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The StealthStation™ System, with StealthStation™ Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures in adult and skeletally mature pediatric (adolescent) patients. 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 in adult patients, such as:

• Pedicle Screw Placement
• Iliosacral Screw Placement
• Interbody Device Placement

This can include the following spinal implant procedures in skeletally mature pediatric (adolescent) patients:

• Pedicle Screw Placement

StealthStation S8 Spine Software helps guide surgeons during spine surgical procedures. The subject software works in conjunction with a navigation system, surgical instruments, a referencing system, and computer hardware. Navigation tracks the position of instruments in relation to the surgical anatomy and identifies this position on pre-operative or intraoperative images of the patient. The mouse, keyboard, touchscreen monitor, and footswitch of the StealthStation platforms are used to move through the software workflow. Patient images are displayed by the software from a variety of perspectives (axial, sagittal, coronal, oblique) and 3-dimensional (3D) renderings. During navigation, the system identifies the tip location and trajectory of the tracked instrument on images and models the user has selected to display on the monitor. The surgeon may also create and store one or more surgical plan trajectories before and during surgery and simulate progression along these trajectories. During surgery, the software can display how the actual instrument tip position and trajectory relate to the plan, helping to guide the surgeon along the planned trajectory.

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The StealthStation™ System, with StealthStation™ 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.

Based on the provided text, the acceptance criteria and study proving the device meets these criteria for the StealthStation S8 Spine Software v1.3.0 can be summarized as follows:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify a numerical sample size for the test set used for the accuracy performance. It mentions "anatomically representative phantoms" were used.
• Data Provenance: The study was conducted using "anatomically representative phantoms." The country of origin of the data is not specified, but the applicant company is Medtronic Navigation, Inc., located in Louisville, Colorado, USA. The study design is implied to be prospective testing on phantoms rather than retrospective patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The accuracy testing was performed on phantoms, which typically rely on engineered and measurable ground truth, not expert consensus on anatomical structures or clinical outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided in the document, as the ground truth for phantom testing is typically established by the design of the phantom and measurement techniques, not human adjudication.

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:

No MRMC comparative effectiveness study was mentioned. The device, StealthStation S8 Spine Software, is an image-guided surgery system, not an AI-assisted diagnostic tool that would typically be evaluated with MRMC studies comparing human reader performance. The software aids surgeons in precisely locating anatomical structures.

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

The device's performance was evaluated in terms of its ability to measure positional and trajectory accuracy on phantoms. This can be considered a form of standalone performance assessment as it evaluates the system's inherent accuracy capabilities, albeit in a simulated (phantom) environment, without directly measuring human-in-the-loop clinical workflow improvement. The text refers to "System integration performance testing for spine surgical procedures using anatomical phantoms."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth was established by the design and measurement capabilities of the "anatomically representative phantoms." This type of ground truth is based on precise, engineered physical properties and known measurements of the phantom. It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

This information is not provided in the document. The document describes a software update (v1.3.0) to an existing device, and the focus of the 510(k) summary is on performance testing for substantial equivalence, not on the training data used for the algorithm's development.

9. How the ground truth for the training set was established:

This information is not provided in the document. As this document is a 510(k) summary for a software update, details about the original model training and ground truth establishment are typically not included unless significant changes related to the algorithm's core functionality or AI components are introduced which necessitate new data for training or re-training.

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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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