The NIKO™ Corpectomy Spacer 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 NIKO™ Corpectomy Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.

The NIKO™ Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Device Description

The NIKO™ Corpectomy Spacer device is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of the device will grip the endplates of the adjacent vertebrae to resist expulsion.

NIKO devices are made from radiolucent polymer, and titanium alloy or tantalum as specified in F2026, F136, F1295, and F560.

AI/ML Overview

The provided text is a 510(k) summary for the NIKO Corpectomy Spacer. It describes the device, its intended use, and states that performance data from mechanical testing in accordance with FDA guidance is presented. However, it does not include specific acceptance criteria, reported device performance metrics in a table, details of a study proving the device meets these criteria, or information about sample sizes for test/training sets, ground truth establishment, or multi-reader multi-case studies.

Therefore,Based on the provided text, I cannot complete the table of acceptance criteria and device performance, nor can I provide answers to most of the requested questions. The document focuses on regulatory approval based on "substantial equivalence" to a predicate device, rather than detailed performance study results against specific criteria.

Here's what can be extracted from the text:

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

This information is not available in the provided document. The document states "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." However, it does not explicitly list the acceptance criteria used in this testing or the specific performance results.

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 available in the provided document. The document refers to "mechanical testing," which typically involves material and device testing, not patient data.

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/available. The device is a physical implant, and the performance data described is mechanical testing, not a diagnostic or prognostic algorithm requiring expert-established ground truth from medical images or clinical data.

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

This information is not applicable/available for the same reasons as point 3.

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:

This information is not applicable/available. The device is a physical implant, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable/available. The device is a physical implant, not an algorithm.

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

This information is not applicable/available. For mechanical testing, the "ground truth" would be engineering specifications and standards, not clinical ground truth.

8. The sample size for the training set:

This information is not applicable/available. The device is a physical implant, not a machine learning model that requires a training set.

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

This information is not applicable/available for the same reasons as point 8.

Summary of what is available from the text:

Device Name: NIKO™ Corpectomy Spacer
Intended Use: Vertebral body replacement device for the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). Intended to be used with supplemental spinal fixation systems.
Performance Data: "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." (No specific details of the results or acceptance criteria are provided in this summary).
Basis of Substantial Equivalence: Similar to the predicate device, Sustain Radiolucent Spacer (K040284), with respect to indications for use, material, principles of operation, and performance.

Summary

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111. 510(k) Summary

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SUBMITTED BY:

Globus Medical Inc. 2560 General Armistead Ave Audubon, PA 19403 (610) 415-9000 Contact: Kelly J. Baker

2007 OCT 4

DEVICE NAME:

NIKO™ Corpectomy Spacer

CLASSIFICATION:

Per CFR 21 §888.3060: Implant, fixation, spinal intervertebral body fixation orthosis devices. Class II. The Product Code is MQP. The Panel Code is 87.

PREDICATE DEVICES:

Sustain Radiolucent Spacer K040284; SE date March 23, 2004

DEVICE DESCRIPTION:

NIKO devices are made from radiolucent polymer, and titanium alloy or tantalum as specified in F2026, F136, F1295, and F560.

INTENDED USE:

PERFORMANCE DATA:

Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented.

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BASIS OF SUBSTANTIAL EQUIVALENCE:

The NIKO™ Corpectomy Spacer implants are similar to the predicate vertebral body replacement device, Sustain Radiolucent Spacer (K040284), with respect to indications for use, material, principles of operation, and performance.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Globus Medical Inc. % Ms. Kelly Baker Valley Forge Business Center 2560 General Armistead Avenue Audubon, PA 19403

2007

Re: K072465

Trade/Device Name: NIKOTM Corpectomy Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: August 30, 2007 Received: September 4, 2007

Dear Ms. Baker:

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

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Page 2 – Ms. Kelly Baker

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.

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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Pvet

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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ll. Indications for Use Statement

510(k) Number:

NIKO™ Corpectomy Spacer Device Name:

Indications:

The NIKO™ Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Prescription Use × (Per 21 CFR §801.109)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clarbare RniemD

. Restorative, and Neurological Devices

510(k) Number K072463

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.