The StealthStation™ System, with StealthStation™ Cranial Software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical 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 skull, 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):

· Tumor resections
General ventricular catheter placement
· Pediatric ventricular catheter placement
· Depth electrode, lead, and probe placement
· Cranial biopsies

Device Description

The StealthStation™ Cranial Software v1.3.0 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. During surgery, positions of specialized surgical instruments are continuously updated on these images either by optical tracking or electromagnetic tracking.

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.

The changes to the currently cleared StealthStation S8 Cranial Software are as follows:

. Addition of an optional image display that allows the user to see through outer layers to increase the visibility of other models.
. Update the imaging protocol to support overlapping slices.
. Minor changes to the software were made to address user preferences and to fix minor anomalies.

AI/ML Overview

The provided document is a 510(k) premarket notification summary for Medtronic's StealthStation Cranial Software v1.3.0. It describes the device, its intended use, and a comparison to a predicate device, along with performance testing.

Here's an analysis to address your specific questions:

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

Acceptance Criteria	Reported Device Performance
System Accuracy Requirements
3D Positional Accuracy: mean error ≤ 2.0 mm	Mean error ≤ 2.0 mm
Trajectory Angle Accuracy: mean error ≤ 2.0 degrees	Mean error ≤ 2.0 degrees

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify a sample size (e.g., number of cases or images) for the performance testing. It states that the 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."

Regarding data provenance, the testing was conducted in "laboratory and simulated use settings" using "anatomically representative phantoms." This indicates that the data was generated specifically for testing purposes, likely in a controlled environment, rather than being derived from real patient scans. The country of origin for the data is not specified, but the applicant company, Medtronic Navigation Inc., is based in Louisville, Colorado, USA. The testing appears to be prospective in nature, as it was specifically carried out to demonstrate equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document does not mention the involvement of human experts for establishing ground truth for the performance testing. The accuracy measurements (3D positional and trajectory angle) are typically derived from physical measurements against known ground truth (e.g., phantom dimensions, known instrument positions) in the context of navigation systems, not by expert consensus on image interpretation.

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

Not applicable. The performance testing described is objective measurement against physical phantoms, not subjective assessment by experts requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document explicitly states: "Clinical testing was not considered necessary prior to release as this is not new technology." This device is an image-guided surgery system software, not an AI-assisted diagnostic tool that would typically undergo MRMC studies. The changes in this version (v1.3.0) are described as "minor changes to the software were made to address user preferences and to fix minor anomalies" and "Addition of an optional image display that allows the user to see through outer layers," suggesting incremental updates rather than a fundamentally new AI algorithm.

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

Yes, the performance testing was effectively "standalone" in the sense that the system's accuracy was measured against a known physical ground truth (phantoms) rather than evaluating human performance with the system. The reported accuracy metrics describe the device's inherent precision in tracking and navigation, independent of user interaction during the measurement process itself.

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

The ground truth used was based on known physical properties of anatomically representative phantoms. This means that a physical phantom with precisely known dimensions and features was used, and the device's ability to accurately locate points and trajectories within that known physical structure was measured. This is a common and appropriate method for validating the accuracy of surgical navigation systems.

8. The sample size for the training set

Not applicable. This device, as described, is a software for image-guided surgery, not an AI/ML model that would typically have a "training set" in the context of deep learning. The changes are described as minor software updates and an optional display feature, not a new algorithm requiring a training phase from data.

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

Not applicable, as there is no mention of a training set for an AI/ML model in this submission.

Summary

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June 3, 2020

Medtronic Navigation Inc. Amelia Striegel Senior Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K201175

Trade/Device Name: StealthStation Cranial Software v1.3.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: April 30, 2020 Received: May 1, 2020

Dear Amelia Striegel:

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 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

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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 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,

Adam D. Pierce Acting 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)

K201175

Device Name StealthStation™ Cranial Software v1.3.0

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):

· Tumor resections
General ventricular catheter placement
· Pediatric ventricular catheter placement
· Depth electrode, lead, and probe placement
· Cranial biopsies

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)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

cription 65c (Part 21 CFR 601 Subpart D)

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

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510(k) Summary

30 April 2020

l. Company: Medtronic Navigation. Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200
- Amelia Striegel (Primary) Contact: Senior Regulatory Affairs Specialist Telephone Number: 720.890.2528 Fax Number: 720.890.3500

K. Elizabeth Waite Regulatory Affairs Manager Telephone number: 720.890.2182 Fax: 720.890.3500 Email: elizabeth.waite@medtronic.com

Proprietary Trade Name: StealthStation™ Cranial Software v1.3.0 II.
lll. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
IV. Classification: Class II, Stereotaxic Instrument
V. Product Codes: HAW
VI. Predicate Device

510(k): K162309 Device name: StealthStation S8 Cranial Software v1.0.0 Manufacturer: Medtronic Navigation, Inc.

VII. Product Description

The changes to the currently cleared StealthStation S8 Cranial Software are as follows:

. Addition of an optional image display that allows the user to see through outer layers to increase the visibility of other models.

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. Update the imaging protocol to support overlapping slices.
. Minor changes to the software were made to address user preferences and to fix minor anomalies.

VIII. Indications for Use

The StealthStation™ System, with StealthStation™ Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical 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 skull, 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):

· Tumor resections
General ventricular catheter placement
Pediatric ventricular catheter placement
· Depth electrode, lead, and probe placement
· Cranial biopsies

IX. Comparison of the Technological Characteristics

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Identification of Legally Marketed Devices X.

StealthStation S8 Cranial Software v1.0.0 (K162309)

XI. Discussion of the Performance Testing

The following table summarizes the testing conducted on the StealthStation Cranial Software v1.3.0

Description

Under representative worst-case configuration, the StealthStation S8 System with StealthStation Cranial Software v1.3.0 has demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm and in trajectory angle accuracy with a mean error of ≤ 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. Software verification and validation testing for each requirement specification. 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

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Design verification and validation was performed using the StealthStation S8 System with StealthStation Cranial Software v1.3.0 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.

Clinical testing was not considered necessary prior to release as this is not new technology.

XII. Conclusions

The StealthStation Cranial Software v1.3.0 has been shown through testing and comparison to be substantially equivalent to the identified predicate device.

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).

Feature	StealthStation CranialSoftware v1.3.0 (SubjectDevice)	StealthStation S8 Cranialsoftware v1.0.0 (PredicateDevice; K162309)
Intended Use	The StealthStationTM System, withStealthStationTM Cranial Software isdesigned as an aid for locatinganatomical structures in either openor percutaneous neurosurgicalprocedures.	The StealthStation® System, withStealthStation® Cranial software isdesigned as an aid for locatinganatomical structures in either openor percutaneous neurosurgicalprocedures.
Feature	StealthStation CranialSoftware v1.3.0 (SubjectDevice)	StealthStation S8 Cranialsoftware v1.0.0 (PredicateDevice; K162309)
Indications forUse	The StealthStation™ System, withStealthStation™ Cranial Software,is intended as an aid for locatinganatomical structures in either openor percutaneous neurosurgicalprocedures. Their use is indicatedfor any medical condition in whichthe use of stereotactic surgery maybe appropriate, and wherereference to a rigid anatomicalstructure, such as the skull, can beidentified relative to images of theanatomy.	The StealthStation™ System, withStealthStation™ Cranial software, isintended as an aid for locatinganatomical structures in either openor percutaneous neurosurgicalprocedures. Their use is indicatedfor any medical condition in whichthe use of stereotactic surgery maybe appropriate, and wherereference to a rigid anatomicalstructure, such as the skull, can beidentified relative to images of theanatomy.
	This can include, but is not limitedto, the following cranial procedures(including stereotactic frame-basedand stereotactic frame alternatives-based procedures):• Tumor resections• General ventricular catheterplacement• Pediatric ventricular catheterplacement• Depth electrode, lead, and probeplacement• Cranial biopsies	This can include, but is not limitedto, the following cranial procedures(including stereotactic frame-basedand stereotactic frame alternatives-based procedures):• Tumor resections• General ventricular catheterplacement• Pediatric ventricular catheterplacement• Depth electrode, lead, and probeplacement• Cranial biopsies
SystemAccuracyRequirements	Under representative worst-caseconfiguration, the StealthStation S8System with StealthStation CranialSoftware v1.3.0, has demonstratedperformance in 3D positionalaccuracy with a mean error ≤ 2.0mm and in trajectory angleaccuracy with a mean error ≤ 2.0degrees.	Under representative worst-caseconfiguration, the StealthStation S8System with StealthStation Cranialv1.0.0 Software, has demonstratedperformance in 3D positionalaccuracy with a mean error ≤ 2.0mm and in trajectory angleaccuracy with a mean error ≤ 2.0degrees.
ImagingModalities	X-Ray based, MR based,Nuclear Medicine based	X-Ray based, MR based,Nuclear Medicine based
View (Display)Features	Ultrasound Video In, UltrasoundOverlay, 3D, 2D AnatomicOrthogonal, Trajectory 1 and 2,Target Guidance, TrajectoryGuidance, Probes Eye, LookAhead, Microscope Injection, VideoInput, Endoscopic	Ultrasound Video In, UltrasoundOverlay, 3D, 2D AnatomicOrthogonal, Trajectory 1 and 2,Target Guidance, TrajectoryGuidance, Probes Eye, LookAhead, Microscope Injection, VideoInput, Endoscopic
Feature	StealthStation CranialSoftware v1.3.0 (SubjectDevice)	StealthStation S8 Cranialsoftware v1.0.0 (PredicateDevice; K162309)
Exam-to-ExamRegistrationFeatures	Identity Merge Registration, ManualMerge Registration and AutomaticMerge Registration	Identity Merge Registration, ManualMerge Registration and AutomaticMerge Registration
PatientRegistrationFeatures	PointMergeTM registration (referredto as Landmark registrations),TracerTM registration, Touchregistration (previously Touch-N-GoTM), StealthAiRTM registration, O-armTM registration, Mechanicalbased registrations (StereotacticLocalizer Registration and StarFixTMBone Anchor Registration)	PointMerge® registration (referredto as Landmark registrations),TracerTM registration, Touchregistration (previously Touch-N-GoTM), StealthAiR® registration, O-arm® registration, Mechanicalbased registrations (StereotacticLocalizer Registration and StarFixTMBone Anchor Registration)
PlanningFeatures	Plan Entry and Target Selection3D Model BuildingAdvanced VisualizationCreate Patient Based AnatomicalCoordinate SpaceStereotactic Frame SettingsBrain Atlas: Schaltenbrand-WahrenAtlas with Talairach GridSTarFixTM DesignerAnnotations	Plan Entry and Target Selection3D Model BuildingAdvanced VisualizationCreate Patient Based AnatomicalCoordinate SpaceStereotactic Frame SettingsBrain Atlas: Schaltenbrand-WahrenAtlas with Talairach GridSTarFixTM DesignerAnnotations
Medical DeviceInterfaces	Microscope Navigation: Zeiss, LeicaUltrasound Navigation: Aloka andSonositeMedtronic O-armTMStereotactic Frame Systems:Fischer ZD, Fischer RM, IntegraCRW and Elekta LeksellNexframeTM Stereotactic SystemSTarFixTMPlatform SystemStealth Midas Rex MR8StealthStation Autoguide	Microscope Navigation: Zeiss, LeicaUltrasound Navigation: Aloka andSonositeMedtronic O-arm®Stereotactic Frame Systems:Fischer ZD, Fischer RM, IntegraCRW and Elekta LeksellNexframe® Stereotactic SystemSTarFixTMPlatform System
CompatibleMedtronicOpticalInstrumentation	Medtronic instruments tracked viaoptical markers or LEDs located oninstrument and patient trackers viathe optical localizing system.	Medtronic instruments tracked viaoptical markers or LEDs located oninstrument and patient trackers viathe optical localizing system.
CompatibleMedtronic EMInstrumentation	Medtronic instruments tracked viaelectromagnetic localizationtechnology located within theinstrument and patient trackers	Medtronic instruments tracked viaelectromagnetic localizationtechnology located within theinstrument and patient trackers
Feature	StealthStation CranialSoftware v1.3.0 (SubjectDevice)	StealthStation S8 Cranialsoftware v1.0.0 (PredicateDevice; K162309)
SoftwareInterface(GUI)	Black and gray style with proceduretask overview in left menu optionand next/back task flow at bottom ofthe screen. Software controls forimages, planning and instrumentmanagement are contained in aright side bar.	Black and gray style with proceduretask overview in left menu optionand next/back task flow at bottom ofthe screen. Software controls forimages, planning and instrumentmanagement are contained in aright side bar.
ProgrammingLanguage	C++	C++
ScannerInterfaceTechnology (toimagingdevices)	Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export	Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export
OpticalTechnology	Manufacturer: Northern Digital Inc.Localizer: Vega	Manufacturer: Northern Digital Inc.Localizer: Vega
ElectromagneticTechnology	Manufacturer: MedtronicNavigation, Inc.Localizer: AxiEM IIIEmitter Types: Side, Flat	Manufacturer: MedtronicNavigation, Inc.Localizer: AxiEM IIIEmitter Types: Side, Flat