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The Pressio® 2 Intracranial Pressure Monitoring system is indicated for continuous invasive monitoring of intracranial pressure by trained personnel of (neuro) intensive care units and neurosurgery departments.

Depending the type of catheter used, the Pressio® 2 ICP Monitor can also display the intracranial temperature.

According to the clinical situation, users choose the appropriate Pressio® catheters:

• Pressio® kit for monitoring intracranial parenchymal pressure and temperature with bolt (PSO-PBT) indicated for use in parenchymal pressure and temperature monitoring.

• Pressio® kit for monitoring intracranial parenchymal pressure and temperature with tunneling (PSO-PTT) indicated for use in parenchymal pressure and temperature monitoring.

• Pressio® kit for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure and temperature monitoring and cerebrospinal fluid drainage application.

The following Pressio® kits for Intracranial Pressure Monitoring are also compatible with the Pressio® 2 ICP Monitor:

• Pressio® kit for monitoring intracranial parenchymal pressure with bolt (PSO-PB) indicated for use in parenchymal pressure monitoring
• Pressio® kit for monitoring intracranial parenchymal pressure with tunneling (PSO-PT) indicated for use in parenchymal pressure monitoring.
• Pressio® kit for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application.

The Pressio® 2 ICP Monitoring System is composed of a monitor (PSO-4000) with accessories and implantable catheters. The PSO-4000 monitor is an electromedical device designed for monitoring patient's intracranial pressure and temperature via catheters implanted in parenchyma (PSO-PBT and PSO-PTT) or in ventricles with drainage of cerebrospinal fluid (PSO-VTT). Previously marketed Pressio® kits (K062584) are also available on the Pressio® 2 ICP Monitor and allows monitoring of intracranial pressure via catheters implanted in parenchyma (PSO-PB and PSO-PT) or in ventricles (PSO-VT) with also drainage of cerebrospinal fluid.

The Pressio® 2 ICP Monitor can also be connected to a patient monitor via a compatible monitor connection cable. This connection is not necessary for Pressio® 2 Intracranial Pressure Monitor functioning. The Pressio® 2 Monitor can also extract data to external computer via a USB cable. The Pressio® 2 ICP Monitoring System is sold as a kit containing a Pressio® 2 ICP Monitor (PSO-4000), a power supply cable (PSO-AC), a catheter extension cable (PSO-EC30).

The provided text is a 510(k) Premarket Notification from the FDA for the SOPHYSA SA Pressio® 2 ICP Monitoring System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for de novo approval. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, test set details, ground truth establishment, expert adjudication, MRMC studies, and training set information is not present in this document.

However, based on the non-clinical testing section and comparative tables, we can extract some information related to the device's conformance to standards, which implicitly defines some "acceptance criteria" through compliance.

Here's a breakdown of the available information:

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

The document does not provide a specific table of acceptance criteria with numerical performance targets and actual device performance results in the way one would see for a de novo submission focusing on clinical accuracy. Instead, it refers to conformance to established medical device standards as the primary means of demonstrating performance and safety, thereby implicitly defining acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document is a 510(k) submission, primarily relying on non-clinical testing (bench testing, component analysis, and conformance to standards) to demonstrate substantial equivalence, rather than new clinical trials with patient test sets. Therefore, details about a "test set" in the context of clinical data (like patient numbers, retrospective/prospective nature, or country of origin) are not included. The performance testing mentioned (e.g., "Placement in subdural space - Pressure Measurement") would refer to bench or simulated testing, not a clinical patient sample size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this is a non-clinical submission relying on engineering/bench testing and conformance to standards, not human expertise for ground truth in image interpretation or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There's no mention of a human-read test set or adjudication process.

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

Not applicable. This device is an ICP monitoring system, not an AI-assisted diagnostic tool for human readers/interpreters.

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

This refers to the device's intrinsic ability to measure ICP and temperature as designed. The entire non-clinical testing described (conformance to standards for electrical safety, EMC, software, biological evaluation, etc.) is essentially evaluation of the device's standalone performance against defined engineering and safety benchmarks. The performance claim "No alteration of pressure measured with a Pressio® catheter when inserted in a subdural space" is a direct standalone performance assessment.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is established by engineering specifications, physical measurements/calibrations, and compliance with recognized industry standards (e.g., ISO, IEC, AAMI) for medical device safety, performance, and functionality. For example, the ground truth for pressure measurement accuracy would be established by calibrated pressure sensors and established metrology.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a "training set."

9. How the ground truth for the training set was established

Not applicable.

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