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.

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 LT1) along with either titanium or tantalum markers. Alternatively the entire 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 VERTE-STACK® constructs may not be used with stainless steel supplemental fixation devices.

AI/ML Overview

This 510(k) summary describes a modification to an already cleared device, the VERTE-STACK® Spinal System. The provided document therefore focuses on demonstrating substantial equivalence to previously cleared predicates rather than presenting de novo performance studies with acceptance criteria as would be required for a novel device.

The original submission for the VERTE-STACK® was based on mechanical testing to ensure the device's structural integrity and functionality for its intended use, rather than a clinical study measuring AI performance. The provided document does not contain information typically associated with AI/ML device evaluations.

Therefore, many of the requested fields cannot be filled.

Acceptance Criteria and Study for VERTE-STACK® Spinal System

Based on the provided 510(k) summary for the VERTE-STACK® Spinal System, the device described is a medical implant (a vertebral body replacement device) and not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as it relates to AI/ML performance (e.g., accuracy, sensitivity, specificity, effect size with human readers) is not applicable here.

Instead, for this type of medical device, the acceptance criteria would typically relate to:

Mechanical performance: demonstrating that the device can withstand the physiological loads and stresses it will encounter in the spine (e.g., compression, torsion, bending, fatigue life).
Biocompatibility: ensuring the materials used are safe for implantation in the human body.
Sterilization: verifying that the device can be effectively sterilized without compromising its integrity.
Design and manufacturing specifications: ensuring the device is manufactured consistently and according to its intended design.
Substantial equivalence: comparing the device features and indications for use to legally marketed predicate devices.

The "study" that proves the device meets the acceptance criteria would primarily involve non-clinical testing (e.g., mechanical bench testing) and comparative analysis to predicate devices.

Summary of Device Performance and Equivalence Claim:

The purpose of this specific 510(k) (K062133) is to include "slightly modified components" to the previously cleared VERTE-STACK® Spinal System. Therefore, the primary "study" proving its acceptance criteria is a demonstration of substantial equivalence to the previously cleared versions of the VERTE-STACK® Spinal System (K060719 and K041556).

Here's a breakdown of the requested information, adapted for a non-AI/ML medical device submission focused on substantial equivalence:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion (Implied for Spinal Implants)	Reported Device Performance / Evaluation Method
Substantial Equivalence to Predicate Devices	"Documentation was provided which demonstrated that the subject VERTE-STACK® Spinal System components are substantially equivalent to components previously cleared in VERTE-STACK® Spinal System 510(k) applications K060719 (SE 04/14/06) and K041556, (SE 07/01/04)."
Material Biocompatibility (e.g., PEEK OPTIMA LT1, Titanium, Tantalum)	The device is fabricated from well-established biocompatible materials (PEEK OPTIMA LT1 with titanium/tantalum markers or entire titanium alloy). Implicitly accepted due to prior clearance of these materials in spinal implants. No specific testing reported in this summary.
Mechanical Integrity & Performance (e.g., strength, fatigue)	Not explicitly detailed in this summary, but would have been part of the original predicate device clearances (K060719, K041556). The modifications are "slightly modified components," implying previous mechanical testing results are still applicable or updated as needed.
Safety and Effectiveness for Indications for Use (Thoracolumbar spine T1-L5)	Demonstrated through substantial equivalence to predicate devices with identical indications for use.

Sample size used for the test set and the data provenance:
- Not applicable. This submission relies on substantial equivalence to predicate devices, not a test set of data in the context of an AI/ML device. The "test" is the comparison to existing cleared devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment by experts for a test set is described. The FDA's review process itself involves experts (e.g., regulatory reviewers, engineers, clinicians) who evaluate the submission for substantial equivalence.
Adjudication method for the test set:
- Not applicable. No test set requiring adjudication in the AI/ML context.
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 not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm/AI device.
The type of ground truth used:
- Not applicable. For this type of device and submission, the "ground truth" for substantial equivalence is the regulatory acceptance and performance history of the predicate devices. The safety and effectiveness of the predicate devices are typically established through a combination of non-clinical testing, design specifications, and clinical experience (or sometimes clinical studies for PMAs or more complex devices).
The sample size for the training set:
- Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.

Summary

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K06 2133
Page 1 of 2

VERTE-STACK® Spinal System 510(k) Summary July 2006

I. Company:	Medtronic Spinal and Biologics Division 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
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SEP 26 2006

Contact: Lee Grant Supervisor, Regulatory Affairs

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

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

IV. Product Code: MQP

V. 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.

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The purpose of this submission is to include slightly modified components to t previously cleared VERTE-STACK® Spinal System.

VI. 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, 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.

VII. Substantial Equivalence

Documentation was provided which demonstrated that the subject VERTE-STACK® Spinal System components are substantially equivalent to components previously cleared in VERTE-STACK® Spinal System 510(k) applications K060719 (SE 04/14/06) and K041556, (SE 07/01/04).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a family of three people.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 26 2006

Medtronic Sofamor Danek % Mr. Lee Grant Supervisor Regulatory Affairs 1800 Pyramid Place Memphis, Tennessee 38132

Re!+ K062133 -----------------------------------------------------------------------------------------------------------------------------------------------------------------

Trade/Device Name: VERTE-STACK® Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: August 29, 2006 Received: August 30, 2006

Dear Mr. Grant:

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 - Mr. Lee Grant

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" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson 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):

K062133

Device Name: VERTE-STACK® Spinal System

Indications for Use:

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)

(Division Sign-C Division of General, Restor and Neurological Devices

510(k) Number /i.sc/ 133

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.