The VERTE-STACK™ Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACK™ Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, Titanium DYNALOK™ CLASSIC Spinal System, Laurain DeWald Anterior Fixation System, Titanium TSRH® Spinal System, Titanium CD HORIZON® Spinal System, the Titanium GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK™ device is intended to be used with bone graft.

Device Description

The VERTE-STACK™ device, is a stackable PEEK spacer, which inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine. The construct is not intended to be employed as a stand-alone device. The VERTE-STACK™ device is fabricated and manufactured from POLYETHERETHERKETONE (PEEK OPTIMA LT) as described by ASTM F-1579. The Tantalum marker used for this product is made to the voluntary standard of ASTM F-560. The VERTE-SPAN™ components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The VERTE-STACK™ Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability

AI/ML Overview

This is a 510(k) summary for a medical device (VERTE-STACK™ Spinal System), not a study analyzing AI/algorithm performance. Therefore, most of the requested information regarding acceptance criteria, study design, and AI performance metrics is not applicable to this document.

The document describes a spinal implant and its substantial equivalence to previously cleared devices. It does not contain any information about an algorithm, AI, or a study to prove device performance in the context of diagnostic or treatment algorithms.

However, I can extract information related to the device itself:

1. Table of "Acceptance Criteria" and Reported Device Performance:

The document doesn't present "acceptance criteria" in the typical sense of a pre-defined performance metric for an AI or diagnostic algorithm. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance" described is in terms of the device's design, materials, and intended use matching those of already approved devices.

Acceptance Criterion (Implied via Substantial Equivalence)	Reported Device Performance (VERTE-STACK™)
Material Composition	Fabricated from PEEK OPTIMA LT (ASTM F-1579) and Tantalum marker (ASTM F-560)
Intended Use	Vertebral body replacement in thoracolumbar spine (T1-L5) due to tumor or trauma (fracture)
Use with Supplemental Fixation	Must be used with additional anterior and/or posterior spinal instrumentation
Compatibility with Specific Systems	To be used with listed Medtronic Sofamor Danek fixation systems or their successors, and bone graft
Design/Configuration	Stackable PEEK spacer, rigidly lockable into various configurations
Clinical Efficacy/Safety	Implied by substantial equivalence to predicate devices (VERTE-SPAN™ Spinal System, DePuy AcroMed Stackable Cage System, OEC/Rezaian Spinal Fixator, Osteotech Vertebral Body Replacement device, PYRAMESH®-C Implant System) which have established safety and efficacy.

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

Not Applicable. This document is about a physical medical device, not an AI or algorithm. There is no "test set" in the context of data for an algorithm. The evidence for substantial equivalence is based on comparisons of design, materials, and indications for use against predicate devices.

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

Not Applicable. See point 2.

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

Not Applicable. See point 2.

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. There is no AI or algorithm involved in this submission.

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

Not Applicable. There is no algorithm.

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

Not Applicable as a "ground truth" for an algorithm. The "truth" in this context is the regulatory acceptance of predicate devices based on their established material properties, design, and clinical performance, all of which would have been supported by previous submissions (e.g., mechanical testing, potentially animal or limited human clinical data for the original predicates, and extensive literature on spinal fusion principles).

8. The sample size for the training set:

Not Applicable. There is no algorithm training set.

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

Not Applicable. There is no algorithm training set.

In summary: This document is a regulatory submission for a physical medical implant (VERTE-STACK™ Spinal System) demonstrating substantial equivalence to pre-existing, legally marketed devices. It does not involve any AI, algorithms, or studies of their performance.

Summary

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KC02(791 p%/

CONFIDENTIAL

AUG 2 6 2002

VERTE-STACK™ Spinal System 510(k) Summary May 2002

Medtronic Sofamor Danek Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

Proprietary Trade Name: VERTE-STACK™ Spinal System II.

III. Product Description

The VERTE-STACK™ Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability

IV. Indications

The VERTE-STACK™ Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACK™ Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, Titanium DYNALOK™ CLASSIC Spinal System, Laurain DeWald Anterior Fixation System, Titanium TSRH® Spinal System, Titanium CD HORIZON® Spinal System, the Titanium GDLH® Spinal System or their successors. Additionally, the VERTE-STACK™ device is intended to be used with bone graft.

V. Substantial Equivalence

Documentation was provided which demonstrated the VERTE-STACK™ Spinal System to be substantially equivalent to the previously cleared VERTE-SPAN™ Spinal System (K010930), the DePuy AcroMed Stackable Cage System (K001340) the OEC/Rezaian Spinal Fixator (K841189), the Osteotech Vertebral Body Replacement device (K012254), and the PYRAMESH®-C Implant System (K011406) in terms of its size, indications for use and use with supplemental fixation.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its body and head. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, with the eagle positioned in the center.

AUG 2 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard W. Treharne, Ph.D. Senior Vice President, Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K021791

Trade/Device Name: VERTE-STACK™ Spinal System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: May 30, 2002 Received: May 31, 2002

Dear Dr. Treharne:

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.

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 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); 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.

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Page 2 - Richard W. Treharne, Ph.D.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Mark McMillan

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

Enclosure

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May 2002

510(k) Number (if known): K021791

510(k) Number (if known):

Device Name: VERTE-STACK™ Spinal System

Indications for Use:

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

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional 1-2-96)

Mark A. Millican

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.