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The StealthStation System, with Synergy® Cranial software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure can be identified relative to images of the anatomy.

This can include, but is not limited to, the following cranial procedures:

• Cranial Biopsies
• Tumor Resections
• Craniotomies/Craniectomies
• Skull Base Procedures
• Transsphenoidal Procedures
• Thalamotomies/Pallidotomies
• Pituitary Tumor Removal
• CSF Leak Repair
• Pediatric Catheter Shunt Placement
• General Catheter Shunt Placement

The StealthStation System, with Synergy Cranial v2.2.7 software helps guide surqeons during cranial surgical procedures such as biopsies, tumor resections, and shunt placements. The Synergy Cranial v2.2.7 software works in conjunction with an Image Guided System (IGS) which consists of clinical software, surqical instruments, a referencing system and platform/computer hardware. Image quidance, also called navigation, tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient. Synergy Cranial v2.2.7 software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.

Here's a breakdown of the acceptance criteria and study information for the StealthStation System with Synergy Cranial Software, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a numerical "sample size" for the test set in terms of cases or patients. Instead, it describes:

• Test Setup: "an anatomically representative phantom." This suggests a single or very limited number of phantoms were used to test accuracy.
• Data Provenance: The testing was conducted "in laboratory and simulated use settings." This indicates a retrospective and simulated provenance, not based on real patient data from a specific country.

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

The document does not mention the use of experts to establish ground truth for the test set. The ground truth for accuracy testing on a phantom would typically be established by the precise design and known dimensions of the phantom itself, and the accurate measurement tools used during the test.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. Since the performance testing was based on an anatomically representative phantom and direct measurements of positional and angular error, adjudication by human experts (as would be typical for image interpretation tasks) was not applicable or performed.

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

No, an MRMC comparative effectiveness study was not done. The document does not describe any human reader studies or a comparison of human reader performance with and without AI assistance. The testing focuses solely on the device's inherent accuracy in a simulated environment.

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

Yes, a standalone performance evaluation was conducted. The document states that the testing demonstrated the system's "performance in 3D positional accuracy" and "trajectory angle accuracy." These are measurements of the algorithm/system's precision in guiding instruments, independent of a human's interpretation or decision-making. The device, an Image Guided System (IGS), inherently functions as a standalone guidance system, providing objective measurements to the surgeon.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used for the performance testing was based on the known physical properties and precise measurements of an anatomically representative phantom. This is a form of engineered or objective ground truth, not derived from subjective expert consensus, pathology, or patient outcomes.

8. The Sample Size for the Training Set

The document does not provide any information about the sample size used for a training set. This is typical for a medical device cleared via 510(k) where the focus is on substantial equivalence to a predicate device and performance validation, rather than the development and training of a novel AI algorithm from a large dataset. The Synergy Cranial software is likely a refined version or update to existing navigation software, rather than a de-novo AI model requiring extensive training data.

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

As no training set is described, there is no information on how its ground truth would have been established.

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