(268 days)
Not Found
No
The document describes an image-guided surgical navigation system that tracks instrument position relative to patient anatomy using pre-operative or intra-operative images. It does not mention AI or ML in the device description, intended use, or performance studies. The functionality is described in terms of traditional image processing, registration, and planning, not AI/ML algorithms.
No
The device is an image-guided surgery system intended to aid in locating anatomical structures and guiding surgeons, not to directly treat a medical condition.
No
This device is described as an image-guided surgery system (IGS) intended to aid surgeons in locating anatomical structures during neurosurgical procedures. Its function is to track instrument positions relative to surgical anatomy using pre-operative or intra-operative images, not to diagnose a medical condition itself.
No
The device description explicitly states that the software "works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system and platform/computer hardware." This indicates the device is a system that includes hardware components, not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the system is "intended to aid in locating anatomical structures in either open or percutaneous neurosurgical procedures." This describes a device used during a surgical procedure to guide the surgeon, not a device used to examine specimens (like blood, tissue, or urine) outside of the body to diagnose a condition.
- Device Description: The description reinforces this by explaining that the system "helps guide surgeons during cranial surgical procedures" and "tracks the position of instruments in relation to the surgical anatomy." This is a surgical navigation system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on the analysis of such samples.
In summary, the StealthStation® System with StealthStation® Cranial Software is a surgical navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The StealthStation System, with StealthStation Cranial Software, is intended to aid in 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
- 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 user should consult the "Navigational Accuracy" section of the User Manual to assess if the accuracy of the system is suitable for their needs.
Product codes
HAW
Device Description
The StealthStation® System, with Station® Cranial v3.0 software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation® Cranial v3.0 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 v3.0 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray based, MR based, Nuclear Medicine based
Anatomical Site
Cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Description: Under representative worst-case configuration, the StealthStation® System with StealthStation® Cranial Software, 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 defined as the Euclidean distance from target to instrument tip at final point of insertion. The trajectory angle error is the angle between the planned surgical trajectory and trajectory of the neurosurgical instrument at final point of insertion. Depending on the surgical procedure and the particular neurosurgical instruments used, the resulting navigational accuracy may be negatively impacted.
Data source: anatomically representative phantoms
Annotation protocol: Not Found
Summary of Performance Studies
Study Type: Performance Validation
Sample size: Not specified
Key Results:
Cranial 3.0 Stereotactic Frame System Performance Validation:
Positional Error (mm) - Mean: 1.57, Standard Deviation: 0.63, 99%CI* Upper Bound: 3.04
Trajectory Angle Error (degrees) - Mean: 0.52, Standard Deviation: 0.34, 99%CI* Upper Bound: 1.31
Cranial 3.0 with Nexframe® System Performance Validation:
Positional Error (mm) - Mean: 1.65, Standard Deviation: 0.50, 99%CI* Upper Bound: 2.81
Trajectory Angle Error (degrees) - Mean: 0.68, Standard Deviation: 0.31, 99%CI* Upper Bound: 1.40
Cranial 3.0 with STarFix™ System Performance Validation:
Positional Error (mm) - Mean: 1.08, Standard Deviation: 0.54, 99%CI* Upper Bound: 2.34
Trajectory Angle Error (degrees) - Mean: 0.70, Standard Deviation: 0.42, 99%CI* Upper Bound: 1.68
Cranial 3.0 with EM Localization System Performance Validation:
Positional Error (mm) - Mean: 1.67, Standard Deviation: 0.82, 99%CI* Upper Bound: 3.91
Trajectory Angle Error (degrees) - Mean: 1.31, Standard Deviation: 0.55, 99%CI* Upper Bound: 2.73
Standalone performance: Not specified.
MRMC: Not specified.
AUC: Not specified.
Key Metrics
Positional Error (mm) with Mean, Standard Deviation, and 99%CI* Upper Bound.
Trajectory Angle Error (degrees) with Mean, Standard Deviation, and 99%CI* Upper Bound.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem that resembles an abstract caduceus, with three stylized human profiles forming the staff and a serpent-like shape winding around them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 14, 2016
Medtronic Navigation, Inc. Ms. Augusta Henao Senior Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027
Re: K153660
Trade/Device Name: StealthStation System with StealthStation Cranial Software Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: August 12, 2016 Received: August 15, 2016
Dear Ms. Henao:
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.
1
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 yours,
Carlos L. Pena -$=D/A
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153660
Device Name
StealthStation System with StealthStation Cranial Software
Indications for Use (Describe)
The StealthStation System, with StealthStation Cranial Software, is intended to aid in 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
- 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 user should consult the "Navigational Accuracy" section of the User Manual to assess if the accuracy of the system is suitable for their needs.
Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
September 13, 2016
I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200 Fax Number: 720-890-3500
Contact:
Primary Contact: Augusta Henao Senior Regulatory Affairs Specialist Telephone Number: 720-890-3366 Fax Number: 720-890-3500
Secondary Contact: Michael Blasco Senior Regulatory Affairs Manager Telephone Number: 720-890-3391 Fax Number: 720-890-3500
- Proprietary Trade Name: StealthStation® System with StealthStation® Cranial II. Software
- III. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- Classification: Class II, Stereotaxic Instrument IV.
- V. Product Codes: HAW
VI. Product Description
The StealthStation® System, with Station® Cranial v3.0 software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation® Cranial v3.0 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 v3.0 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.
4
VII. Indications for Use
The StealthStation® System, with Station® Cranial Software, is intended to aid in 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
- · 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 user should consult the "Navigational Accuracy" section of the User Manual to assess if the accuracy of the system is suitable for their needs.
VIII. Summary of the Technological Characteristics
| Item | Subject Device (StealthStation®
System with StealthStation® Cranial
v3.0 Software) | Predicate Devices |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The StealthStation® System, with
StealthStation® Cranial software is
designed as an aid for locating
anatomical structures in either open or
percutaneous neurosurgical procedures. | Synergy® Cranial v2.2.7 Software -
K150216
The StealthStation® System, with
Synergy® Cranial software is designed as
an aid for precisely locating anatomical
structures in either open or percutaneous
neurosurgical procedures. |
| Indications for
Use | The StealthStation® System, with
StealthStation® Cranial Software, is
intended to aid in 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. | Synergy® Cranial v2.2.7 Software -
K150216
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. |
| Item | Subject Device (StealthStation®
System with StealthStation® Cranial
v3.0 Software) | Predicate Devices |
| | This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures):
- Cranial Biopsies
- 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 user should consult the “Navigational Accuracy” section of the User Manual to assess if the accuracy of the system is suitable for their needs | 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 |
| System
Accuracy
Requirement | The StealthStation® System with StealthStation Cranial v3.0 Software, has demonstrated performance in 3D positional accuracy with a mean error $\le$ 2.0 mm and in trajectory angle accuracy with a mean error $\le$ 2.0 degrees. | Synergy® Cranial v2.2.7 Software - K150216
The StealthStation® System with Synergy Cranial Software, has demonstrated performance in 3D positional accuracy with a mean error $\le$ 2.0 mm and in trajectory angle accuracy with a mean error $\le$ 2.0 degrees. |
| Imaging
Modalities | X-Ray based, MR based, Nuclear Medicine based | Synergy® Cranial v2.2.7 Software - K150216
X-Ray based, MR based, Nuclear Medicine based |
| View (Display)
Features | Ultrasound Video In, Ultrasound
Overlay,
3D, 2D Anatomic Orthogonal,
Trajectory 1 and 2, Target Guidance,
Trajectory Guidance, Probes Eye,
Look Ahead, Microscope Injection,
Video Input | Synergy® Cranial v2.2.7 Software - K150216
Ultrasound Video In, Ultrasound Overlay,
3D, 2D Anatomic Orthogonal, Trajectory
1 and 2, Target Guidance, Trajectory
Guidance, Probes Eye, Look Ahead,
Microscope Injection, Video Input |
| Exam-to-Exam
Registration
Features | Identity Merge Registration, Manual
Merge Registration and Automatic
Merge Registration | Synergy® Cranial v2.2.7 Software - K150216
Identity Merge Registration, Manual |
| Item | Subject Device (StealthStation® System with StealthStation® Cranial v3.0 Software) | Predicate Devices |
| Patient
Registration
Features | PointMerge registration, Tracer registration, Touch-N-Go registration, StealthAiR registration, O-arm registration, Stereotactic Localizer Registration and StarFix Bone Anchor Registration | Merge Registration and Automatic Merge Registration.
Primary Predicate:
Synergy® Cranial v2.2.7 Software - K150216
PointMerge registration, Tracer registration, Touch-N-Go registration, StealthAiR registration and O-arm registration
Secondary Predicate:
Natrex™ Device for StealthStation System K992927
Stereotactic Localizer Registration |
| Planning
Features | Plan Entry and Target Selection
3D Model Building
Advanced Visualization
Create Patient Based Anatomical Coordinate Space
Stereotactic Frame Settings
Brain Atlas: Schaltenbrand-Wahren Atlas with Talairach Grid
STarFix Designer
Annotations | Primary Predicate:
Synergy® Cranial v2.2.7 Software - K150216
Plan Entry and Target Selection
3D Model Building
Advanced Visualization
Secondary Predicate:
Natrex™ Device for StealthStation® System K992927
Stereotactic Localizer Registration
Plan Entry and Target Selection
Create Patient Based Anatomical Coordinate Space
Stereotactic Frame Settings
Brain Atlas: Schaltenbrand-Wahren Atlas with Talairach Grid
Annotations |
| Medical Device
Interfaces | Microscope Navigation: Zeiss, Leica
Ultrasound Navigation: Aloka and Sonosite
Medtronic O-arm
Stereotactic Frame Systems: Fischer ZD, Fischer RM, Integra CRW and Elekta Leksell
Nexframe® Stereotactic System
STarFix™Platform System | Primary Predicate:
Synergy® Cranial v2.2.7 Software - K150216
Microscope Navigation: Zeiss, Leica
Ultrasound Navigation: Aloka and Sonosite
Medtronic O-arm
Secondary Predicate:
Natrex™ Device for StealthStation® System K992927
Stereotactic Frame Systems: Integra BRW/CRW and Leksell |
| Software
Interface (GUI) | Blue style with chronological next/back task flow at the top of the screen.
Image controls on the left. Planning | Synergy® Cranial v2.2.7 Software - K150216
Blue style with chronological next/back |
| Item | Subject Device (StealthStation®
System with StealthStation® Cranial
v3.0 Software) | Predicate Devices |
| | information on the right. | task flow at the top of the screen. Image
controls on the left. Planning information
on the right. |
| Programming
Language | C++ | Synergy® Cranial v2.2.7 Software -
K150216
C++ |
| Scanner
Interface
Technology (to
imaging devices) | Network Connectivity
CD, DVD, USB
DICOM Import
DICOM Export | Synergy® Cranial v2.2.7 Software -
K150216
Network Connectivity
CD, DVD, USB
DICOM or Stealth format Import
Export in Stealth format |
| Localization
Technology | Optical (infra-red)
Electromagnetic
Mechanical based stereotactic | Primary Predicate:
Synergy® Cranial v2.2.7 Software -
K150216
Optical (infra-red)
Electromagnetic
Secondary Predicate:
Natrex™ Device for StealthStation
System K992927
Optical (infra-red),
Mechanical based stereotactic |
5
6
7
IX. Identification of Legally Marketed Devices
StealthStation® System with Synergy Cranial Software (K150216) Natrex Device for StealthStation® System (K992927)
X. Discussion of the Performance Testing
The following table summarizes the testing conducted on the StealthStation® System with StealthStation® Cranial v3.0 Software:
Description
Under representative worst-case configuration, the StealthStation® System with StealthStation® Cranial Software, 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 defined as the Euclidean distance from target to instrument tip at final point of insertion. The trajectory angle error is the angle between the planned surgical trajectory and trajectory of the neurosurgical instrument at final point of insertion. Depending on the surgical procedure and the particular neurosurgical instruments used, the resulting navigational accuracy may be negatively impacted.
8
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 in a clinically relevant workflow.
The test configuration for stereotactic frame-based, Nexframe®, and STarFix™ procedures included CT images with slice spacing and thickness of 1.25 mm and T2-weighted MR images with slice spacing and thickness of 1.0 mm. The following table summarizes the performance of the StealthStation® System using Cranial software with compatible stereotactic hardware platforms.
| Performance Validation | Positional Error (mm) | Trajectory Angle Error (degrees) | ||||
|---|---|---|---|---|---|---|
| Mean | Standard Deviation | 99%CI* Upper Bound | Mean | Standard Deviation | 99%CI* Upper Bound | |
| Cranial 3.0 Stereotactic Frame System Performance Validation | 1.57 | 0.63 | 3.04 | 0.52 | 0.34 | 1.31 |
| Cranial 3.0 with Nexframe® System Performance Validation | 1.65 | 0.50 | 2.81 | 0.68 | 0.31 | 1.40 |
| Cranial 3.0 with STarFix™ System Performance Validation | 1.08 | 0.54 | 2.34 | 0.70 | 0.42 | 1.68 |
*CI (Confidence Interval)
The test configuration for procedures using electromagnetic localization included CT images with slice spacing and thickness of 1.0 mm and T1-weighted MR images with slice spacing and thickness of 1.5 mm. The following table summarizes the performance of the Cranial software on the StealthStation System with electromagnetic (EM) localization.
| Performance Validation | Positional Error (mm) | Trajectory Angle Error (degrees) | ||||
|---|---|---|---|---|---|---|
| Mean | Standard Deviation | 99%CI* Upper Bound | Mean | Standard Deviation | 99%CI* Upper Bound | |
| Cranial 3.0 with EM Localization System Performance Validation | 1.67 | 0.82 | 3.91 | 1.31 | 0.55 | 2.73 |
*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® System with Station® Cranial v3.0 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 cranial surgical procedures using anatomical phantoms.
9
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 |
Clinical testing was not considered necessary prior to release as this is not new technology.
XI. Conclusions
The non-clinical data support the safety of the device and the software verification and validation demonstrate that the StealthStation® System with StealthStation® Cranial v3.0 software should perform as intended in the specified use conditions. The non-clinical data demonstrate that the StealthStation® System with StealthStation® Cranial v3.0 software performs comparably to the predicate devices for the same intended use.