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The Optical Tracking System (OTS) is a graphical planning tool that allows for preoperative and operative planning of surgical procedures. The OTS is indicated for use in surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.

The Optical Tracking System (OTS), addressed in this premarket notification, has the same intended use and similar technological characteristics as the commercially available Radionics Operating Arm System and the StealthStation Stereotactic System. The OTS is a modification of the Operating Arm System but substitutes a camera array for the operating arm to track the position of probes and various tools. This is the same camera array utilized by StealthStation. The OTS provides an interactive, image-guided means of localizing targets in surgical procedures. In addition to the camera array, the OTS consists of a computer workstation, application software, and probes. Upon calibration of the system in the surgical environment, the surgeon selects points on the patient using a probe which are interpreted by the computer and related to corresponding points on the image.

Here's a breakdown of the acceptance criteria and study information for the Optical Tracking System (OTS), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text explicitly states: "The results from the OTS are compared to a phantom with targets of known position."

• Sample Size for Test Set: The text does not specify a numerical sample size for the targets on the phantom. It only mentions "targets of known position."
• Data Provenance: The data is generated through testing with a phantom (a physical model with known properties), not clinical patient data. Therefore, it is a simulated/laboratory setting, not retrospective or prospective clinical data from a specific country.

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

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

The ground truth for this device's performance test is established by the known, pre-defined positions of targets on a phantom. Human experts are not involved in establishing this ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

Since the ground truth is established by the known positions on a phantom, there is no need for human adjudication of the test results. The device's measurements are directly compared to these known values.

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

• MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done.

This submission is for an image-guided surgical planning tool, not an AI diagnostic tool. The performance evaluation focuses on the system's accuracy in tracking and localization, not on changes in human reader performance with or without AI assistance.

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

• Standalone Performance: Yes, a standalone performance evaluation was done.

The reported accuracy of "0.3 mm" for the camera array appears to be a standalone measurement of the system's ability to track positions against a known phantom. While the system is intended for use with a surgeon ("human-in-the-loop"), the verification of its core accuracy is performed independently of a surgeon's interpretation or action, by comparing its output to predefined phantom targets. The statement "RSA Optical Tracking System (OTS) systems testing verifies that the stereotactic CT and MR localizer transformation equations are correctly encoded into the application software. Further, it verifies that all target coordinate input and displays are accurate. The results from the OTS are compared to a phantom with targets of known position. The camera array is accurate to a mean value of 0.3 mm. This accuracy is maintained over a period of extended operation" describes a standalone evaluation of the device's technical specifications.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: The ground truth used is based on known, pre-defined positions of targets on a phantom. This is a form of physical/engineering ground truth.

8. The Sample Size for the Training Set

• Sample Size for Training Set: The document does not provide information about a training set. This device is described as an "Optical Tracking System," not a machine learning or AI algorithm that would typically require a training set in the modern sense. Its functionality is based on established principles of optical tracking and geometry.

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

• How Ground Truth for Training Set Was Established: Not applicable, as no training set is mentioned or implied for this type of device in the provided text.

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