The NuVasive CoRoent System is a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

Device Description

The NuVasive CoRoent System is an implantable PEEK vertebral body replacement device indicated for use in the thoracic and lumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues.

The device is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

AI/ML Overview

The provided text is a 510(k) summary for the NuVasive CoRoent System, a vertebral body replacement device. It does not describe acceptance criteria or a study proving that the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and mechanical testing.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts and their qualifications for ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study results.
Standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document explicitly states: "H. Summary of Clinical Tests (Not Applicable)." This indicates that no clinical studies were performed for this 510(k) submission to demonstrate the device meets specific performance criteria against a ground truth from human data. The assessment was based on non-clinical (mechanical) testing and comparison to predicate devices.

Summary

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VII. 510(k) Summary

K043405 Page 1 of 2

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of n decorantee with the 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

A. Submitted by

Laetitia Cousin Director of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, CA 92121 Telephone: (858) 909-1868 Date Prepared: February 1, 2005.

B. Device Name

Trade or Proprietary Name:	NuVasive CoRoent System
Common or Usual Name:	Vertebral Body Replacement Device
Classification Name:	Vertebral Body Replacement Device

C. Predicate Devices

The subject device is substantially equivalent to similar previously cleared devices.

D. Device Description

The device is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

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F. Comparison to Predicate Devices

As was established in this submission, the subject device is substantially equivalent to the following predicate devices:

K033517	Spinal Concepts Cadence™	Spinal concepts, Inc.
K011037	Vertebral Spacer	Synthes
K032476	NuVasive Mesh	NuVasive, Inc.
K041939	Blackstone VBR System	Blackstone Medical, Inc.

Engineering drawings, labeling, and mechanical testing have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device.

G. Summary of Non-Clinical Tests

Mechanical testing was presented.

H. Summary of Clinical Tests

(Not Applicable).

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with three wing-like shapes.

FEB - 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laetitia Cousin Director of Regulatory Affairs and Quality Assurance NuVasive, Inc. 4545 Towne Centre Court San Diego, California 92121

Re: K043405

Trade/Device Name: NuVasive CoRoent System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: December 9, 2004 Received: December 10, 2004

Dear Ms. Cousin:

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 - Ms. Laetitia Cousin

This letter will allow you to begin marketing your device as described in your Section 510(k) I mb lotel will and in your a 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 rr you abon't 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark McMullen

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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V. Draft Labeling

A. Indications for Use

510(k) Number (if known): __ K0 4 3405

NuVasive CoRoent System Device Name:

Indications for Use:

Mark N. Milken

al. Resterative, and Neurological Devices

510(k) Number K043405

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

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)

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.