The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System 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, a long bone, or vertebra, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

Device Description

The StealthStation® System includes hardware and software that enables realtime surgical navigation using radiological patient images. The navigation system creates a translation map between points in the patient anatomy and the corresponding points on radiologic images of the patient. Once this map is established (through a process called registration), the software can display the relative position of a tracked instrument to a representation of the patient's anatomy. In this way the images can help guide the surgeon's planning and approach. Prior to operating, the surgeon may then create, store, and simulate progression along one or more surgical trajectories. As an aid to visualization, the surgeon may also create and manipulate one or more 2D or 3D models of the anatomy. During surgery, the system tracks the position of specialized surgical instruments in or on the patient anatomy and continuously updates the instrument position on these images either by optical tracking or electromagnetic tracking.

The operating system is software that controls the execution of programs, and that provides services such as resource allocation, scheduling, input/output control, and data management. This includes managing computer system hardware and software resources and providing a common set of services for software applications to interface with computing hardware.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the StealthStation® System, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

This 510(k) is for a minor modification to an existing device (predicate device K050438), specifically a change in the operating system from a proprietary Linux (GemOS) to Debian Linux. The rationale presented is that "No changes have been made to the StealthStation® operating principle or hardware due to the change to the operating system." Therefore, the primary acceptance criteria revolve around ensuring that this operating system change does not negatively impact the established performance of the predicate device and that the new system functions as expected.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Aspect	Predicate Device K050438 Performance (as reference)	Subject Device (StealthStation® System with Debian Linux) Performance	Notes
Functional Verification	Not explicitly stated as a separate criterion in predicate's summary, but implied by original clearance.	"Verification successful, operating system fulfills all product requirements"	This criterion ensures the new operating system and its infrastructure correctly meet all defined product requirements.
Regression Verification	Not explicitly stated, implied by original clearance.	"Verification successful, unchanged but vulnerable portions of the product have not been adversely affected."	This criterion is crucial for changes to existing devices, ensuring that the new operating system does not introduce unintended negative effects on previously validated functionalities or components.
Validation (End-User Needs)	Not explicitly stated, implied by original clearance.	"All tests passed, which demonstrates that the product meets the needs of the end user."	This criterion confirms that despite the underlying operating system change, the overall system still effectively serves the intended purpose and meets the requirements of the clinicians who will use it. This often involves user testing scenarios to confirm usability and performance in a relevant context.
System Accuracy	"Stand-alone accuracy was reported in K050438" (performance deemed unchanged).	Identical to predicate (i.e., performance reported in K050438).	The 510(k) states that accuracy will not change, as the operating system change does not affect the core tracking and image guidance principles. The specific accuracy values for K050438 are not provided in this summary but are referenced as the benchmark. The study for K133444 implicitly relies on the continued validity of K050438's accuracy data.
Intended Use	Identical to K050438	Identical to K050438	The change in operating system does not alter the indications for use of the device.
Operating Principle (Tracking)	Identical to K050438 (Optical (infra-red), EM)	Identical to K050438	The underlying tracking technology remains unchanged.
Control Mechanism (Hardware)	Identical to K050438 (Digitizer/Localizer, Computer, Reference Frames)	Identical to K050438	The physical hardware components and their control mechanisms are not altered by the operating system change.

Study Details for StealthStation® System (K133444)

The study described here is primarily focused on verification and validation (V&V) of a software update (operating system change), rather than a de novo clinical trial demonstrating efficacy of the device itself. The core performance of the device (e.g., accuracy) is established by the predicate device (K050438).

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical sample size of "cases" or "patients." The testing involved verification and validation activities on the software system itself. Given the nature of an operating system update, the "test set" would refer to a comprehensive suite of software tests, system configurations, and simulated or actual usage scenarios.
- Data Provenance: Not applicable in the context of patient data for this specific 510(k). The data comes from internal testing and verification activities of the software and system.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the summary. For software V&V, "ground truth" would be the expected behavior and output of the system according to its design specifications. This is typically established by design documentation and testing protocols, not necessarily clinical expert consensus in the way a diagnostic AI model would require. Software engineers and testers are the "experts" in this context, but their number and specific qualifications are not detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the context of clinical adjudication for this type of software V&V testing. Software testing typically involves automated tests, manual testing by quality assurance engineers, and review against specifications. There's no mention of a "2+1" or similar adjudication process.
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, an MRMC comparative effectiveness study was not done. This 510(k) is for a surgical navigation system, not a diagnostic AI device that assists human readers in interpreting images. The device itself is an aid for surgeons, and this submission focuses on a technical update, not a clinical effectiveness study.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Yes, in essence, standalone performance was assessed in terms of "System Accuracy" referenced from the predicate device (K050438). While this 510(k) does not provide new standalone accuracy data, it relies on the existing standalone accuracy data from K050438. The submission implicitly argues that since the operating system change doesn't affect the core algorithms or hardware, the standalone accuracy performance remains the same. The "functional" and "regression" verification also assess the system's performance in a standalone context (i.e., the software and hardware working correctly).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the core functional accuracy of the navigation system itself (as established by the predicate K050438), the ground truth would typically be highly precise physical measurements (e.g., using a coordinate measuring machine (CMM) or other calibrated metrology equipment) to compare the system's reported position to the true physical position of a tracked instrument.
- For the current submission (K133444) focusing on the OS update, the "ground truth" for the verification and validation tests would be:
  - Product Requirements/Specifications: The system is expected to perform according to its documented requirements.
  - Expected Software Behavior: The new OS environment should not alter the functionality, stability, or performance of the application software compared to the previous OS.
  - End-User Needs: The system should remain usable and effective for surgical navigation.
The sample size for the training set:
- Not applicable. This device is a surgical navigation system, not a machine learning or AI model that requires a "training set" in the conventional sense. The "software" being updated is the operating system, which is a foundational component, not an algorithm trained on data.
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of this device.

Summary

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510(k) Summary

January 2, 2014

K133444 JUL 2 5 2014

I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200 Fax Number: 720-890-3500
- Contact: Kaye Waite Regulatory Affairs Specialist Telephone Number: 720-890-2182 Fax Number: 720-890-3709
Proprietary Trade Name: StealthStation® System II.
III. Common Name: Stereotaxic Instrument
Classification Name: Stereotaxic Instrument (21 CFR 882.4560) IV.
V. Classification: Class II (21 CFR 882.4560)
VI. Product Code: HAW, OLO

VII. Product Description:

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VIII. Indications for Use:

IX. Identification of Legally Marketing Devices (Predicate Devices)

StealthStation® System Update (K050438) .

X. Comparison of the Technological Characteristics:

The subject of this 510(k) is the StealthStation® System with an off-the-shelf operating system, which represents a minor modification to the StealthStation® System predicate device (K050438). The difference between the predicate and the subject device is the change to the operating system from proprietary to off-the-shelf. No changes have been made to the StealthStation® operating principle or hardware due to the change to the operating system.

Item	Subject Devices	Predicate Devices
Indications for Use	The StealthStation® System is intended asan aid for precisely locating anatomicalstructures in either open or percutaneousprocedures. The StealthStation® System isindicated for any medical condition inwhich the use of stereotactic surgery maybe appropriate, and where reference to arigid anatomical structure, such as theskull, a long bone, or vertebra, can beidentified relative to a CT or MR basedmodel, fluoroscopy images, or digitizedlandmarks of the anatomy.	StealthStation System Update - K050438The StealthStation® System is intended as anaid for precisely locating anatomicalstructures in either open or percutaneousprocedures. The StealthStation® System isindicated for any medical condition in whichthe use of stereotactic surgery may beappropriate, and where reference to a rigidanatomical structure, such as the skull, a longbone, or vertebra, can be identified relative toa CT or MR based model, fluoroscopyimages, or digitized landmarks of theanatomy.Includes a list of clinical procedures.
Operating Principle(Tracking Method)	Identical	StealthStation System Update - K050438Optical (infra-red)EM
Control Mechanism(Hardware)	Identical	StealthStation System Update - K050438Digitizer/LocalizerComputerReference Frames

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System Accuracy	Identical	StealthStation System Update - K050438Stand-alone accuracy was reported inK050438 and will not change with the updateto the operating system.
Operating System	Debian Linux	StealthStation System Update - K050438Linux (GemOS)

.. The subject devices have the same intended use and technological characteristics as the predicate devices.

XI. Discussion of the Performance Testing

Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. The following table summarizes the performance testing completed:

Test	Description	Result
Verification(Functional)	Provides confirmation that the design and implementation of the operating system and all operating system infrastructure correctly fulfills all product requirements	Verification successful, operating system fulfills all product requirements
	Verification(Regression)	Provides confidence that after a change to a product, unchanged but vulnerable portions of the product have not been adversely affected.
Validation		Ensures that the product meets the needs of the end user.

All tests passed, which demonstrates that the performance of the subject operating system is equivalent to that of the predicate device.

XII. Conclusions

The StealthStation® System with the Debian operating system has been shown through comparison and testing to be substantially equivalent to the identified predicate devices.

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Public Health Service

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

July 25, 2014

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

Re: K133444

Trade/Device Name: StealthStation® System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, OLO Dated: June 26, 2014 Received: June 27, 2014

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Kaye Waite

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

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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No, 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133444

Device Name StealthStation System

Indications for Use (Describe)

The StealthStation System is intended as an aid for precisely locating an either open or perculancous procedures. The SteathStation System is indical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as long bone, or vertebra, can be identified relative to a CT-hased model, fluoroscopy images, or digitized landmarks of the anatomy,

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Carlos L. Pena -S

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."

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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).