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The ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. During planning, the system is intended to provide functionality for the automatic identification, labeling, visualization and quantification of segmentable brain structures from a set of loaded MR images. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode including deep brain stimulation (DBS) lead placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR conditional implants and devices.

The updated ClearPoint Software Version 2.2 integrates the ClearPoint Neuro Maestro Brain Model software (K213645) into the previous ClearPoint Software Version 2.1 (K222519). The ClearPoint Maestro™ Brain Model product is a stand-alone software application for automatic labeling, visualization, and quantification of segmentable brain structures from a set of MRI images and has been incorporated into the ClearPoint System software. The ClearPoint System described in this submission is essentially identical from a technological standpoint to the cleared predicate device described in K222519 (ClearPoint System). As mentioned above, since the prior clearance, the company has integrated the Maestro Brain Model into the software of the predicate device. Specifically, the company has released an updated version of software 2.1, which was part of the last clearance, and has now been upgraded to software 2.2.

The ClearPoint System is comprised of a workstation laptop with software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ MRI-Guided Trajectory Frame, the SMARTFrame™ Accessory Kit and the SMARTFrame™ Thumbwheel Extension. The SMARTGrid and associated Marking Tool are designed to assist the physician to precisely position the entry hole as called out in the trajectory planning software. The SMARTFrame is an Adjustable Trajectory Frame (ATF) that provides the guidance and fixation for neurosurgical tools. The MRI visible fluids of the Targeting Cannula along with the fiducial markers in the base of the frame allow for trajectory feedback when the physician views the MRI images, makes changes and confirms with subsequent MR images.

The ClearPoint System can be used with any MRI-compatible head fixation frame to immobilize the patient's head with respect to the scanner table, as well as with any imaging coil(s) (supplied by scanner manufacturers) that meet the physician's desired imaging quality. ClearPoint Neuro also supplies an optional head fixation frame that can be used with the ClearPoint System.

The ClearPoint Workstation includes the following:

1. ClearPoint Workstation Software (for trajectory planning and monitoring)
2. Laptop Computer

The hardware components of the current ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile and include the following:

1. SMARTGrid MRI Planning Grid (interacts with the software to determine the desired location of the burr hole)
   a. Marking Grid
   b. Marking Tool
2. SMARTFrame Pack (SMARTFrame or SMARTFrame XG)
   a. SMARTFrame ("ATF") with Base
   b. Centering Device and Wharen Centering Guide
   c. Dock
   d. Device Lock (2 different diameters)
   e. Screwdriver
   f. Roll Lock Screw and Washer
3. Rescue Screws (Extra Titanium Screws)
4. Thumbwheel Extension
5. Accessory Kit
   a. Peel-away Sheath
   b. Stylet
   c. Lancet
   d. Depth Stop
   e. Ruler
6. Scalp Mount Base
7. Guide Tubes and Device Guide Packs (Guide Cannulas)

In addition, the ClearPoint System is used with the following separately cleared or Class I, 510(k)-exempt products:
SmartTip MRI Hand Drill and Drill Bit Kit
MRI Neuro Procedure Drape, with Marker Pen and Cover
SmartFrame MR Fiducial

Each of the above packs is sold separately and is intended to be used with the ClearPoint Workstation. Each of the components has been described in detail in previous submissions. The ClearPoint System described in this 510(k) is a modification to the company's cleared ClearPoint System (K222519).

The provide document primarily focuses on the substantial equivalence of the ClearPoint System (Software Version 2.2) to its predicate device (ClearPoint System Software Version 2.1) and the integration of functionalities from another cleared device (ClearPoint Maestro Brain Model K213645). While it mentions "Accuracy testing" and "acceptance criteria," the level of detail provided is insufficient to fully answer all aspects of your request, particularly regarding specific performance metrics for the integrated Maestro Brain Model functionalities, the study design for establishing ground truth, or details of multi-reader studies.

However, based on the information provided, here's what can be extracted and inferred:

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

The document mentions "Accuracy testing was performed to confirm that modifications included in ClearPoint System 2.2 did not cause any unexpected changes in the accuracy specifications of the software, with successful results." The Table 2, "ClearPoint System Accuracy Specifications," appears to represent the device's demonstrated performance against an underlying (but unstated) acceptance criterion for accuracy.

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

The document does not explicitly state the sample size used for "Accuracy testing" or for the validation of the Maestro Brain Model functionalities. It broadly states "ClearPoint Neuro performed extensive Non-Clinical Verification Testing." No information on data provenance (country of origin, retrospective/prospective) is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide details on the number or qualifications of experts used to establish ground truth for the test set. It mentions "Workflow for verifying the brain structure segmentation results" for the Maestro Brain Model functionality, which implies a human review process, but no specifics are given.

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

The document does not specify any adjudication method used for the test set.

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

The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the integration of an existing cleared software and ensuring the overall system's accuracy specifications are maintained. The AI component (automatic segmentation of brain structures) is integrated, but its comparative effectiveness with human readers is not detailed.

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

Yes, a standalone validation of the "Maestro Brain Model" functionality was likely already done as part of its original 510(k) clearance (K213645). The current submission states, "The inclusion of the Maestro Brain Model functionalities incorporates the functions of a standalone software product that has previously been subject of a cleared 510(k), (K213645)."

While the specific standalone performance metrics for K213645 are not reproduced in this document, the fact that it was a "stand-alone software application for automatic labeling, visualization, and quantification of segmentable brain structures" implies that its performance as an algorithm-only component was evaluated during its initial clearance.

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

The document does not explicitly state the type of ground truth used. For "Accuracy testing" related to positional and angular error, it typically involves phantom studies or precisely measured landmarks. For the brain structure segmentation, the "Maestro Brain Model" clearance (K213645) would have established its own ground truth, likely involving expert-drawn segmentations or anatomical atlases. The current submission only refers to the pre-existing clearance.

8. The sample size for the training set

The document does not provide any information regarding the sample size for the training set for any of the software's components, including the Maestro Brain Model.

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

The document does not provide any information on how the ground truth for the training set was established. This information would typically be part of the original 510(k) submission for the Maestro Brain Model (K213645), which is referenced as a predicate, but not detailed here.

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