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BrightMatter Guide with SurfaceTrace Registration is intended as a planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures where the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The user should consult the "Accuracy Characterization" section of the User Manual to assess if the system is suitable for their needs.

The subject device, BrightMatter Guide with SurfaceTrace Registration is a modification of the software component of BrightMatter Navigation system that is presented in K142024. The system is a planning and image guided surgical system that enables computer assisted surgery where use of stereotactic image guidance may be considered appropriate. In particular, the device is suitable for neurosurgical cranial procedures. The planning functionality of the device is provided by an already cleared device, BrightMatter Planning (K140337). The remaining system provides a sequence of discrete workflow activities (or phases) that guide a surgeon through the process of data preparation for the surgical procedure. Then the device aids the surgeon in visualizing the location of the surgical tools relative to clinical images and physical location of the patient.

Following is a summary of steps involved in data preparation and registration of the patient's head position relative to pre-surgical clinical images:

• . Importing plan and imaging data
• Reviewing and selecting a previously generated surgical plan .
• . Optionally fusing (merging or co-registering) additional imaging data
• Registering the clinical images to the patient using either Point registration or . SurfaceTrace based registration.

Following steps are provided as visualization tools during the execution of the surgical procedure:

• . Aid in visualizing location of the surgical site as planned by the surgeon (using BrightMatter Planning software, K140337)
• . For trajectory-centric procedures, help visualize insertion of tracked surgical tools by identifying location of surgical tool's position and orientation relative to clinical images and the surgical plan developed by the surgeon
• . Visualize location of tracked surgical tools after the intended target location has been reached
• . The purpose of this 510k submission is introduce a new registration methodology using changes that are limited to the software component of the previously cleared system. Key functional components of the system are an optical tracking sub-system, navigated surgical tools, custom software application and an external display. The navigated surgical tools are tracked using single-use passive reflective markers (K033621) that are attached to the surgical tools prior to each surgical procedure.

The surgical display and tracking camera are mounted on an Auxiliary Cart. The computer is housed in a Navigation Cart. These components have been cleared as part of the BrightMatter Navigation system (K142024).

As with many systems in the OR, not all components need to be sterile during use. The only subcomponents that come in contact with the patient are the Pointing Tool, Port Reference Tool and Calibration Block. These tools fit in the limited contact duration category. The tools have been cleared as part of the BrightMatter Navigation system (K142024).

Here's a breakdown of the acceptance criteria and study information for the BrightMatter Guide with SurfaceTrace Registration device, based on the provided document:

Acceptance Criteria and Device Performance

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: The document refers to an "accuracy measurement phantom of similar volume to an adult head." It does not specify a numerical sample size for individual measurements on this phantom but implies a comprehensive set of measurements taken at various locations (center and boundaries of the tracking volume).
   • Data Provenance: The study was conducted internally by Synaptive Medical Inc. in Canada (based on the submitter's address). The data is prospective in the sense that the testing was performed on the device to characterize its performance for this submission.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • The ground truth for the test set (the accuracy measurement phantom) was established using a Coordinate Measurement Machine (CMM). This implies mechanical measurement, not expert human assessment directly for the ground truth of the phantom. No human experts are explicitly mentioned as establishing the ground truth for the CMM measurements themselves.

3. Adjudication Method for the Test Set:

   • Not applicable. The ground truth for the phantom was established by a CMM, an objective mechanical measurement, not through human consensus.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The testing focused on the standalone accuracy and performance of the device's new registration method. The "Design Validation" mentions simulated use with intended users, but this is described as confirming substantial equivalence and not an MRMC study measuring reader improvement with AI assistance.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   • Yes, a standalone performance evaluation was conducted. The "Characterization of system accuracy" section directly assesses the device's ability to measure positional and angular errors using the SurfaceTrace registration method on an accuracy phantom, explicitly stating "Positional error was measured to be less than 2 mm and angular error was measured to be less than 2 degrees." This is an algorithm-only assessment of the core accuracy of the registration.

6. Type of Ground Truth Used:

   • Mechanical Measurement (CMM): The ground truth for the accuracy phantom was obtained using a Coordinate Measurement Machine (CMM).

7. Sample Size for the Training Set:

   • The document does not specify the sample size for any training set. It describes a modification to the software component of a previously cleared device and focuses on the performance characterization of the new SurfaceTrace Registration method. This submission is for a modification, and while the underlying BrightMatter Navigation system would have had development, the details of its training data are not provided here.

8. How the Ground Truth for the Training Set Was Established:

   • Since the document does not specify a training set sample size or details about a training set, it does not provide information on how its ground truth was established.

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