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The Synergy® Cranial software is surgical navigation software that, when used with the StealthStation® System as a planning and intraoperative guidance system, is intended to aid in 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 StealthStation® Cranial software, is intended to aid in 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 (including stereotactic frame-based and stereotactic frame alternatives-based procedures):

• Cranial biopsies (including stereotactic)
• Deep brain stimulation (DBS) lead placement
• Depth electrode placement
• Tumor resections
• Craniotomies/Craniectomies
• Skull Base Procedures
• Transsphenoidal Procedures
• Thalamotomies/Pallidotomies
• Pituitary Tumor Removal
• CSF leak repair
• Pediatric Ventricular Catheter Placement
• General Ventricular Catheter Placement

The StealthStation® System, with StealthStation Cranial software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation® Cranial software works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system and platform/computer hardware. Image guidance, 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. StealthStation® Cranial 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.

The provided document is a 510(k) Premarket Notification from Medtronic Navigation Inc. to the FDA for their StealthStation Synergy Cranial S7 Software v.2.2.8 and StealthStation Cranial Software v3.1.1. The document primarily discusses the substantial equivalence of these devices to previously cleared predicate devices.

While it mentions system accuracy requirements and some aspects of testing, it does NOT contain the detailed information typically found in a study proving a device meets acceptance criteria for an AI/ML medical device, especially regarding clinical performance, expert ground truth, multi-reader studies, or large-scale data sets.

The document describes a surgical navigation software, which is a different category from an AI/ML diagnostic or predictive device. The "performance testing" described focuses on 3D positional and trajectory accuracy of the surgical navigation system itself, not on the performance of an AI algorithm in interpreting medical images or making clinical assessments.

Therefore, many of the requested sections about AI/ML device performance (e.g., ground truth methods, sample sizes for training/test sets in the context of AI, expert adjudication, MRMC studies) are not applicable or not provided in this document.

Here's what can be extracted and inferred from the text regarding the device's acceptance criteria and the study that "proves" it meets them, framed within the context of a surgical navigation system:

Device: StealthStation® Synergy Cranial S7 Software v2.2.8 and StealthStation® Cranial Software v3.1.1 (used with the StealthStation® System)

Function: Surgical navigation software intended to aid in precisely locating anatomical structures in neurosurgical procedures.

Nature of Device's "Performance": The performance here refers to the accuracy of the navigation system in guiding surgical instruments, not an AI's ability to interpret images or predict outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

This information is presented within the "Summary of the Technological Characteristics" section, specifically under the "System Accuracy Requirement" for both software versions.

Conclusion: Both subject devices (v2.2.8 and v3.1.1) demonstrate positional and trajectory accuracy values better than or equal to the specified acceptance criteria (which are based on the predicate devices' performance).

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

• Sample Size for Test Set: Not explicitly stated as a numerical 'sample size' of cases or images in the typical AI/ML sense. The document states: "This performance was determined using anatomically representative phantoms and utilizing a subset of system components and features that represent the worst-case combinations of all potential system components." This implies testing was done on physical phantoms rather than patient data.
• Data Provenance: Not applicable in the sense of patient data origin (e.g., country of origin, retrospective/prospective). The testing used "anatomically representative phantoms."

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

• Number of Experts/Qualifications: Not applicable. The "ground truth" for a surgical navigation system's accuracy is typically established by direct physical measurements against known values on precise phantoms, not by expert human interpretation of images for diagnosis or outcomes.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As the "ground truth" is established by physical measurement on phantoms, or engineering validation, there is no need for expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study Done?: No. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation or diagnosis. This document pertains to a surgical navigation system, where the 'device performance' is its physical accuracy, not its interpretative assistance to a human reader.

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

• Standalone Performance: Yes, implicitly. The "System Accuracy" testing is a standalone test of the device's accuracy in a controlled, "worst-case configuration" using phantoms. This measures the device's inherent precision and accuracy independent of direct human-in-the-loop performance during an actual surgery. However, this is not an AI algorithm's standalone performance in a diagnostic sense, but rather an engineering performance metric.

7. The Type of Ground Truth Used

• Type of Ground Truth: Engineering measurements / Physical reference standard. The document states the performance was determined using "anatomically representative phantoms." The ground truth for positional and trajectory accuracy would be the known, precisely measured positions and angles on these phantoms.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable / Not provided. This device is a software for surgical navigation, not an AI/ML model trained on a large dataset of patient images to perform diagnostic or predictive tasks. The software's functionality is based on algorithms that process imaging data (CT, MR) for registration and guidance, not on a machine learning training paradigm.

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

• How Ground Truth for Training Established: Not applicable. As there's no evident "training set" in the AI/ML sense, this question is not relevant. The software's functionality is based on established physics, geometry, and image processing algorithms.

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