The GX Navigation Instruments are intended to be used during the preparation and placement of Life Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System, which 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The GX Navigation Instruments are compatible with the following Life Spine implant systems: ARx Spinal System, Avatar Extended Tab MIS System, Nautilus Thoracolumbar Spinal System, Centerline Thoracolumbar Spinal System and Centric-T System.

Device Description

The GX Navigation instruments are manufactured from Stainless Steel as specified in ASTM F899, non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® System. Refer to the appropriate navigation system Instructions for Use and/or Surgical Technique Guide for details regarding navigation system use.

AI/ML Overview

The provided FDA 510(k) summary for the GX Navigation Instrument System does not contain detailed information regarding acceptance criteria and a specific study proving the device meets those criteria in the context of AI/machine learning performance. The document focuses on establishing substantial equivalence to predicate devices, primarily through design, materials, and mechanical performance testing.

However, based on the information provided, we can extract details related to the performance testing that was submitted:

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

The document mentions "Testing according to Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems testing to ASTM F2554-18 was presented to demonstrate substantial equivalency."

While specific numerical acceptance criteria and reported values are not provided in this summary, the standard ASTM F2554-18 focuses on positional accuracy. For a stereotaxic instrument, the key performance metric would be the accuracy with which it guides the surgeon to the intended anatomical location.

Acceptance Criteria (Implied by standard)	Reported Device Performance
Positional Accuracy (as per ASTM F2554-18)	Demonstrated substantial equivalency to the Medtronic CD HORIZON® Spinal System (K170679) based on this testing. Specific quantitative results are not provided in this summary.
Functionality and compatibility with Medtronic® StealthStation® System using NavLock tracker	Design validation performed to ensure acceptability for intended use and functionality. Specific results not provided.
Dimensional comparison and tolerance analysis	Performed to ensure acceptability for intended use. Specific results not provided.

2. Sample size used for the test set and the data provenance:

The document does not specify a "test set" in the context of an AI/ML algorithm or a dataset for performance evaluation. The testing performed is described as "Testing according to Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems testing to ASTM F2554-18," which typically involves physical measurements on a phantom or test setup rather than a patient dataset. Therefore, information about data provenance (country of origin, retrospective/prospective) and sample size for a "test set" in the context of data-driven AI/ML is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided as the submission relates to a surgical navigation instrument system, not an AI/ML diagnostic or predictive device requiring ground truth from human experts on a dataset.

4. Adjudication method for the test set:

Not applicable, as the testing described does not involve human interpretation of a test set that would require an adjudication method.

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:

Not applicable. This device is a surgical navigation instrument, not an AI assistance tool for human readers/clinicians in diagnostic interpretation.

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

Not applicable. The device is an instrument system designed to be used with a navigation system (Medtronic StealthStation) and a surgeon. It is not a standalone algorithm.

7. The type of ground truth used:

For the positional accuracy testing (ASTM F2554-18), the ground truth would typically be established by precise metrology instruments or a known, highly accurate reference within the test setup, adhering to the specifications of the standard. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense for AI/ML.

8. The sample size for the training set:

Not applicable. This device does not appear to be an AI/ML device that requires a training set. The performance testing is based on physical and mechanical evaluations.

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 component.

Summary

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August 19, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Life Spine Inc. Angela Batker RA/QA Manager 13951 S Quality Drive Huntley, Illinois 60142

Re: K202836

Trade/Device Name: GX Navigation Instrument System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 11, 2021 Received: August 13, 2021

Dear Angela Batker:

We have reviewed your Section 510(k) premarket notification of intent to market the de vice 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 de vice, 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/cdrl/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/cdrl-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.

for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K202836

Device Name Gx Navigation Instrument System

Indications for Use (Describe)

The GX Navigation Instruments are compatible with the following Life Spine implant systems: ARX Spinal System, Avatar Extended Tab MIS System, Nautilus Thoracolumbar Spinal System, Centerline Thoracolumbar Spinal System and Centric-T 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)

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510(k) Summary GX Navigation Instrument System

Submitted By:	Life Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Angela BatkerLife Spine,Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	June 29th, 2021
Trade Name:	GX Navigation Instrument System
Common Name:	Stereotaxic Instruments
Classification:	CFR 882.4560, Class II, Stereotaxic instrument
Product Code:	OLO
Primary Predicate:	Medtronic CD Horizon (K170679)
Additional Predicates:	Life Spine Avatar/Nautilus & Centerline (K111953, K132760 &K151196)Life Spine ARx Spinal System (K200070 &K191575)

Device Description:

The GX Navigation instruments are for use with systems,

specifically:

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K202836 Page 2 of 3

ARx Spinal System

. Polyaxial Driver Non-Cannulated
. Polyaxial Driver Cannulated
. Monoaxial Driver Non-Cannulated
. Monoaxial Driver Cannulated
. Reduction Driver Non-Cannulated
. Reduction Driver Cannulated
Monoaxial Reduction Driver Non-Cannulated
. Monoaxial Reduction Driver Cannulated
. Non-Cannulated Taps

Cannulated Taps* Nautilus Thoracolumbar Spinal System

Polyaxial Driver Non-Cannulated ●
Polyaxial Driver Cannulated .
. Centric-T Modular Tap Driver
Reduction Driver Non-Cannulated .
Reduction Driver Cannulated ●
Non-Cannulated Taps •
. Cannulated Taps

Avatar Extended Tab MIS System

MIS Polyaxial Driver ●
Non-Cannulated Taps .
Cannulated Taps ●

Centerline Thoracolumbar Spinal System

Polyaxial Driver Non-Cannulated .
Polyaxial Driver Cannulated .
Reduction Driver Non-Cannulated ●
. Reduction Driver Cannulated
Non-Cannulated Taps .
. Cannulated Taps

Centric-T

Centric-T Modular Tap Driver ●
. Non-Cannulated Taps
. Cannulated Taps

Indications for Use:

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instruments are designed for use with the Medtronic StealthStation System, which 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The GX Navigation Instruments are compatible with the following Life Spine implant systems: ARx Spinal System, Avatar Extended Tab MIS System, Nautilus Thoracolumbar Spinal System,Centerline Thoracolumbar Spinal System and Centric-T System.

Technological Characteristics:

The GX Navigation System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.

Material:

This submission seeks clearance of just the GX Navigation Instrument System which are made from Stainless Steel according to F899. This this is the same material used in the predicate devices.

Performance Data:

Testing according to Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems testing to ASTM F2554-18 was presented to demonstrate substantial equivalency to the Medtronic CD HORIZON® Spinal System (K170679). Additionally, design validation, including dimensional comparison and tolerance analysis, was performed to ensure the GX Navigation Instrument System is acceptable for its intended use, to ensure functionality and compatibility with the Medtronic® StealthStation® System using the NavLock tracker, and to demonstrate substantial equivalence to the predicate instrument systems.

Substantial Equivalence:

GX Navigation Instrument System was shown to be substantially equivalent to the predicate devices Medtronic CD HORIZON® Spinal System (K170679), LifeSpine Nautilus/Avatar (K111953/K132760/K151196 & Life Spine ARX (K200070/K191575) in indications for use, design, function, materials used and mechanical performance.

Conclusion:

The information presented demonstrates the substantial equivalency of The GX Navigation Instrument System.

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).