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The use of the ACT II MP Monitoring System by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure in patients is required and when the patient may require CSF drainage in the course of their care or when data from a second parameter may be deemed useful in optimum patient management.

The ICP monitor uses a bolt anchored in the skull. The bolt holds an air-column catheter with a flaccid bladder on the distal end. The proximal end of the catheter is attached to a pressure transducer placed in the distal end of a standard cable. The cable can be attached directly to any patient monitor. The ICP monitoring technology is based on Boyle's law. The bladder volume changes to accommodate PTV =P2V2 The pressure in the bladder, catheter and transducer thereby mirrors that of ICP. The air required to activate the bladder is introduced into the bladder when a piston on the proximal end of the catheter is joined to a cylinder on the transducer housing. The bladder air is replaced once per shift by removing and replacing the transducer housing on the piston.

A probe guide is incorporated into the cap placed on the bolt at the factory and into the cap that accompanies the drainage catheter. The guides direct the path of a probe inserted through the cap/bolt. The guide tube does not enter the brain but stops just above the drill hole. Both caps provide a compression fitting that secures and seals the probe to the cap.

The catheter is a single lumen catheter. A preloaded stylet is used for catheter insertion and placement. A luer connector is provided to connect the catheter to a standard CSF collection system.

The bolt provides an access port through which a ventricular catheter can be introduced if drainage is needed. Should drainage of CSF be indicated, the top cap of the bolt is removed and the ACT II Ventricular Catheter is inserted into a ventricle. Once the catheter is in place, a preinstalled elastomeric sleeve and compression cap are moved down the catheter to the bolt. The cap compresses the sleeve against the bolt and catheter anchors the catheter in place.

Here's a breakdown of the acceptance criteria and study information for the ACT II MP ICP Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify a sample size for a test set or the data provenance (e.g., country of origin, retrospective/prospective) for a clinical study related to this specific modification (the MP version).

The text mentions:

• "Animal test data of the subject device vs. a ventricular catheter shows the device faithfully follows the ventricular pressure and waveform and that the bolt is securely anchored in the skull." This implies animal testing was conducted.
• "Laboratory testing has shown that the ACT II MP ICP Monitoring System... are safe in the following areas: Mechanical integrity; Biocompatibility." This refers to laboratory tests, not human clinical trials.

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

This information is not provided in the document. The study described is primarily animal and laboratory testing, not a human clinical trial where expert-established ground truth would be relevant in the same way (e.g., for diagnostic accuracy).

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the described animal and laboratory testing, an adjudication method like 2+1 or 3+1 (typically used in human reader studies for diagnostic accuracy) would not be applicable.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or described in the provided text. The device is a medical monitoring system, not an AI diagnostic tool primarily aimed at improving human reader performance.

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

This is not applicable as the device described is a physical intracranial pressure monitoring system and associated components, not a software algorithm.

7. Type of Ground Truth Used

Based on the text, the ground truth for the performance evaluation comes from:

• Physiological measurements in animal models (e.g., actual ventricular pressure and waveform).
• Laboratory test results (e.g., mechanical integrity tests, biocompatibility tests against ISO standards).
• Consensus standards (AAMI performance standards for accuracy).

8. Sample Size for the Training Set

This is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable for the same reason as above (not an AI/ML algorithm).

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