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

The Robotic Reference Frame is an accessory to the MAZOR X Stealth Edition system and is intended to enable navigation during spinal fusion and interbody procedures that utilize the MAZOR X Stealth Edition system.

Device Description

The NavLock trackers are compatible with the MAZOR X Stealth™ Edition system. The NavLock Trackers 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 subject NavLock Trackers have posts to affix reflective spheres, which are visible to the MAZOR X Navigation camera as a means of tracking the position of the attached surgical instrument.

The Robotic Reference Frame is an accessory to the MAZOR X Stealth™ Edition system. The Robotic Reference Frame has posts to affix reflective spheres, which are visible to the MAZOR X Navigation camera for tracking location during navigated procedures.

AI/ML Overview

Unfortunately, the provided text does not contain the specific details required to answer all parts of your request. It's a 510(k) summary for a medical device (NavLock Trackers and Robotic Reference Frame) which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than a detailed study report with all the acceptance criteria, sample sizes, and ground truth establishment methods for a performance study of an AI/algorithm-based device.

Here's an breakdown of what can and cannot be extracted from the text:

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

Acceptance Criteria	Reported Device Performance
Necessary navigational accuracy requirements	"The subject devices satisfy the necessary navigational accuracy requirements." (Specific numerical values for accuracy are not provided).
Functionality after multiple reprocessing cycles (cleaning and sterilization) and repeated use, remaining functional throughout its intended useful life.	"Tested functionality after multiple reprocessing cycles (cleaning and sterilization) and repeated use. Provides confirmation that the product remains functional throughout its intended useful life." (Specific number of cycles or lifespan details are not provided).

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

Sample size for the test set: Not provided. The document states "Testing conducted" and refers to "the subject devices" satisfying requirements, but gives no indication of the number of devices, patients, or data points used in the Navigational Accuracy Analysis or Accelerated Life Functionality tests.
Data provenance: Not provided. The document does not mention the origin of any data, whether prospective or retrospective, or country of origin.

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):

Not applicable / Not provided. These tests appear to be primarily engineering performance tests (navigational accuracy, durability) for hardware components, not a study evaluating an AI/algorithm's diagnostic or predictive performance against human experts. Therefore, there's no mention of experts establishing a "ground truth" for a test set in this context.

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

Not applicable / Not provided. Similar to point 3, this type of adjudication is typically for clinical or diagnostic studies involving human interpretation or consensus, which is not described here.

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 does not describe an MRMC study. The devices (NavLock Trackers and Robotic Reference Frame) are accessories for a navigation system (MAZOR X Stealth™ Edition system) and are for hardware tracking, not AI-driven image analysis or decision support that would typically involve human readers.

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

Not explicitly applicable in the AI sense. The devices themselves are hardware (trackers) that enable optical navigation. While the system (MAZOR X Stealth™ Edition) might involve algorithms, this document is about the physical accessories. The performance tests described (navigational accuracy, functionality) are "standalone" in the sense that they test the device's intrinsic mechanical/optical performance.

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

For the "Navigational Accuracy Analysis," the ground truth would likely be established through precise metrology equipment or other highly accurate measurement systems, rather than expert consensus or pathology, as it's a measure of physical tracking accuracy. However, the specific method is not detailed.
For "Accelerated Life Functionality," the ground truth is simply continued functionality and integrity of the device under stress, measured against engineering specifications.

8. The sample size for the training set:

Not applicable / Not provided. Since this document describes hardware accessories for a navigation system and not an AI or algorithm-based device that undergoes machine learning training, there is no "training set."

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

Not applicable / Not provided. (See point 8).

In summary:

This 510(k) summary provides a high-level overview of performance testing for medical device accessories. It confirms that the devices met "necessary navigational accuracy requirements" and maintained "functionality throughout its intended useful life" after reprocessing. However, it lacks the granular detail (specific numerical acceptance criteria, exact performance metrics, sample sizes, detailed ground truth methods, and expert involvement) that would be present in a comprehensive study report, especially one for an AI or algorithm-driven device. The focus here is on demonstrating equivalence to an existing predicate device rather than presenting a detailed clinical or AI algorithm validation study.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Medtronic Navigation Jainam Shah Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

November 2, 2018

Re: K182104

Trade/Device Name: NavLock Trackers, Robotic Reference Frame Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: August 2, 2018 Received: August 3, 2018

Dear Jainam Shah:

This letter corrects our substantially equivalent letter of November 2, 2018

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

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Page

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows a digital signature. The name "Jesse Muir -S" is prominently displayed on the left side of the image. To the right of the name, the text "Digitally signed by Jesse Muir -S Date: 2018.11.02 15:53:43 -04'00'" is displayed.

For 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)

K182104

Device Name NavLock Trackers

Indications for Use (Describe)

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.

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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K182104

Device Name Robotic Reference Frame

Indications for Use (Describe)

The Robotic Reference Frame is an accessory to the MAZOR X Stealth™ Edition system and it is intended to enable navigation during spinal fusion and interbody procedures that utilize the MAZOR X Stealth™ Edition system.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K182104

510(k) Summary

July 31, 2018

I. Company: Medtronic Navigation 826 Coal Creek Circle Louisville, CO 80027 Telephone Number: (720) 890-3200
- Contact: Jainam Shah Regulatory Affairs Specialist Telephone Number: (720) 890-2595 Fax: (720) 890-3500 Email: jainam.shah(@medtronic.com
II. Proprietary Trade Name: NavLock™ Trackers; Robotic Reference Frame
III. Common Name: Orthopedic Stereotaxic Instrument
IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
V. Classification: Class II
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 MAZOR X Stealth™ Edition system. The NavLock Trackers should only be used with Medtronic instruments on the MAZOR X Stealth™ Edition system.

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The Robotic Reference Frame is an accessory to the MAZOR X Stealth™ Edition system intended to enable navigation during spinal fusion and interbody procedures that utilize the MAZOR X Stealth™ Edition system.

IX. Identification of Legally Marketed Devices (Predicate Devices):

NavLock Trackers (K171267, S.E. 07/03/2017). This predicate has not been subject to any recall. This predicate is the primary predicate for this submission.

The following devices have been added as reference devices in this submission:

SteathStation® S8 Spine Software v1.0.0 (K170011, S.E. 05/01/2017) ●
SteathStation® S8 System (K162309, S.E. 03/31/2017). ●

X. Comparison of the Technological Characteristics:

The subject devices under this submission consist of the NavLock trackers and the Robotic Reference Frame. Both the subject devices are stereotaxic instruments intended to enable navigation during stereotactic spinal procedures that utilize the MAZOR X Stealth™ Edition system. A comparison of the technological characteristics is provided below:

Feature	Subject Devices (NavLockTrackers and RoboticReference Frame)	NavLock Trackers, K171267, S.E.07/03/2017
ProductCode	OLO	OLO
OperatingPrinciple(TrackingMethod)	Optical (infra-red)	Optical (infra-red)
IntendedUse	The subject devices areintended to enable navigationduring stereotactic spinalprocedures that utilize theMAZOR X StealthTM Editionsystem.	The NavLock trackers are intended toenable navigation of Medtronicinstrumentation during stereotacticspinal procedures that utilize theMedtronic StealthStation surgicalnavigation system.
Indicationsfor Use	The NavLock Trackers areintended to enable navigationof Medtronic instrumentationused during spinal fusion andinterbody procedures with theMAZOR X StealthTM Editionsystem. The NavLockTMTrackers should only be usedwith Medtronic instrumentson the Medtronic MAZOR XStealthTM Edition system.	The NavLock Trackers are intended toenable navigation of Medtronicinstrumentation used during spinalfusion and interbody procedures withthe Medtronic StealthStation surgicalnavigation system. The NavLockTrackers should only be used withMedtronic instruments.

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Feature	Subject Devices (NavLockTrackers and RoboticReference Frame)	NavLock Trackers, K171267, S.E.07/03/2017
	The Robotic Reference Frameis an accessory to theMAZOR X StealthTM Editionsystem and it is intended toenable navigation duringspinal fusion and interbodyprocedures that utilize theMAZOR X StealthTM Editionsystem.
SterilizationMethod	Non-Sterile, Reusable, SteamSterilized	Non-Sterile, Reusable, SteamSterilized

The difference in the indications for use between the subject devices and the predicate device is that the subject devices are compatible with the MAZOR X Stealth™ Edition system. The test data included with this submission supports the compatibility of the subject devices with the MAZOR X Stealth™ Edition system.

XI. Discussion of the Performance Testing:

Testing conducted to demonstrate equivalency of the subject device to the predicate device is summarized as follows:

Test	Description
NavigationalAccuracy Analysis	Provides confirmation that the subject devices satisfy thenecessary navigational accuracy requirements.
Accelerated LifeFunctionality	Tested functionality after multiple reprocessing cycles(cleaning and sterilization) and repeated use. Providesconfirmation that the product remains functional throughoutits intended useful life.

XII. Conclusions

The subject devices 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).