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

Device Description

The StealthStation System, with Synergy Cranial v2.2.7 software helps guide surqeons during cranial surgical procedures such as biopsies, tumor resections, and shunt placements. The Synergy Cranial v2.2.7 software works in conjunction with an Image Guided System (IGS) which consists of clinical software, surqical instruments, a referencing system and platform/computer hardware. Image quidance, 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. Synergy Cranial v2.2.7 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

Here's a breakdown of the acceptance criteria and study information for the StealthStation System with Synergy Cranial Software, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance
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 Data Provenance

The document does not explicitly state a numerical "sample size" for the test set in terms of cases or patients. Instead, it describes:

Test Setup: "an anatomically representative phantom." This suggests a single or very limited number of phantoms were used to test accuracy.
Data Provenance: The testing was conducted "in laboratory and simulated use settings." This indicates a retrospective and simulated provenance, not based on real patient data from a specific country.

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

The document does not mention the use of experts to establish ground truth for the test set. The ground truth for accuracy testing on a phantom would typically be established by the precise design and known dimensions of the phantom itself, and the accurate measurement tools used during the test.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. Since the performance testing was based on an anatomically representative phantom and direct measurements of positional and angular error, adjudication by human experts (as would be typical for image interpretation tasks) was not applicable or performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document does not describe any human reader studies or a comparison of human reader performance with and without AI assistance. The testing focuses solely on the device's inherent accuracy in a simulated environment.

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

Yes, a standalone performance evaluation was conducted. The document states that the testing demonstrated the system's "performance in 3D positional accuracy" and "trajectory angle accuracy." These are measurements of the algorithm/system's precision in guiding instruments, independent of a human's interpretation or decision-making. The device, an Image Guided System (IGS), inherently functions as a standalone guidance system, providing objective measurements to the surgeon.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used for the performance testing was based on the known physical properties and precise measurements of an anatomically representative phantom. This is a form of engineered or objective ground truth, not derived from subjective expert consensus, pathology, or patient outcomes.

8. The Sample Size for the Training Set

The document does not provide any information about the sample size used for a training set. This is typical for a medical device cleared via 510(k) where the focus is on substantial equivalence to a predicate device and performance validation, rather than the development and training of a novel AI algorithm from a large dataset. The Synergy Cranial software is likely a refined version or update to existing navigation software, rather than a de-novo AI model requiring extensive training data.

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

As no training set is described, there is no information on how its ground truth would have been established.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract design featuring three stylized human profiles facing to the right, with flowing lines beneath them.

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

June 11, 2015

Medtronic Navigation, Inc. Ms. Kaye E. Waite Senior Regulatory Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K150216

Trade/Device Name: StealthStation System with Synergy Cranial Software Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: May 11, 2015 Received: May 12, 2015

Dear Ms. 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. 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

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150216

Device Name

StealthStation System with 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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510(k) Summary

June 10, 2015

Medtronic Navigation, Inc. l. Company: 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200 Fax Number: 720-890-3500
- Kaye E. Waite Contact: Senior Requlatory Affairs Specialist Telephone Number: 720-890-3200 Fax Number: 720-890-3500
ll. Proprietary Trade Name: StealthStation System with Synergy Cranial Software
.............................................................................................................................................................................. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
Classification: Class II, Stereotaxic Instrument IV.
V. Product Code: HAW

VI. Product Description

VII. Indications for Use

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.

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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

VIII. Summary of the Technological Characteristics

Item	Subject Device (Synergy Cranial)	Predicate Device (Mach Cranial)StealthStation System Update -K050438
Intended Use	The StealthStation® System, with Synergy®Cranial software is designed as an aid forprecisely locating anatomical structures ineither open or percutaneous neurosurgicalprocedures.	The StealthStation® System is intended as anaid for precisely locating anatomical structuresin either open or percutaneous procedures.
Indications forUse	The StealthStation System, with SynergyCranial software, is intended as an aid forprecisely locating anatomical structures ineither open or percutaneous neurosurgicalprocedures. The system is indicated for anymedical condition in which reference to a rigidanatomical structure can be identified relativeto images of the anatomy.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 is intended as anaid for precisely locating anatomical structuresin either open or percutaneous procedures.The StealthStation® System is indicated forany medical condition in which the use ofstereotactic surgery may be appropriate, andwhere reference to a rigid anatomicalstructure, such as the skull, a long bone, orvertebra, can be identified relative to a CT orMR based model, fluoroscopy images, ordigitized landmarks of the anatomy.For the optical-based and EM-based system,example procedures include, but are notlimited to:- 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
SystemAccuracyRequirement	The System has demonstrated accuracy with	The System has demonstrated accuracy with
	a mean positional error of 2mm and mean	a mean positional error of 2mm and mean
	trajectory error of 2 degrees	trajectory error of 2 degrees

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Imaging Modalities	X-Ray based,MR basedNuclear Medicine based
Registration Features	Exam-to-Exam RegistrationPatient Registration
Planning Features	Plan Entry and Target Selection3D Model BuildingAdvanced Visualization
Medical Device Interfaces	Microscope Navigation: Zeiss, LeicaUltrasound Navigation: Aloka and SonositeMedtronic O-arm
View (Display) Features	Ultrasound Video In, Ultrasound Overlay, 3D,Anatomic Orthogonal, Trajectory 1 and 2,Target Guidance, 2D Trajectory Guidance,Probes Eye, Look Ahead, MicroscopeInjection, Video Input
Software Interface (GUI)	Blue style with chronological next/back taskflow at the top of the screen. Image controlson the left. Planning information on the right.
Programming Language	C++
Localization Technology	Optical (infra-red)Electromagnetic

IX. Identification of Legally Marketing Device (Predicate Device) StealthStation System Update (K050438)

Discussion of the Performance Testing X.

The following table summarizes the testing conducted on the StealthStation System with Synergy Cranial v2.2.7 software:

Description

Under representative worst-case configuration, the StealthStation® System with Synergy 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 an anatomically representative phantom and utilizing a subset of system components and features that represent the worst-case combination of all potem components. The test configuration 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.

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:

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Description

Software Development Life Cycle

Software Risk Assessment

Software Configuration Management and Version Control

Design verification and validation was performed using the StealthStation System with Synerqy Cranial v2.2.7 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..

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 Synergy Cranial v2.2.7 software should perform as intended in the specified use conditions. The non-clinical data demonstrate that the StealthStation System with Synergy Cranial 2.2.7 software performs comparably to the predicate device for the same intended use.

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).