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BrightMatter Navigation System 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 intra-operative guidance where a reference to a rigid anatomical structure can be identified.

The subject device, BrightMatter Navigation 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
• Preparing and executing point-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

Key functional components of the subject device 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.

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.

Here's a breakdown of the acceptance criteria and study information for the BrightMatter Navigation System v1.0, based on the provided FDA 510(k) document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a number of "samples" in a traditional clinical sense. The accuracy testing was conducted using a "measurement phantom" that mimicked brain volume.
• Data Provenance: The document does not specify the country of origin for the phantom data. The study was a non-clinical study, primarily involving engineering and system performance testing.

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

• Number of Experts: Not applicable. The ground truth for the accuracy testing was established using a Coordinate Measurement Machine (CMM), which is a precision metrology instrument, not human experts.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth was established by CMM measurements, not human consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted.
• Effect Size: Not applicable. The device is a navigation system for surgical guidance, not an AI diagnostic tool primarily evaluated by human reader performance on a diagnostic task.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Yes, the described accuracy testing (positional and angular error) is a form of standalone performance evaluation for the tracking and guidance algorithm. It assesses the device's inherent measurement capabilities without direct surgeon interaction in the measurement process (though it simulates surgical workflow via CT images of the phantom).

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the accuracy testing was established by Coordinate Measurement Machine (CMM) measurements on a measurement phantom. This provides high-precision physical measurements. In addition, for biocompatibility testing, established laboratory standards and measurement techniques were used to determine results.

8. The Sample Size for the Training Set

• Sample Size for Training Set: The document does not provide information about a "training set" in the context of an AI/machine learning model. The BrightMatter Navigation System is described as using an "optical tracking sub-system" and software for guidance. It's not explicitly stated to be an AI/ML device in the sense of requiring a large training dataset for model development. The software development follows a standard Software Development Life Cycle.

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

• Ground Truth for Training Set: Not applicable, as there's no explicit mention of a training set or AI/ML model training in the conventional sense. The "training" of such a system would typically involve calibrating the optical tracking hardware and validating the software algorithms against known physical parameters, where the "ground truth" would be the precisely known physical dimensions and positions.

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