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The Integra Camino ICP Monitor is indicated for use by qualified neurosurgeons or neurointensivists for measurement of intracranial pressure and temperature.

The Integra® Camino® ICP Monitor is a compact, portable device that provides tools for continuously determining and monitoring intracranial pressure (ICP) and intracranial temperature (ICT) directly in the brain, depending on which catheters are connected to the system. This monitor supports Integra fiberoptic and strain gauge catheters.

The Integra Camino ICP Monitor displays both ICP and temperature in numeric format. The device also displays real-time ICP waveform data. It will store the mean ICP trend data from the most recent 5 days. The user can elect to extract the ICP trend data stored on the Monitor to an external memory device or stream the data to a compatible PC via the USB output. The device also provides analog output for display on compatible bedside monitors.

The Integra™ Camino® ICP Monitor is a device designed to continuously determine and monitor intracranial pressure (ICP) and intracranial temperature (ICT)
directly in the brain.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The provided document states that "All necessary testing has been completed for the Integra Camino ICP Monitor and the test results support the conclusion that all Design Inputs (requirements and specifications) have been met." Specific numerical acceptance criteria were not detailed in the provided text, so the table reflects the implied success of meeting undefined requirements.

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

   • Sample Size: Not specified in the provided text. The document mentions "production equivalent units," but the number of units used for testing is not disclosed.
   • Data Provenance: The study was conducted by Integra LifeSciences Corporation as part of their 510(k) submission. The context strongly suggests this was a prospective series of tests conducted on the device itself, rather than analyzing existing patient data. There is no mention of country of origin for specific data, as the tests were directly on the device's functional characteristics.

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

   • This document describes non-clinical performance testing of a medical device, not a study evaluating diagnostic accuracy based on expert interpretation. Therefore, there is no mention of "experts" being used to establish a ground truth in the traditional sense (e.g., radiologists interpreting images). The ground truth for functional tests (like accuracy) would be established by validated test equipment and calibration standards.

4. Adjudication Method for the Test Set:

   • Not applicable. The described testing is non-clinical performance testing of a device's functions against design inputs, not an evaluation of subjective outputs requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC comparative effectiveness study was not done. This submission focuses on the technical performance and substantial equivalence of the device, not on comparing human reader performance with and without AI assistance. The device in question is an ICP monitor, not an AI-powered diagnostic tool.

6. If a Standalone Performance Study Was Done:

   • Yes, a standalone performance study was done in the sense that the Integra™ Camino® ICP Monitor was tested by itself to ensure it met its performance specifications. The tests listed (ICP Accuracy, Temperature Accuracy, Alarm settings, Trend functionality, Data Export, etc.) were direct evaluations of the device's own capabilities, without human interaction being an integral part of measuring its primary performance metrics (e.g., accuracy of ICP/ICT readings).

7. The Type of Ground Truth Used:

   • For tests like "ICP Accuracy" and "Temperature Accuracy," the ground truth would have been established using calibrated reference standards and measurement equipment. For other functional tests (e.g., "Alarm setting," "Data Export"), the ground truth would be predetermined specifications or expected behaviors as defined in the device's design inputs.

8. The Sample Size for the Training Set:

   • Not applicable. This is a non-clinical device performance study, not a machine learning model development. Therefore, there is no concept of a "training set" in the context of this submission.

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

   • Not applicable, as there was no training set.

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