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

Device Description

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.

AI/ML Overview

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.

Performance Validation	Positional Error (mm)	Trajectory Angle Error (degrees)
Acceptance Criteria	Mean < 2.0 mm (from Predicate)	Not explicitly stated as acceptance criteria in the provided text, but reported as a performance metric.
S8 Spine Software (Reported)	Mean: 1.30	Mean: 0.64
	Standard Deviation: 0.50	Standard Deviation: 0.33
	99% CI* Upper Bound: 2.65	99% CI* Upper Bound: 1.61

*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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 1, 2017

Medtronic Navigation John Connor Senior Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K170011

Trade/Device Name: StealthStation S8 Spine Software V1.0.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 24, 2017 Received: March 27, 2017

Dear John Connor:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170011

Device Name StealthStation S8 Spine Software v1.0.0

Indications for Use (Describe)

o Pedicle Screw Placement

o Iliosacral Screw Placement
o Interbody Device Placement

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

December 30, 2016

I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, CO 80020 USA Telephone Number: (720) 890-3200 Fax Number: (720-890-3500)
- Contact: John Connor Senior Regulatory Affairs Specialist Telephone number: (720) 890-2311 Fax: (720) 890-3500 Email: john.m.connor@medtronic.com
II. Proprietary Trade Name: StealthStation S8 Spine Software v1.0.0
III. Common Name: Orthopedic Stereotaxic Instrument
IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
V. Classification: Class II
VI. Product Code: OLO

VII. Product Description:

VIII. Indications for Use:

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.

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This can include the following spinal implant procedures, such as:

Pedicle Screw Placement •
. Iliosacral Screw Placement
Interbody Device Placement

IX. Identification of Legally Marketed Devices (Predicate Devices)

StealthStation System Update (K050438, Main Predicate) .
Synergy Cranial 3.0 Software (K153660, System Accuracy Predicate) .

X. Comparison of the Technological Characteristics:

Item	Subject Device (StealthStationSpine Software)	Predicate Device (Synergy SpineSoftware)
Intended Use	The StealthStation System, withStealthStation Spine Software, isintended as an aid for preciselylocating anatomical structures ineither open or percutaneousneurosurgical and orthopedicprocedures.	The StealthStation System isintended as an aid for preciselylocating anatomical structures ineither open or percutaneousprocedures.
Indicationsfor Use	The StealthStation System, withStealthStation Spine Software, isintended as an aid for preciselylocating anatomical structures ineither open or percutaneousneurosurgical and orthopedicprocedures. Their use is indicatedfor any medical condition in whichthe use of stereotactic surgery maybe appropriate, and wherereference to a rigid anatomicalstructure, such as the spine orpelvis, can be identified relative toimages of the anatomy.This can include the followingspinal implant procedures, such as:● Pedicle Screw Placement● Iliosacral Screw Placement● Interbody Device Placement	The StealthStation System isintended as an aid for preciselylocating anatomical structures ineither open or percutaneousprocedures. The StealthStationSystem is indicated for any medicalcondition in which the use ofstereotactic surgery may beappropriate, and where reference toa rigid anatomical structure, such asthe skull, a long bone, or vertebra,can be identified relative to a CT orMR based model, fluoroscopyimages, or digitized landmarks ofthe anatomy. Example proceduresinclude, but are not limited to:● Spinal Implant Procedures,such as Pedicle ScrewPlacement● Placement of Iliosacral Screws● Stabilization and Repair ofPelvic Fractures
SystemAccuracyRequirement	System Level Accuracy with amean positional error of 2.0mm	System Level Accuracy with amean positional error of 2.0mm and
	(Requirement from Cranial 3.0Predicate)	(Requirement from Cranial 3.0Predicate)
ImagingModalities	X-Ray Based Imaging	X-Ray Based Imaging
RegistrationFeatures	PointMerge RegistrationSurfaceMerge RegistrationFluoroMerge RegistrationAutomatic 2D Image RegistrationAutomatic 3D Image Registration	PointMerge RegistrationSurfaceMerge RegistrationFluoroMerge RegistrationAutomatic 2D Image RegistrationAutomatic 3D Image Registration
PlanningFeatures	Plan Entry and Target Selection3D Model BuildingDeformity Planning	Plan Entry and Target Selection3D Model BuildingDeformity Planning
MedicalDeviceInterfaces	O-arm Imaging SystemZiehm Vision FD Vario 3D C-ArmISO-C 3D C-ArmOrbic 3D C-Arm	O-arm Imaging SystemZiehm Vision FD Vario 3D C-ArmISO-C 3D C-ArmOrbic 3D C-Arm
View(Display)Features	Look Sideways3DAnatomic OrthogonalTrajectory 1 and 2Trajectory GuidanceLook AheadProbe's EyeAP and LateralSynthetic AP and LateralMaximum Intensity ProjectionVideo Input	Look Sideways3DAnatomic OrthogonalTrajectory 1 and 2Trajectory GuidanceLook AheadProbe's EyeAP and LateralSynthetic AP and LateralMaximum Intensity ProjectionVideo Input
SoftwareInterface(GUI)	Black and gray style withprocedure task overview in leftmenu option and next/back taskflow at bottom of the screen.Software controls for images,planning and instrumentmanagement are contained in aright side bar.	Basic gray and black style with 4main tasks and tab interface toaccess tools. Controls on the right.
ProgrammingLanguage	C++	C++
ScannerInterfaceTechnology(to imagingdevices)	Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export	Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export
LocalizationTechnology	Optical	Optical

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XI. Discussion of the Performance Testing

The following table summarizes the testing conducted on the StealthStation S8 Spine Software v1.0.0

Description

Under representative worst-case configuration, the StealthStation S8 Spine Software v1.0.0 has demonstrated performance in 3D positional accuracy with a mean error < 2.0 mm and in trajectory angle accuracy with a mean error ≤ 2.0 degrees. The positional error is calculated from the difference in the tip position of the instrument and the intended surgical target/entry point. The trajectory error is calculated from the difference in the instrument orientation and the trajectory of the intended surgical plan.

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. The following table summarizes the performance of the StealthStation S8 Spine Software v1.0.0:

PerformanceValidation	Positional Error (mm)			Trajectory Angle Error(degrees)
	Mean	StandardDeviation	99% CI*UpperBound	Mean	StandardDeviation	99% CI*UpperBound
S8 SpineSoftware	1.30	0.50	2.65	0.64	0.33	1.61

*CI (Confidence Interval)

Medtronic developed a test method to simulate clinical configurations and workflows to derive this summary of performance. Due to the uniqueness of this test method, the performance results presented may not be comparable to results derived from other test methods or other medical devices.

Software verification and validation testing for each requirement specification. Design verification and validation was performed using the StealthStation S8 Spine Software v1.0.0 software in laboratory and simulated use settings. The results support the safety of the device and demonstrate that the software should perform as intended in the specified use conditions.

System integration performance testing for spine surgical procedures using anatomical phantoms.

The following table summarizes the quality assurance measures that were applied during development of the software component of the system:

Description
Software Development Life Cycle
Software Risk Assessment
Software Configuration Management and Version Control

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XII. Conclusions

The StealthStation S8 Spine Software v1.0.0 has been shown through comparison and testing to be substantially equivalent to the identified predicate devices.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).