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The SmartFrame OR is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of a compatible optical stereotaxic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction.

The SmartFrame OR is a hardware-only precision trajectory aiming device for procedures conducted entirely in the traditional operating room and in conjunction with commercially available optical navigation systems such as Medtronic Stealth Station S8, or functionally equivalent optical navigation systems.

The SmartFrame OR Stereotactic System tower consists of three assemblies. The reference bracket arm attaches to the skull mount and the trajectory aiming tower is attached to the mount once it is affixed to the patient skull. The ring assembly of the base is attached to the patient's skull. The socket assembly fits over the two retaining blocks on the ring assembly and is secured with the tower thumbscrews.

The SmartFrame OR Kit consists of the following Components:

• 1x SmartFrame OR Tower ●
• 1x Device Guide, 2.1mm
• 1x Centering Ring ●
• 1x Dock ●
• 1x Lock
• 1x Lock (2.1mm) ●
• 1x SNS Thumb Wheel Extension ●
• . 1x Thumb Screw Pack

The plastic tower assembly is designed to provide multi-directional orientation adjustments to the Device Guide, which is a guide tube encased in the center of the tower assembly. The Device Guide has a 14-gauge central lumen through which a peel away sheath can be placed and oriented.

The tower, when attached to the base assembly, provides adjustments in the roll, pitch, x, and y directions by turning the appropriate thumb wheels. The thumb wheels on the SMARTFrame are used to maneuver the Device Guide by either direct or indirect physician contact.

Acceptance Criteria & Device Performance:

The primary acceptance criterion for the SmartFrame OR device appears to be its targeting accuracy, both in terms of positional error and trajectory angle error, as compared to the predicate device, Medtronic NexFrame.

Here's a table summarizing the reported device performance against implicitly accepted criteria derived from the predicate device's performance:

Study Details:

1. Table of Acceptance Criteria and Reported Device Performance: This has been provided above. The implied acceptance criteria for positional error is that the SmartFrame OR's performance should be at least as good as, if not better than, the predicate device (Medtronic NexFrame). The document states that the NexFrame's targeting accuracy is ±1.48 mm. The SmartFrame OR's mean positional error of 1.36 mm and 99% CI upper bound of 1.57 mm (after adding a 0.25mm measurement tool differential) suggests it performs comparably or better, meeting the implicit acceptance. For trajectory angle error, no direct predicate comparison is given in the table, but the reported values suggest the device performs within acceptable limits for its intended use.

2. Sample Size Used for the Test Set and Data Provenance: The document does not explicitly state the sample size used for the benchtop accuracy testing. The provenance of the data is from bench testing conducted by ClearPoint Neuro, Inc., the device manufacturer. It is a controlled, prospective study in a laboratory setting, not real-world patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications: The document does not mention the involvement of experts in establishing ground truth for the bench testing. Ground truth for the accuracy testing would have been established by the precise design specifications of the device and the accuracy of the measurement tools used in the benchtop environment, not through expert consensus on medical images.

4. Adjudication Method for the Test Set: Not applicable. This was a benchtop accuracy test, not a subjective assessment of medical images requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. This device is a stereotaxic instrument, a hardware-only guidance system, not an AI or imaging diagnostic tool that would typically involve human readers. Therefore, there's no mention of how much human readers improve with AI assistance.

6. Standalone Performance: Yes, the accuracy testing described is a standalone (algorithm/device only) performance evaluation. It measures the physical accuracy of the SmartFrame OR system itself in a controlled environment, without human intervention in the accuracy measurement process.

7. Type of Ground Truth Used: The ground truth for the benchtop accuracy testing was derived from the physical specifications and measurements of the device's components and its ability to guide instruments to a precisely defined target. This is not
   expert consensus, pathology, or outcomes data. It is a calculated and measured ground truth based on engineering principles.

8. Sample Size for the Training Set: The document does not mention a training set. This device is a hardware instrument, not a software algorithm or AI model that requires a training set for development.

9. How Ground Truth for the Training Set Was Established: Not applicable, as there was no training set.

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