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, the DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the 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 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) along with a tantalum marker. Alternatively the device may be manufactured from titanium alloy.

The design of the VERTE-STACK™ device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.

The VERTE-STACK™ device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

The VERTE-STACK™ Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK™ constructs manufactured with PEEK may be used with stainless steel or titanium supplemental fixation devices. Titanium VERTF-STACK™ constructs may not be used with stainless steel supplemental fixation devices.

The purpose of this submission is to include a titanium version of previously cleared VERTE-STACKTM Spinal System components.

AI/ML Overview

The provided text describes a 510(k) submission for the VERTE-STACK™ Spinal System, which is a vertebral body replacement device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies with acceptance criteria in the same way a PMA (Pre-Market Approval) study would.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes for test/training sets, expert involvement, and ground truth establishment are not typically part of a 510(k) submission document like this. The primary "study" in a 510(k) is a comparison to a predicate device.

Here's an analysis based on the provided document:

1. Table of acceptance criteria and reported device performance

The document does not provide specific quantitative acceptance criteria or detailed performance results in the format of a clinical study for the VERTE-STACK™ Spinal System. For a 510(k) submission, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device in terms of indications for use, technological characteristics, and safety and effectiveness.

Acceptance Criteria (Implicit for 510(k))	Reported Device Performance (Summary from text)
Indications for Use Equivalence	Met: The Indications For Use for the VERTE-STACK™ Spinal System are stated as being for vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or trauma, to be used with supplemental fixation and bone graft. These were found substantially equivalent to the predicate devices.
Technological Characteristics Equivalence	Met: The submission is specifically to include a titanium version of the previously cleared VERTE-STACK™ components. The original PEEK version uses a tantalum marker. The core function and design principles are considered equivalent to the predicate.
Safety and Effectiveness Equivalence	Met: Demonstrated by showing substantial equivalence to previously cleared devices (VERTE-STACK™ K031780 and VERTE-SPAN™ K010930). This implies that the device is considered as safe and effective as the predicate.

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

Sample Size for Test Set: Not applicable in the context of a 510(k) for a spinal implant. There is no "test set" in the sense of a patient cohort or imaging dataset used to evaluate an algorithm. The evaluation is primarily based on comparison to predicate devices and engineering/material data (which are not detailed in this summary).
Data Provenance: Not applicable.

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

Not applicable. Ground truth establishment with experts is typical for diagnostic algorithms, not for spinal implants in a 510(k) submission.

4. Adjudication method for the test set

Not applicable. There was no test set requiring expert adjudication.

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 is a medical device (spinal implant), not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (spinal implant), not an algorithm.

7. The type of ground truth used

The "ground truth" for a 510(k) for a medical device like this is the established safety and effectiveness of its predicate devices, backed by clinical use and regulatory clearance. The basis of comparison focuses on material properties, design specifications, and indications for use.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning model.

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

Not applicable.

Summary

{0}------------------------------------------------

MAR 1 9 2004

VERTE-STACK™ Spinal System 510(k) Summary February 2004

K040422
10F2

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

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

Classification Name: Spinal Intervertebral Body Fixation Orthosis (21 CFR III. 888.3060)

III. Product Description

The design of the VERTE-STACK™ device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.

The purpose of this submission is to include a titanium version of previously cleared VERTE-STACKTM Spinal System components.

000089

{1}------------------------------------------------

Indications IV.

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 Danck ZPLATE II Anterior Fixation System, the DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, the GDLH® Spinal System and/or their successors. Additionally, the VERTE-STACK™ device is intended to be used with bone graft.

Substantial Equivalence V.

Documentation was provided which demonstrated the VERTE-STACK™ Spinal System to be substantially equivalent to the previously cleared VERTE-STACK™ Spinal System (K031780, SE 07/30/03) and to the VERTE-SPAN™ Spinal System (K010930, SE 10/24/01).

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

MAR 1 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek Memphis, Tennessee 38132

Re: K040422

Trade/Device Name: VERTE-STACK™ Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: February 17, 2004 Received: February 18, 2004

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.

{3}------------------------------------------------

Page 2 .. Richard 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), please contact the Office of Compliance at (301) 594-4659. 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,

sincerely yours,

Mark A. Williams

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

{4}------------------------------------------------

0404da

510(k) Number (if known):

Device Name:__________________________________________________________________________________________________________________________________________________________________

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) OR Over-The-Counter Use __
and/or (Optional 1-2-96)

Mark A. Millican
Review Sign-Off

Division of General, Restorative,
and Neurological Devices

Number K040122
mxm

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.