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The Camino® SPM-1 Intracranial Pressure Monitor is indicated for use when direct measurement of intracranial pressure (ICP) is clinically important.

The SPM-1 is an intracranial pressure monitor which features continuous mean Intracranial Pressure (ICP) display, high ICP alarm, and bedside monitor capabilities. The SPM-1 is a modified MPM-1 ICP monitor. It contains the same circuit boards as the MPM-1 but with fewer components, based on the scaled down features (no waveform display, temperature monitoring or ability to calculate CPP). The SPM-1 is supplied with a PAC-2 Pre-Amp Cable, and a PMIO-SPM Patient Monitor Cable. Non-sterile adapter cables (REF ICP-XX) are used to interface the PMIO-SPM cable to specific bedside monitors. These non-sterile cables come in many configurations, which facilitate data transfer between the PMIO-SPM cable and a specific brand of external bedside monitor. The following Camino® 110-4 Series ICP catheters are intended to be used with the SPM-1: 110-4B (Ventricular Bolt Pressure Monitoring Kit), 110-4G (Post Craniotomy Subdural Pressure Monitoring Kit), 110-4HM (Micro Ventricular Bolt Pressure Monitoring Kit), and 110-4L (Intracranial Pressure Monitoring Catheter with Licox® IMC Bolt Fitting). The use of temperature catheters is not recommended with the SPM-1.

The Camino® SPM-1 Intracranial Pressure Monitor, based on the provided 510(k) summary, does not detail specific acceptance criteria or a dedicated study proving its performance against such criteria in the way a modern AI/ML device submission would. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Camino® Multi-Parameter Pressure Monitor, K962928) and general safety testing.

Here's a breakdown of the requested information based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics for the SPM-1. The primary claim for performance is its substantial equivalence to the predicate device, implying it performs equivalently.

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

The document does not describe a clinical "test set" with a specific sample size for performance evaluation in the context of analytical or clinical accuracy. The testing mentioned appears to be primarily engineering verification and validation testing for safety and functionality. No information is provided regarding data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable. The device is a physical Intracranial Pressure (ICP) monitor. Its "ground truth" would be the actual ICP measurements, which are obtained directly by the device, not by expert consensus on images or other diagnostic data.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, there's no "test set" requiring adjudication of ground truth by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. The Camino® SPM-1 is a hardware device for measuring ICP, not an AI-assisted diagnostic tool or an algorithm that human readers would use to improve their interpretations. Therefore, an MRMC study and AI assistance effect size are not relevant to this device.

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

Not applicable. This is a standalone medical device in the sense that it measures ICP directly. It's not an algorithm that functions without human interaction for its primary purpose of measurement, but it also doesn't involve "human-in-the-loop performance" in the context of AI interpretation. Its performance is inherent in its measurement capabilities.

7. The Type of Ground Truth Used:

The ground truth for an Intracranial Pressure Monitor is direct measurement of intracranial pressure. This is a physiological measurement, not an expert consensus, pathology, or outcomes data in the usual diagnostic sense. The accuracy of the device's measurement would be compared against a known standard or another highly accurate measurement method (e.g., in a laboratory setting). While not explicitly stated, general performance testing for such a device would involve calibration and accuracy checks against pressure standards.

8. The Sample Size for the Training Set:

Not applicable. The Camino® SPM-1 is an electromechanical device, not a machine learning or AI model. Therefore, it does not have a "training set" in the computational sense.

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

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

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