ClearPoint System (Software Version 2.2)

The ClearPoint System (Software Version 2.2) is a neurological stereotactic instrument providing MRI-guided assistance for precise instrument placement during neurosurgical procedures like biopsies and DBS lead insertion. It leverages MR imaging and incorporates new software functionalities for automatic brain structure identification, visualization, and quantification, aiming to enhance surgical planning and execution.

The ClearPoint System (Software Version 2.2) is a neurological stereotactic instrument designed to provide guidance for the placement and operation of instruments or devices during neurological procedures conducted within an MRI environment and in conjunction with MR imaging. It is intended for use with 1.5 and 3.0 Tesla MRI scanners and MR conditional implants. The system, comprising a workstation laptop with specialized software, the SMARTGrid MRI-Guided Planning Grid, the SMARTFrame MRI-Guided Trajectory Frame, and associated accessories, facilitates procedures such as biopsies, catheter and electrode insertions, including deep brain stimulation (DBS) lead placement, by enabling precise targeting and navigation. This updated version 2.2 enhances the system's capabilities primarily through the integration of the ClearPoint Neuro Maestro Brain Model software functionalities. This integration allows for optional automatic identification, labeling, visualization, and quantification of segmentable brain structures directly from loaded MR images, aiding in detailed surgical planning. Additional software improvements include compatibility with Windows 11, enhanced DICOM image handling (including color images), user-selectable viewing orientations, flexible anatomical coordinate referencing, improved measurement tools, workflow optimizations, and support for multiple languages. Non-clinical verification and accuracy testing confirmed that these modifications maintain the system's performance, with demonstrated positional accuracy (mean errors of 0.14mm, 0.16mm, 0.56mm in X,Y,Z) and angular accuracy (mean error of 0.32°).

AI Regulatory Concerns

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• Q1. What is the typical processing time for the automatic segmentation of cortical and subcortical structures using the integrated Maestro Brain Model, and how does this integrate into the real-time surgical workflow?; How does the system's targeting accuracy (± 1.5 mm @ ≤125mm) and software positional/angular error vary with different MRI scanner field strengths (1.5T vs 3.0T) or specific imaging sequences?; Can the brain structure segmentation results be manually edited or refined by the clinician if the automated output requires adjustment, and how are these edits logged or incorporated within the system?; What specific validation studies were performed to confirm the accuracy of the volume measurements for segmented brain structures, especially in cases with anatomical abnormalities or post-surgical changes?; Beyond Windows 11 compatibility, what are the minimum hardware specifications for the laptop computer to ensure optimal performance of the ClearPoint Software Version 2.2, particularly with the new computationally intensive segmentation features?