Synergy Cranial v2.2.9:
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. 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

StealthStation Cranial Software v3.1.4:
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 Medtronic Navigation, Inc. StealthStation Cranial Software (v3.1.4) and Synergy Cranial Software (v2.2.9) are image-guided surgery (IGS) systems intended to aid in precisely locating anatomical structures during neurosurgical procedures.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for both software versions are related to system accuracy in 3D positional and trajectory angle measurements.

Acceptance Criteria (Synergy Cranial v2.2.9 & StealthStation Cranial v3.1.3/v3.0)	Reported Device Performance (Synergy Cranial v2.2.9)	Reported Device Performance (StealthStation Cranial v3.1.3/v3.0)
System Accuracy:
3D positional accuracy: mean error ≤ 2.0 mm	1.29 mm	1.27 mm
Trajectory angle accuracy: mean error ≤ 2.0 degrees	0.87 degrees	1.02 degrees

Note: The document refers to "StealthStation Cranial v3.1.3" and also "StealthStation Cranial v3.0 Software" in the testing section for the newer version's accuracy. Assuming v3.1.3 is the subject device and v3.0 is a close predecessor or the system version used for the test. The "v3.1.4" in the 510(k) letter is likely a minor update from v3.1.3, and the reported performance for v3.1.3 is considered representative.

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

The document does not explicitly state the sample size (number of patients or phantom configurations) used for the quantitative accuracy testing (test set). It mentions:

"Under representative worst-case configuration"
"utilizing a subset of system components and features that represent the worst-case combinations of all potential system components."
"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."

Data Provenance: The data appears to be prospective as it was generated through laboratory and simulated use settings with "anatomically representative phantoms." The country of origin is not explicitly stated, but given Medtronic Navigation, Inc. is located in Louisville, Colorado, USA, it's highly probable the testing was conducted in the USA.

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

The document indicates that the accuracy was determined using "anatomically representative phantoms." This implies that the ground truth for positional and angular accuracy was engineered and precisely measured within a controlled phantom environment, rather than established by human experts interpreting clinical data. Therefore, human experts were likely involved in designing and validating the phantom setup and measurement methodologies, but not in directly establishing ground truth from patient data. The qualifications of these individuals are not specified but would typically be engineers, physicists, or metrology specialists.

4. Adjudication Method for the Test Set

Given that the ground truth was established through a designed phantom and precise measurements, an adjudication method for human interpretation is not applicable here. The measurements are objective and quantitative.

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

No MRMC comparative effectiveness study was mentioned for human readers improving with AI vs. without AI assistance. The device is a surgical navigation system, aiding in real-time guidance, not an AI-assisted diagnostic tool that would typically undergo MRMC studies.

6. Standalone (i.e., algorithm only without human-in-the-loop performance)

Yes, a standalone performance was done for the system's accuracy. The reported positional and trajectory angle errors are measures of the system's inherent accuracy, independent of a specific human-in-the-loop scenario. The study describes "Design verification and validation was performed using the StealthStation Cranial software in laboratory and simulated use settings."

7. The Type of Ground Truth Used

The ground truth used was engineered truth derived from precisely measured anatomical phantoms. This is a highly controlled and quantitative method, suitable for measuring the accuracy of a navigation system.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI/machine learning model. The device is referred to as "software" for an Image Guided System (IGS), which typically relies on established algorithms for image processing, registration, and tracking, rather than deep learning models that require large training datasets with ground truth labels in the conventional sense. The "training" for such a system would involve rigorous formal verification and validation of these algorithms.

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

As noted above, the concept of a "training set" and its associated ground truth, as typically applied to AI/machine learning, does not appear to be directly applicable to the description of this device's development as presented in the 510(k) summary. The development involved "Software verification and validation testing for each requirement specification" and "System integration performance testing for cranial surgical procedures using anatomical phantoms," suggesting traditional software engineering and testing methodologies rather than machine learning training.

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). The logo consists of two parts: a symbol representing the Department of Health & Human Services on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The FDA text is in blue, with "FDA" in a solid blue square and the rest of the text in a lighter blue.

June 10, 2022

Medtronic Navigation, Inc. Silver Wirth Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K221087

Trade/Device Name: Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: April 11, 2022 Received: April 13, 2022

Dear Silver Wirth:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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,

Adam D. Pierce, Ph.D. 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) K221087

Device Name

Synergy Cranial v2.2.9 (9733763); StealthStation Cranial v3.1.4 (9735585)

Indications for Use (Describe)

Synergy Cranial v2.2.9:

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. 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

StealthStation Cranial Software v3.1.4:

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 stereotactivesbased 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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

April 11, 2022

l. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200 Fax Number: 720-890-3500
- Contact: Silver Wirth Regulatory Affairs Specialist Telephone Number: 720-890-3200

Olga Lewis (Alternate) Senior Regulatory Affairs Manager Telephone Number: 720-890-3200

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;
- K190672, StealthStation Synergy Cranial S7 Software v2.2.8, StealthStation Cranial Software v3.1.1

VII. Product Description

VIII. Indications for Use

Cranial Software v2.2.9

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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 v3.1.3

The StealthStation System, with Station 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

IX. Summary of the Technological Characteristics

StealthStation Cranial Software v2.2.9 as compared to Predicate Device

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K221087 Page 4 of 7

StealthStation Cranial Software v3.1.3 as compared to Predicate Device

Item	Subject Device	Predicate Device
	StealthStation System with Cranial v3.1.3Software	K190672 StealthStation System withStealthStation Cranial v3.1.1 Software
Intended Use	The StealthStation System, withStealthStation Cranial software is designedas an aid for locating anatomicalstructures in either open or percutaneousneurosurgical procedures.	The StealthStation System, withStealthStation Cranial software is designedas an aid for locating anatomical structuresin either open or percutaneousneurosurgical procedures.
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 anatomical	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 anatomical
	Subject Device	Predicate Device
	StealthStation System with Cranial v3.1.3	K190672 StealthStation System with
Item	Software	StealthStation Cranial v3.1.1 Software
	structure can be identified relative to	structure can be identified relative to
	images of the anatomy.	images 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	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 Placement	- Thalamotomies/Pallidotomies- Pituitary Tumor Removal- CSF Leak Repair- Pediatric Ventricular Catheter Placement- General Ventricular Catheter Placement
	The user should consult the "NavigationalAccuracy" section of the User Manual toassess if the accuracy of the system issuitable to their needs.	The user should consult the "NavigationalAccuracy" section of the User Manual toassess if the accuracy of the system issuitable to their needs.
System Accuracy	Under representative worst-case	Under representative worst-case
Requirement	configuration, 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.	configuration, 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 ValuesPosition Error - 1.27 mmTrajectory Error - 1.02 degrees	Specific Mean Accuracy ValuesPositional Error – 1.16 mmTrajectory Error – 0.41 degrees
Imaging Modalities	X-Ray based,MR basedNuclear Medicine based	X-Ray based,MR basedNuclear Medicine based
RegistrationFeatures	Exam-to-Exam Registration: IdentityMerge Registration, Manual MergeRegistration and Automatic MergeRegistration.	Exam-to-Exam Registration: IdentityMerge Registration, Manual MergeRegistration and Automatic MergeRegistration.
Item	Subject Device	Predicate Device
	StealthStation System with Cranial v3.1.3	K190672 StealthStation System with
Item	Software	StealthStation Cranial v3.1.1 Software
	Patient Registration: PointMerge	Patient Registration: PointMerge
	registration, Tracer registration, Touch-N-	registration, Tracer registration, Touch-N-
	Go registration, StealthAiR registration, O-	Go registration, StealthAiR registration, O-
	arm registration, Stereotactic Localizer	arm registration, Stereotactic Localizer
	Registration and StarFix Bone Anchor	Registration and StarFix Bone Anchor
	Registration	Registration
Planning Features	Plan Entry and Target Selection	Plan Entry and Target Selection
	3D Model Building	3D Model Building
	Advanced Visualization	Advanced Visualization
	Create Patient Based Anatomical	Create Patient Based Anatomical
	Coordinate Space	Coordinate Space
	Stereotactic Frame Settings	Stereotactic Frame Settings
	Brain Atlas: Schaltenbrand-Wahren Atlas	Brain Atlas: Schaltenbrand-Wahren Atlas
	with Talairach Grid	with Talairach Grid
	STarFix Designer	STarFix Designer
	Annotations	Annotations
Medical Device	Microscope Navigation: Zeiss, Leica	Microscope Navigation: Zeiss, Leica
Interfaces	Ultrasound Navigation: Aloka and Sonosite	Ultrasound Navigation: Aloka and Sonosite
	Medtronic O-arm	Medtronic O-arm
	Stereotactic Frame Systems: Fischer ZD,	Stereotactic Frame Systems: Fischer ZD,
	Fischer RM, Integra CRW and Leksell	Fischer RM, Integra CRW and Leksell
	Nexframe® Stereotactic System	Nexframe® Stereotactic System
	STarFix™Platform	STarFix™Platform
View (Display)	Ultrasound Video In, Ultrasound Overlay,	Ultrasound Video In, Ultrasound Overlay,
Features	3D, 2D Anatomic Orthogonal, Trajectory 1	3D, 2D Anatomic Orthogonal, Trajectory 1
	and 2, Target Guidance, Trajectory	and 2, Target Guidance, Trajectory
	Guidance, Probes Eye, Look Ahead,	Guidance, Probes Eye, Look Ahead,
	Microscope Injection, Video Input	Microscope Injection, Video Input
Software Interface	Blue style with chronological next/back	Blue style with chronological next/back
(GUI)	task flow at the top of the screen. Image	task flow at the top of the screen. Image
	controls on the left. Planning information	controls on the left. Planning information
	on the right.	on the right.
Programming	C++	C++
Language
Scanner Interface	Network Connectivity	Network Connectivity
Technology (to	CD, DVD, USB	CD, DVD, USB
imaging devices)	DICOM Import	DICOM Import
	DICOM Export	DICOM Export
Localization	Optical (infra-red)	Optical (infra-red)
Technology	Electromagnetic	Electromagnetic
	Mechanical based stereotactic	Mechanical based stereotactic

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K221087 Page 5 of 7

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X. Identification of Legally Marketing Devices

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K190672, StealthStation Synergy Cranial S7 Software v2.2.8, StealthStation Cranial Software v3.1.1

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 trajectory 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).