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The StealthStation® System, with Station Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy. This can include the following spinal implant procedures, such as:
o Pedicle Screw Placement

• o Iliosacral Screw Placement
  o Interbody Device Placement

The StealthStation System, also known as an Image Guided System (IGS), is comprised of a platform, clinical software, surgical instruments and a referencing system. The IGS tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The StealthStation Spine software helps guide surgeons during spine procedures such as spinal fusion and trauma treatments. StealthStation Spine 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 StealthStation S8 Spine Software v1.0.0 is an image-guided system (IGS) intended to aid in precisely locating anatomical structures during open or percutaneous neurosurgical and orthopedic procedures, specifically for spinal implant procedures such as pedicle screw placement, iliosacral screw placement, and interbody device placement.

Here's a breakdown of its acceptance criteria and the study proving it meets these criteria:

1. Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against specific accuracy requirements.

*CI (Confidence Interval)

Interpretation: The reported mean positional error of 1.30 mm is well within the acceptance criterion of a mean error less than 2.0 mm. While a specific acceptance criterion for trajectory angle error wasn't explicitly stated as a numerical threshold in the provided text, the reported mean of 0.64 degrees and upper bound of 1.61 degrees indicate good performance in this metric as well.

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

• Sample Size: The document does not explicitly state the numerical sample size (e.g., number of tests, number of phantom runs) for the performance testing. It mentions that testing was conducted "Under representative worst-case configuration" and "utilizing a subset of system components and features that represent the worst-case combinations of all potential system components."
• Data Provenance: The testing was conducted in "laboratory and simulated use settings" using "anatomically representative phantoms." There is no indication of patient data or data provenance from specific countries; the testing was a controlled, simulated environment. The study is prospective in the sense that the device's performance was evaluated through specifically designed tests, not retrospectively on collected clinical data.

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

This information is not provided in the document. The ground truth for the performance testing appears to be based on the known, precise measurements and configurations of the anatomically representative phantoms used in the laboratory setting, rather than expert interpretation of clinical images.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given that the testing involved objective physical measurements on phantoms (positional and trajectory error) rather than subjective human interpretation, a human adjudication method (like 2+1 or 3+1 consensus) would not be applicable or necessary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not explicitly mentioned or performed based on the provided text.
• The study focuses on the system's accuracy in a standalone fashion (measuring positional and trajectory errors) rather than its impact on human reader performance. The device is a navigation aid, implying human-in-the-loop use, but the reported study does not evaluate improvement in human accuracy with or without the device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, a standalone study was performed. The performance validation described ("Performance Validation: Positional Error (mm) and Trajectory Angle Error (degrees)") assesses the intrinsic accuracy of the StealthStation S8 Spine Software itself when used with the integrated system components, outside of a clinical human-in-the-loop workflow. It measures the system's ability to accurately track and locate points relative to a defined ground truth on phantoms.

7. Type of Ground Truth Used

The ground truth used for the performance testing was objective, physical measurements on anatomically representative phantoms. The positional and trajectory errors were calculated by comparing the device's reported positions/trajectories to the known, precise positions and trajectories embedded or defined within the phantom setup. It is not based on expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

This information is not provided in the document. The document describes verification and validation testing for the device's performance and system integration, but it does not detail any machine learning model training or a "training set" in that context. The software's functionality is described in terms of feature sets (imaging modalities, registration, planning, interfaces, views), suggesting a traditional software development rather than a deep learning approach that would require a distinct training set.

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

As no "training set" in the context of machine learning was mentioned or implied, this information is not applicable based on the provided text.

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