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neuroinspire is a stereotactic software application intended to allow trained clinicians to plan surgical trajectories for neurological procedures. neuroinspire a stereotactic region for this planning based on fiducial markers in CT images. neuroinspire reports specific surgical trajectories intended to be manually set on head frame systems validated for use with neuroinspire has been validated with the Leksell Stereotactic System Type G (comprising of head ring, head frame and CT Localizer). No other components of the Leksell Stereotactic System should be used. No other stereotactic system should be used. The user should consult Section 1.7 Accuracy of these Instructions for Use to assess if the accuracy of neuroinspire is suitable for their needs.

neuroinspire surgical planning software is an application that enables the viewing of medical images to support the image based neurosurgery. It may be used by neurosurgeons to reconstruct and display multiple image sets to facilitate 2D and 3D targeting and trajectory planning in relation to an intended neurological surgical procedure. It allows the neurosurgeon to download and integrate MRI and CT DICOM (digital imaging communication) images of a patient's brain onto a PC-based platform. The neurosurgeon can then virtually slice the brain into sections, zoom in for close-ups and rotate images in order to visualize and analyze the patient's brain prior to surgery.

neuroinspire has been validated with the Leksell Stereotactic System Type G (comprising of head ring, head frame and CT Localizer).

neuroinspire surgical planning software allows a neurosurgeon to:

• . load data acquired from an MRI scanner
• . load data acquired from a CT scanner;
• manually reconstruct target anatomy using multi-planer views; .
• calculate target coordinates;
• plan trajectories; ●
• print a surgical plan.

The information provided describes the acceptance criteria and the study conducted for the 'neuro | inspire' device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document does not explicitly state the number of trajectories or target points tested for verification. It mentions "a number of representative brain targets" within a CT phantom.
• Data Provenance: The data was generated through nonclinical testing using a CT phantom. Therefore, it is not from a specific country of origin, and it is prospective in nature as it was generated specifically for this study.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• The document states that "A ground truth measurement of a CT phantom mimicking a human skull and containing a number of representative brain targets was established using a portable CMM system."
• It does not specify the number of experts, their qualifications, or if any experts were involved in establishing this instrument-based ground truth. The ground truth appears to be derived from precise measurements using a Coordinate Measuring Machine (CMM) system.

4. Adjudication Method for Test Set

• The document does not describe any adjudication method. Given that the ground truth was established using a CMM system, an adjudication process involving human experts would likely not be relevant for this type of objective measurement.

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

• No MRMC comparative effectiveness study was done. The document explicitly states "No clinical data has been submitted." Human factors studies were conducted to validate user experience, but these are distinct from comparative effectiveness studies evaluating reader performance.

6. Standalone Performance Study

• Yes, a standalone (algorithm only without human-in-the-loop performance) study was conducted. The performance data presented (positional and angular accuracy) directly reflects the device's ability to transfer trajectory information from its software plan to the Leksell stereotactic system, a process that relies on the device's calculations and measurement outputs.

7. Type of Ground Truth Used

• The ground truth used was instrument-based physical measurements. It was established by "a ground truth measurement of a CT phantom mimicking a human skull and containing a number of representative brain targets... using a portable CMM system." This is a precise physical measurement rather than expert consensus, pathology, or outcomes data.

8. Sample Size for Training Set

• The document provides no information regarding a specific training set size. The device is a "stereotactic software application intended to allow trained clinicians to plan surgical trajectories for neurological procedures." It is not described as an AI/ML algorithm that requires a traditional training set in the context of learned tasks. Instead, it is a calculation and planning tool.

9. How Ground Truth for Training Set Was Established

• As the device is a planning software and not a machine learning model requiring a training set with labeled ground truth in the conventional sense, this information is not applicable and hence not provided in the document. The software's development would have involved verification and validation against known mathematical and physical principles, rather than learning from a labeled training dataset.

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