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, 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.

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 corpoctomy. 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 VERTE-STACK™ constructs may not be used with stainless steel supplemental fixation devices.

AI/ML Overview

This 510(k) summary for the VERTE-STACK™ Spinal System (K040536) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

Instead, this document is a regulatory submission for a medical device that demonstrates substantial equivalence to a previously cleared device. Substantial equivalence is the primary pathway for medical device approval in the U.S. when a new device is similar enough to an existing legally marketed device (predicate device).

Here's why the requested information is absent and what this document does provide:

Acceptance Criteria and Reported Device Performance: This document does not include performance metrics (like sensitivity, specificity, accuracy) or acceptance criteria for such metrics because it's not a clinical trial report or a study evaluating a diagnostic or predictive algorithm. The "performance" being assessed here is the device's functional and safety characteristics compared to its predicate.
Sample Size for Test Set and Data Provenance: Not applicable. There is no "test set" in the sense of a dataset for evaluating an algorithm's performance. The "testing" involved would typically be mechanical, biocompatibility, and sterilization testing to ensure the device itself meets established standards and is equivalent to the predicate. Such details are usually summarized but not presented with raw data in the 510(k) summary itself.
Number of Experts for Ground Truth and Qualifications: Not applicable. Ground truth, in the context of diagnostic or predictive algorithms, refers to the true medical condition or outcome. This device is an implantable spinal system, not a diagnostic tool requiring expert interpretation of images or data to establish ground truth.
Adjudication Method: Not applicable for the same reasons as above.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is relevant for evaluating human reader performance with and without AI assistance, which is not the purpose of this device.
Standalone Performance Study: Not applicable. This type of study is for evaluating an algorithm's performance independent of human input. The VERTE-STACK™ is a physical medical implant.
Type of Ground Truth Used: Not applicable.
Sample Size for Training Set: Not applicable. There is no algorithm being trained.
How Ground Truth for Training Set was Established: Not applicable.

What the document does indicate regarding "equivalence" and "purpose":

Substantial Equivalence (Section V): The core of this submission is to demonstrate that the VERTE-STACK™ Spinal System is substantially equivalent to a previously cleared device, VERTE-STACK™ Spinal System K030601 (cleared on March 25, 2003). This means the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
Product Description (Section III): The device is a "stackable spacer" for vertebral body replacement, made from PEEK OPTIMA LT or titanium alloy, and used with supplemental fixation. The purpose of this specific submission (K040536) is "to include a modified version of previously cleared VERTE-STACK™ Spinal System BOOMERANG™ PEEK components." This implies that the modifications were minor enough not to require a completely new evaluation, but still necessitated demonstrating equivalence.
Indications for Use (Section IV and Enclosure): The device is 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), always with supplemental fixation and bone graft.
Regulatory Conclusion: The FDA's letter (K040536) confirms that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed under general controls.

In summary, this 510(k) pertains to a physical medical implant device and not a diagnostic or AI algorithm. Therefore, the requested information regarding acceptance criteria and performance studies in the context of AI or diagnostic accuracy is not present in this type of regulatory submission. The "study" here is the comparison to a predicate device, demonstrating equivalent safety and effectiveness through design, materials, and intended use.

Summary

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K040536

VERTE-STACKTM Spinal System 510(k) Summary February 2004

MAY - 5 2004

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)

Product Description III.

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 corpoctomy.

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 VERTE-STACK™ constructs may not be used with stainless steel supplemental fixation devices.

The purpose of this submission is to include a modified version of previously cleared VERTE-STACK™ Spinal System BOOMERANG™ PEEK components.

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Indications IV.

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 K030601 (SE 03/25/03).

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2004

Dr. Richard W. Treharne Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K040536

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: April 15, 2004 Received: April 16, 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 complics 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 Cl·R 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 - Dr. Richard W. Treharne

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 premaince noticated 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,

Mark A. Wilkerson

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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510(k) Number (if known):

VERTE-STACK™ Spinal System Device Name:__

Indications for Use:

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, 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.

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

K040536

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)

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Mark A. Wilkerson

al. Restorative. Division of Gener and Neurological Devices

510(k) Number K040536

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.