The NavLock™ Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with the Medtronic StealthStation system. The NavLock™ Trackers should only be used with Medtronic instruments.

Device Description

The NavLock Trackers are compatible with the StealthStation Systems and are used in conjunction with various navigated spine instrumentation for optical navigation. To enable navigation compatibility, the proximal ends of the instruments are designed to fit into the NavLock Trackers for optical navigation. The NavLock Trackers have posts to affix reflective spheres, which are visible to the StealthStation camera as a means of tracking the position of the attached surgical instrument.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Medtronic NavLock Trackers:

The provided text (K171267) is a 510(k) summary for the Medtronic NavLock Trackers. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific new acceptance criteria through novel performance studies.

Therefore, much of the requested information about direct acceptance criteria and a new study proving it is not present in the document, as the submission relies on the prior clearance of the predicate device.

Acceptance Criteria and Study Information for Medtronic NavLock Trackers (K171267)

1. Table of Acceptance Criteria and Reported Device Performance:

The document states, "There have been no significant design changes to the NavLock Trackers since K124004. As such performance testing is not needed to demonstrate substantial equivalence in the current submission." This indicates that the device's performance is asserted to be equivalent to the predicate (Medtronic Navigated Taps and Screwdrivers - K124004) and therefore implicitly meets the predicate's acceptance criteria.

The table below summarizes the types of performance testing conducted previously (to support K124004 and compatible instrumentation), but specific numerical acceptance criteria and reported performance values for those tests are not provided in this 510(k) summary.

Acceptance Criteria Category	Reported Device Performance (as implied by substantial equivalence to K124004)
Navigation Accuracy	Verified 2D and 3D navigational accuracy to meet requirements (specific values not provided in this document).
Anatomical Simulated Use	Validated that the product appropriately satisfies user needs through simulated surgical technique.
Navigation Simulated Use	Demonstrated that navigation-specific procedural steps can be executed for spinal procedures.
CAD Model Evaluation	Confirmed instrument CAD models accurately reflect physical instrument in software.
Implant/Instrument Mating Conditions	Verified design requirements for assembly, fit, and function with implant systems (for instruments that navigate implant placement).
Software/Instrument Integration	Confirmed required interface needs with spine application software (installation, system configuration, tool verification, functionality).

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

Sample Size for Test Set: Not specified in this document. The document states that no new performance testing was conducted for this submission because there were no significant design changes. The listed tests were conducted to support the original K124004 and compatible instrumentation.
Data Provenance: Not specified for the historical tests.

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

Not specified. This information would typically be detailed in the original studies for the predicate device (K124004) or compatible instrumentation, not in this substantial equivalence submission where new testing was deemed unnecessary.

4. Adjudication Method for the Test Set:

Not specified.

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, an MRMC comparative effectiveness study was not done. The device (NavLock Trackers) is a physical surgical instrument accessory for navigation, not an AI or imaging diagnostic device that would involve human readers interpreting cases.

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

Not applicable. The NavLock Trackers are physical components for a surgical navigation system and do not involve a standalone algorithm in the manner typically described for AI/software devices. The "algorithm" is part of the overall StealthStation surgical navigation system, and the trackers provide input for that system.

7. The Type of Ground Truth Used:

For the performance tests listed (e.g., Navigation Accuracy, Anatomical Simulated Use), the ground truth would likely have been established through:
- Metrology/Calibration Standards: For navigation accuracy.
- Expert Observation/Assessment: For simulated use tests, where surgical experts or trained personnel would evaluate task completion and performance against established protocols.
- Design Specifications: For CAD model evaluation and mating conditions.
- The specific method of establishing ground truth is not detailed in this 510(k) summary.

8. The Sample Size for the Training Set:

Not applicable / Not specified. As this is a physical device accessory for a navigation system, traditional "training sets" as understood in machine learning/AI models are not relevant. Any "training" would refer to internal validation data for the navigation system's software, which is not detailed here.

9. How the Ground Truth for the Training Set was Established:

Not applicable / Not specified for the reasons mentioned in point 8.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Medtronic Navigation Nicole Zimmerman Associate Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

July 3, 2017

Re: K171267

Trade/Device Name: NavLock Trackers Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 28, 2017 Received: Mav 1. 2017

Dear Nicole Zimmerman:

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-

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.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,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K171267

Device Name NavLock Trackers

Indications for Use (Describe)

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)

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K171267

510(k) Summary

April 28, 2017

I. Company: Medtronic Navigation 826 Coal Creek Circle Louisville, CO 80027 Telephone Number: (720) 890-3200
- Contact: Nicole Zimmerman Associate Regulatory Affairs Specialist Telephone Number: (720) 890-2342 Fax: (720) 890-3500 Email: nicole.r.zimmerman@medtronic.com
II. Proprietary Trade Name: NavLock Trackers
III. Common Name: Orthopedic Stereotaxic Instrument
IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
Classification: Class II V.
VI. Product Code: OLO

VII. Product Description:

VIII. Indications for Use:

The NavLock Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with the Medtronic StealthStation surgical navigation system. The NavLock Trackers should only be used with Medtronic instruments.

IX. Identification of Legally Marketed Devices (Predicate Devices):
Medtronic Navigated Taps and Screwdrivers (K124004)

X. Comparison of the Technological Characteristics:

There have been no changes to the technological characteristics of the NavLock Trackers since the clearance of the Medtronic Navigated Taps and Screwdrivers in K124004.

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Various navigated spine instruments that are compatible with the NavLock Trackers have been released since the original clearance but the NavLock Tracker technology has not changed.

XI. Discussion of the Performance Testing:

There have been no significant design changes to the NavLock Trackers since K124004. As such performance testing is not needed to demonstrate substantial equivalence in the current submission. Testing conducted to support the release of NavLock Trackers compatible instrumentation is summarized as follows:

Test	Description
Navigation Accuracy	Verifies 2D and 3D navigational accuracy of the subject instruments with respect to navigational accuracy requirements
Anatomical Simulated Use	Validates that the product appropriately satisfies the user needs by performing simulated use testing per the instructions outlined in the surgical technique.
Navigation Simulated Use	Demonstrates that the navigation-specific procedural steps can be executed to navigate a spinal procedure.
CAD Model Evaluation	Confirms the instrument CAD models are accurately reflected in the application software compared to the physical instrument.
Implant/Instrument Mating Conditions	For instruments that navigate placement of an implant, verifies design requirements associated with assembly, fit, and function of the navigated instruments with the implant system
Software/Instrument Integration Functional Testing	Confirms that the spine tools package has met the required interface needs of the spine application software with predetermined test items such as installation, system configuration, tool verification and functionality in the software application

XII. Conclusions

The NavLock Trackers have shown through 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).