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

Device Description

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.

AI/ML Overview

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.

Criterion Type	Acceptance Criterion (Predicate Device Performance)	Reported Device Performance (Subject Device - Synergy Cranial v2.2.8)	Reported Device Performance (Subject Device - Cranial v3.1.1)
3D Positional Accuracy	Mean error ≤ 2.0 mm (for both predicates K150216 and K153660)	0.70 mm	1.16 mm
Trajectory Angle Accuracy	Mean error ≤ 2.0 degrees (for both predicates K150216 and K153660)	0.46 degrees	0.41 degrees

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 31, 2019

Medtronic Navigation Inc. Elizabeth Waite Principal Regulatory Affairs Specialist 826 Coal Creek Circle Louisville. Colorado 80027

Re: K190672

Trade/Device Name: StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: March 14, 2019 Received: March 15, 2019

Dear Elizabeth Waite:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Matthew Krueger Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190672

Device Name Synergy® Cranial Software

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Indications for Use

510(k) Number (if known) K190672

Device Name StealthStation Cranial Software

Indications for Use (Describe)

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

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

April 18, 2019

I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200 Fax Number: 720-890-3500
- Contact: K. Elizabeth Waite (Primary) Principal Regulatory Affairs Specialist Telephone Number: 720-890-2182 Fax Number: 720-890-3500

Rishi Sinha (Alternate) Regulatory Affairs Manager Telephone Number: 720-890-2485 Fax Number: 720-890-3500

II. Proprietary Trade Name: StealthStation® Cranial Software
III. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
IV. Classification: Class II, Stereotaxic Instrument
V. Product Codes: HAW
VI. Predicates: Medtronic Navigation, Inc. manufactured software;
- K150216, StealthStation System with Synergy Cranial v2.2.7 software ●
- K153660, StealthStation System with StealthStation Cranial v3.0 Software .

VII. Product Description

The StealthStation® System, with StealthStation Cranial software helps quide 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 quidance, also called navigation, tracks the position of instruments in relation to the surqical anatomy and identifies this position on diagnostic or intraoperative images of the patient. StealthStation® Cranial

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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.

VIII. Indications for Use

Cranial Software v2.2.8

The StealthStation System, with Synerqy 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.

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

Cranial Software v3.1.1

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

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Transsphenoidal Procedures
Thalamotomies/Pallidotomies
Pituitary Tumor Removal
CSF leak repair
Pediatric Ventricular Catheter Placement
General Ventricular Catheter Placement

IX. Summary of the Technological Characteristics

StealthStation Cranial Software v2.2.8 as compared to Predicate Device

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StealthStation Cranial Software v3.1.1 as compared to Predicate Device

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X. Identification of Legally Marketing Devices

StealthStation® System with Synergy Cranial Software (K150216) StealthStation® System with Cranial Software (K150663)

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XI. Discussion of the Performance Testing

The following table summarizes the testing conducted on the StealthStation® System with StealthStation® Cranial 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 traiectory angle accuracy with a mean error ≤ 2.0 degrees. 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 test configurations included CT images with slice spacing and thickness ranging between 0.6 mm to 1.25 mm and T1-weighted MR images with slice spacing and thickness ranging between 1.0 mm to 3.0 mm. In the imaging protocol, we recommend slice spacing and thickness for CT and MR imaging to be 1.0 mm or less.

Software verification and validation testing for each requirement specification. Design verification and validation was performed using the StealthStation Cranial 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.

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

XII. Conclusions

The StealthStation Cranial software has been shown through testing and comparison 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).

	Subject Device	Predicate Device
	StealthStation System with Synergy Cranial	K150216 StealthStation System with
Item	v2.2.8 Software	Synergy Cranial v2.2.7 Software
Intended Use	The StealthStation® System, withSynergy® Cranial software is designed asan aid for precisely locating anatomicalstructures in either open or percutaneousneurosurgical procedures.	The StealthStation® System, withSynergy® Cranial software is designed asan aid for precisely locating anatomicalstructures in either open or percutaneousneurosurgical procedures.
Indications for Use	The StealthStation System, with SynergyCranial software, is intended as an aid forprecisely locating anatomical structures ineither open or percutaneous neurosurgicalprocedures. The system is indicated forany medical condition in which reference toa rigid anatomical structure can beidentified relative to images of theanatomy.This can include, but is not limited to, thefollowing 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 SynergyCranial software, is intended as an aid forprecisely locating anatomical structures ineither open or percutaneous neurosurgicalprocedures. The system is indicated forany medical condition in which reference toa rigid anatomical structure can beidentified relative to images of theanatomy.This can include, but is not limited to, thefollowing 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 AccuracyRequirement	Under representative worst-caseconfiguration, the StealthStation® Systemwith Synergy Cranial Software, hasdemonstrated performance in 3D positionalaccuracy with a mean error ≤ 2.0 mm andin trajectory angle accuracy with a meanerror ≤ 2.0 degrees.Specific Mean Accuracy Values	Under representative worst-caseconfiguration, the StealthStation® Systemwith Synergy® Cranial Software, hasdemonstrated performance in 3D positionalaccuracy with a mean error ≤ 2.0 mm andin trajectory angle accuracy with a meanerror ≤ 2.0 degrees.Specific Mean Accuracy Values
	Positional Error - 0.70 mm	Position Error - ≤ 2.00 mm
Item	Subject DeviceStealthStation System with Synergy Cranialv2.2.8 Software	Predicate DeviceK150216 StealthStation System withSynergy Cranial v2.2.7 Software
	Trajectory Error - 0.46 degrees	Trajectory Error - ≤ 2.0°
Imaging Modalities	X-Ray based,MR basedNuclear Medicine based	X-Ray based,MR basedNuclear Medicine based
RegistrationFeatures	Exam-to-Exam Registration: Identity MergeRegistration, Manual Merge Registrationand Automatic Merge Registration.Patient Registration: PointMergeregistration, Tracer registration, Touch-N-Go registration, StealthAiR registration andO-arm registration	Exam-to-Exam Registration: Identity MergeRegistration, Manual Merge Registrationand Automatic Merge Registration.Patient Registration: PointMergeregistration, Tracer registration, Touch-N-Go registration, StealthAiR registration andO-arm registration
Planning Features	Plan Entry and Target Selection3D Model BuildingAdvanced Visualization	Plan Entry and Target Selection3D Model BuildingAdvanced Visualization
Medical DeviceInterfaces	Microscope Navigation: Zeiss, LeicaUltrasound Navigation: Aloka and SonositeMedtronic O-arm	Microscope Navigation: Zeiss, LeicaUltrasound Navigation: Aloka and SonositeMedtronic O-arm
View (Display)Features	Ultrasound Video In, Ultrasound Overlay,3D, 2D Anatomic Orthogonal, Trajectory 1and 2, Target Guidance, TrajectoryGuidance, Probes Eye, Look Ahead,Microscope Injection, Video Input	Ultrasound Video In, Ultrasound Overlay,3D, 2D Anatomic Orthogonal, Trajectory 1and 2, Target Guidance, TrajectoryGuidance, Probes Eye, Look Ahead,Microscope Injection, Video Input
Software Interface(GUI)	Blue style with chronological next/backtask flow at the top of the screen. Imagecontrols on the left. Planning informationon the right.	Blue style with chronological next/backtask flow at the top of the screen. Imagecontrols on the left. Planning informationon the right.
ProgrammingLanguage	C++	C++
Scanner InterfaceTechnology (toimaging devices)	Network ConnectivityCD, DVD, USBDICOM or Stealth format ImportExport in Stealth format	Network ConnectivityCD, DVD, USBDICOM or Stealth format ImportExport in Stealth format
LocalizationTechnology	Optical (infra-red)Electromagnetic	Optical (infra-red)Electromagnetic

Item	Subject Device	Predicate Device
Intended Use	StealthStation System with Cranial v3.1.1SoftwareThe StealthStation® System, withStealthStation® Cranial software isdesigned as an aid for locating anatomicalstructures in either open or percutaneousneurosurgical procedures.	K153660 StealthStation System withStealthStation Cranial v3.0 SoftwareThe StealthStation® System, withStealthStation® Cranial software isdesigned as an aid for locating anatomicalstructures in either open or percutaneousneurosurgical procedures.
Item	Subject Device	Predicate Device
	StealthStation System with Cranial v3.1.1	K153660 StealthStation System with
	Software	StealthStation Cranial v3.0 Software
Indications for Use	The StealthStation® System, withStealthStation® Cranial software, isintended to aid in locating anatomicalstructures in either open or percutaneousneurosurgical procedures. The system isindicated for any medical condition inwhich reference to a rigid anatomicalstructure can be identified relative toimages of the anatomy.	The StealthStation® System, withStealthStation® Cranial software, isintended to aid in locating anatomicalstructures in either open or percutaneousneurosurgical procedures. The system isindicated for any medical condition inwhich reference to a rigid anatomicalstructure can be identified relative toimages of the anatomy.
	This can include, but is not limited to, thefollowing cranial procedures (includingstereotactic frame-based and stereotacticframe 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 PlacementThe user should consult the "NavigationalAccuracy" section of the User Manual to	This can include, but is not limited to, thefollowing cranial procedures (includingstereotactic frame-based and stereotacticframe 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 PlacementThe user should consult the "NavigationalAccuracy" section of the User Manual to
	assess if the accuracy of the system issuitable to their needs.	assess if the accuracy of the system issuitable to their needs.
System AccuracyRequirement	Under representative worst-caseconfiguration, the StealthStation® Systemwith StealthStation Cranial v3.0 Software,has demonstrated performance in 3Dpositional accuracy with a mean error ≤2.0 mm and in trajectory angle accuracywith a mean error ≤ 2.0 degrees.Specific Mean Accuracy Values	Under representative worst-caseconfiguration, the StealthStation® Systemwith StealthStation® Cranial v3.0 Software,has demonstrated performance in 3Dpositional accuracy with a mean error ≤2.0 mm and in trajectory angle accuracywith a mean error ≤ 2.0 degrees.Specific Mean Accuracy Values
	Positional Error – 1.16 mmTrajectory Error – 0.41 degrees	Position Error - ≤ 2.00 mmTrajectory Error - ≤ 2.0°
Imaging Modalities	X-Ray based,MR basedNuclear Medicine based	X-Ray based,MR basedNuclear Medicine based
	Subject Device	Predicate Device
	StealthStation System with Cranial v3.1.1Software	K153660 StealthStation System withStealthStation Cranial v3.0 Software
Item
RegistrationFeatures	Exam-to-Exam Registration: Identity MergeRegistration, Manual Merge Registrationand Automatic Merge Registration.Patient Registration: PointMergeregistration, Tracer registration, Touch-N-Go registration, StealthAiR registration, O-arm registration, Stereotactic LocalizerRegistration and StarFix Bone AnchorRegistration	Exam-to-Exam Registration: Identity MergeRegistration, Manual Merge Registrationand Automatic Merge Registration.Patient Registration: PointMergeregistration, Tracer registration, Touch-N-Go registration, StealthAiR registration, O-arm registration, Stereotactic LocalizerRegistration and StarFix Bone AnchorRegistration
Planning Features	Plan Entry and Target Selection3D Model BuildingAdvanced VisualizationCreate Patient Based AnatomicalCoordinate SpaceStereotactic Frame SettingsBrain Atlas: Schaltenbrand-Wahren Atlaswith Talairach GridSTarFix DesignerAnnotations	Plan Entry and Target Selection3D Model BuildingAdvanced VisualizationCreate Patient Based AnatomicalCoordinate SpaceStereotactic Frame SettingsBrain Atlas: Schaltenbrand-Wahren Atlaswith Talairach GridSTarFix DesignerAnnotations
Medical DeviceInterfaces	Microscope Navigation: Zeiss, LeicaUltrasound Navigation: Aloka and SonositeMedtronic O-armStereotactic Frame Systems: Fischer ZD,Fischer RM, Integra CRW and LeksellNexframe® Stereotactic SystemSTarFix™Platform	Microscope Navigation: Zeiss, LeicaUltrasound Navigation: Aloka and SonositeMedtronic O-armStereotactic Frame Systems: Fischer ZD,Fischer RM, Integra CRW and LeksellNexframe® Stereotactic SystemSTarFix™Platform
View (Display)Features	Ultrasound Video In, Ultrasound Overlay,3D, 2D Anatomic Orthogonal, Trajectory 1and 2, Target Guidance, TrajectoryGuidance, Probes Eye, Look Ahead,Microscope Injection, Video Input	Ultrasound Video In, Ultrasound Overlay,3D, 2D Anatomic Orthogonal, Trajectory 1and 2, Target Guidance, TrajectoryGuidance, Probes Eye, Look Ahead,Microscope Injection, Video Input
Software Interface(GUI)	Blue style with chronological next/backtask flow at the top of the screen. Imagecontrols on the left. Planning informationon the right.	Blue style with chronological next/backtask flow at the top of the screen. Imagecontrols on the left. Planning informationon the right.
ProgrammingLanguage	C++	C++
Scanner InterfaceTechnology (toimaging devices)	Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export	Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export
LocalizationTechnology	Optical (infra-red)Electromagnetic	Optical (infra-red)Electromagnetic