitor connects to compatible patient monitors through the patient monitor interface cables (cleared via K152670).

Let's break down the information provided to answer your request.

Based on the provided document, the CereLink ICP Monitor is a device that interfaces with pressure transducers and monitors intracranial pressure. The submission to the FDA (K210993) is for modifications to an existing CereLink ICP Monitor (predicate K183406), not for a brand new device. Therefore, the "study" described is primarily focused on demonstrating that the modifications do not negatively impact the device's safety and effectiveness compared to the original, already cleared device.

Here's the breakdown of acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Since this is a submission for modifications to an already cleared device, the "acceptance criteria" are implied to be the successful demonstration that the modifications do not introduce new safety or effectiveness concerns and that the device continues to perform as intended and substantially equivalent to its predicate. The document doesn't list specific quantitative acceptance criteria for clinical performance in the way one might expect for a novel diagnostic algorithm. Instead, it focuses on various engineering and design-related tests to confirm the changes are benign or improvements.

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a device like the CereLink ICP Monitor, which is a physiological measurement and monitoring device, the "test set" and "ground truth" are interpreted differently than for, say, an AI-powered diagnostic imaging tool.

• Test Set/Sample Size: The document refers to various bench tests including "ICP Drift Test," "Common Mode Noise and Leakage Current Power Supply Test," "13 Day Simulated Environment Validation Test," etc. These are engineering validation tests, not clinical studies with patient data in the traditional sense of a "test set." The sample sizes would refer to the number of devices or components tested, but this specific detail is not provided in a summarized form.
• Data Provenance: Not applicable in the context of clinical data for performance validation. The testing seems to be internal engineering verification and validation.
• Experts/Ground Truth/Adjudication Method/MRMC/Standalone Performance: These concepts are largely not applicable here. The CereLink ICP Monitor is not an AI-driven diagnostic device that relies on expert interpretation or establishing a ground truth for diagnostic accuracy (like identifying a lesion on an image). It's a device that measures and displays physiological parameters. The "ground truth" in this context would be the actual physical/electrical properties that the device is designed to measure and the expected behavior under various conditions (e.g., drift, noise, safety limits). The study's focus is on validating the device's performance against these engineering and safety standards, not on its diagnostic accuracy based on expert consensus.

The document explicitly states:

• "No clinical studies were required."
• "Appropriate verification of the subject device was achieved based on the comparison to the predicate device and from the results of the bench, software, electrical safety, and electromagnetic compatibility testing."
• "The CereLink ICP Monitor is a reusable, non-sterile device. There is no expiry date and shelf-life is not applicable for this device."
• "The CereLink ICP Monitor is non-patient contacting. Therefore, biocompatibility is not applicable for this device."
• "No animal studies were required."

This indicates that the "study" primarily consisted of bench testing and engineering verification and validation to confirm that the technical modifications (power supply, internal components, software updates, etc.) did not compromise the device's ability to accurately measure ICP, maintain electrical safety, and function reliably.

8. The sample size for the training set
9. How the ground truth for the training set was established

These questions are not applicable as the CereLink ICP Monitor is not described as an AI/machine learning device that requires a training set. The modifications described are hardware and software updates to an existing physiological monitoring device, not the development of a predictive algorithm using a "training set."

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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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