When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the KOBRA™GPS Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the KOBRA™GPS Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

Device Description

The Medtronic Vertelink KOBRA™ GPS Fixation System consists of a variety of cannulated rods and cannulated multi-axial screws used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The KOBRA™ GPS Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The KOBRA™ GPS implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

AI/ML Overview

This document describes a 510(k) premarket notification for the Medtronic Vertelink KOBRA™ GPS Fixation System, a spinal intervertebral fixation device. It asserts substantial equivalence to previously cleared devices rather than presenting a study for acceptance criteria of device performance as one might expect for a novel AI/software medical device.

Therefore, the requested information cannot be fully provided because the provided text does not describe traditional clinical acceptance criteria or a study that proves the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to already approved predicate devices, which is the basis for 510(k) clearance.

Here's an explanation based on the provided text, highlighting what can and cannot be extracted:

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

The document does not specify quantitative acceptance criteria or a performance study comparing the device against such criteria. The "performance" assessment is based entirely on demonstrating substantial equivalence to predicate devices through documentation, including "test reports." However, the nature of these test reports and their specific criteria, device performance, and results are not detailed in the provided summary.

Acceptance Criteria (Not explicitly stated, inferred from 510(k) process for mechanical devices)	Reported Device Performance (Inferred from Substantial Equivalence Claim)
Mechanical and structural integrity comparable to predicate devices.	"Documentation, including test reports, was provided which demonstrated the Vertelink KOBRA™ GPS Fixation System to be substantially equivalent to the Vertelink KOBRA™ Fixation System components previously cleared in K032102 and to the CD HORIZON® Spinal System (K000453)."
Biocompatibility comparable to predicate devices.	(Not explicitly stated, but implied by substantial equivalence)
Functional equivalence for intended use (spinal fixation).	(Not explicitly stated, but implied by substantial equivalence)

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

This information is not provided in the document. The "test reports" mentioned are not described in detail. For mechanical devices like spinal fixation systems, "test sets" typically refer to samples of the device undergoing mechanical or material testing, not human patient data in the way an AI/software device would.

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)

This information is not applicable and not provided. "Ground truth" in the context of expert consensus is relevant for diagnostic or AI-driven devices. For a mechanical implant, the "ground truth" would be established by engineering specifications, material science, and biomechanical principles, not clinical expert consensus on diagnostic images.

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

Not applicable and not provided. Adjudication methods are typically used for clinical endpoints or diagnostic assessments, not for demonstrating substantial equivalence of a mechanical device.

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 and not provided. MRMC studies are relevant for evaluating the impact of AI on human readers (e.g., radiologists, pathologists). This device is a mechanical implant, not an AI or diagnostic software.

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

Not applicable and not provided. This device is a mechanical implant, not an algorithm or software.

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

As noted in point 3, the concept of "ground truth" as typically applied to diagnostic or AI devices is not directly applicable here. For a mechanical device, "ground truth" regarding its safety and effectiveness would be established through:

Engineering specifications and material properties: Conformance to established standards for materials, dimensions, and manufacturing.
Biomechanics and mechanical testing: Data from cadaveric studies, in-vitro fatigue testing, pull-out strength, and other mechanical tests to demonstrate performance under simulated physiological loads.
Clinical experience with predicate devices: The safety and effectiveness of the existing predicate devices (Vertelink KOBRA™ Fixation System and CD HORIZON® Spinal System) serve as the precedent for the new device based on substantial equivalence.

8. The sample size for the training set

Not applicable and not provided. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable and not provided.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence for a physical medical device (spinal fixation system) to previously cleared predicate devices. It does not contain information about clinical performance studies, reader studies, AI algorithms, or specific acceptance criteria in the way one would describe for an AI/software medical device. The "documentation, including test reports" mentioned is the basis for the substantial equivalence claim, but the details of these tests are not included here.

Summary

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NOV 2 4 2004

K042859

Medtronic Vertelink KOBRA™ GPS Fixation System Summary of Safety and Effectiveness October 2004

I. Company: Medtronic Vertelink, Inc 30 Hughes, Suite 206 Irvine, CA, 92618 (949) 455-1128

Contact: Samuel M. Shaolian Vice President, Product Development

II. Proposed Proprietary Trade Name: Vertelink KOBRA™ Fixation System
III. Classification Name: Spinal Intervertebral Fixation Orthosis and/or Pedicle Screw Spinal System (per 21 CFR Section 888.3060 and/or 888.3070) Class: Class II Product Code: MNH, MNI, KWO

IV. Product Description

V. Indications

VI. Substantial Equivalence

Documentation, including test reports, was provided which demonstrated the Vertelink KOBRA™ GPS Fixation System to be substantially equivalent to the Vertelink KOBRA™ Fixation System components previously cleared in K032102 and to the CD HORIZON® Spinal System (K000453).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 2004

Mr. Samuel M. Shaolian Vice President, Product Development Medtronic Vertelink, Inc. 30 Hughes, Suite 206 Irvine, California 92618

Re: K042859

Ro42039
Trade/Device Name: Vertelink KOBRATM GPS Fixation System Regulation Number: 21 CFR 888.3060, 888.3070 Regulation Name: Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWQ, MNI, MNH Dated: October 14, 2004 Received: October 15, 2004

Dear Mr. Shaolian:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can he 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); good manufacturing practice requirements as sct 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.

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Page 2 - Mr. Samuel M. Shaolian

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

fo Mark A. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known):_K042859

Device Name:_______________________________________________________________________________________________________

Indications For Use:

× Prescription Use ___ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millers
(Division Sign Off)

ral. Restorative. and Neurological Devices

Page 1 of __ 1 September 2004

510(k) Number K042854

Regulation Number and Section

N/A