The NuVasive® Mesh is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The NuVasive® Mesh 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 Mesh is an implantable titanium 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 tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

A plurality of rhombic pattern holes are built in the wall, transverse to the longitudinal axis. The hollow core allows for packing of bone grafting materials to help promote a solid fusion. A ring of small spikes or teeth on each end of the device serves to grip the endplates of the adjacent vertebrae to resist expulsion.

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 Mesh, a vertebral body replacement device. It details the device's description, intended use, and comparison to predicate devices, focusing on demonstrating substantial equivalence based on design, materials, and mechanical testing. The document explicitly states that clinical tests were not applicable and focuses solely on non-clinical mechanical tests to establish equivalence, meaning there is no data presented regarding diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or human reader studies.

Therefore, many of the requested categories related to diagnostic performance and human studies cannot be answered from the provided text.

Here's a breakdown of the information that can be extracted:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly list specific acceptance criteria as numerical thresholds for diagnostic performance metrics (e.g., sensitivity, specificity, precision). Instead, the acceptance criteria are implicitly stated through the demonstration of substantial equivalence to a predicate device based on mechanical testing and design control activities.

Acceptance Criteria Category	Specific Criteria (Implicitly based on substantial equivalence)	Reported Device Performance
Mechanical Performance	Device meets performance standards comparable to predicate device for vertebral body replacement.	Mechanical testing was presented, demonstrating that acceptance criteria were met and design output satisfied design input. (Specific results not detailed in summary).
Material Composition	Identical or substantially equivalent material to predicate device.	"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..."
Design Characteristics	Identical or substantially equivalent design to predicate device.	"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..."
Indications for Use	Aligned with predicate device.	"Indications for Use: The NuVasive® Mesh is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture..." (Matches predicate device's indications).
Safety and Effectiveness	No new safety or effectiveness issues raised compared to predicate device.	"Due to this equivalency, the device raises no new safety or effectiveness issues."

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

Not applicable. This device is a mechanical implant, and the assessment was based on non-clinical mechanical testing and a comparison to its predicate device, not on a test set of patient data for diagnostic performance.

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

Not applicable. Ground truth for diagnostic performance is not relevant for a mechanical device's substantial equivalence determination.

4. Adjudication method for the test set

Not applicable.

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 not an AI-based diagnostic device.

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

Not applicable. This is not an AI-based diagnostic device. The "standalone" performance here would refer to the mechanical performance of the implant itself during testing.

7. The type of ground truth used

For the non-clinical mechanical testing, the "ground truth" would be established by engineering standards and specifications for material properties, structural integrity, and functional performance (e.g., load-bearing capacity, resistance to expulsion). These are determined against pre-defined engineering requirements and industry standards for vertebral body replacement devices.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" in the context of mechanical device testing for substantial equivalence, as there is no machine learning or AI algorithm being developed.

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

Not applicable, as there is no training set for an AI algorithm.

Summary

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

VII. 510(k) Summary

032476 ge I of 2

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular §807.92, the following summary of information is provided:

Submitted by: A.

Laetitia Bernard Manager of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 10065 Old Grove Road San Diego, California 92131 Telephone: (858) 527-1918 Telefacsimile: (858) 271-7101

B. Device Name

Trade Name: NuVasive Mesh Common or Usual Name: Vertebral Body Replacement Device Vertebral Body Replacement Device Classification Name:

C. Predicate Devices

The subject NuVasive Mesh is substantially equivalent to the NuVasive Mesh currently manufactured and distributed commercially in the U.S. by NuVasive, Inc.

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.

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

E. Intended Use

32476

The NuVasive Mesh is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The NuVasive® Mesh 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.

F. Comparison to Predicate Devices

As was established in this submission, the subject device is substantially equivalent to the current NuVasive Mesh cleared by the agency for commercial distribution in the United States.

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.

Due to this equivalency, the device raises no new safety or effectiveness issues.

G. Summary of Design Control Activities

Design control activities employed to control the development of the modification to the NuVasive Mesh included:

a comprehensive Risk Analysis to identify potential risks and failures associated with ● operation of the device, any mitigations incorporated to reduce or eliminate those risks and failures, and an assessment of residual risk;
a comprehensive program of verification and validation activities demonstrating that . acceptance criteria were met, and that design output satisfied design input.

H. Summary of Clinical Tests

(Not applicable.)

H. Summary of Non-Clinical Tests

Mechanical testing was presented.

J. Conclusions

The subject device is substantially equivalent to the currently marketed predicate device, and its development has been adequately and appropriately conducted and validated under a comprehensive design control program complying with Title 21 CFR, §820.30.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of a human profile with three faces, representing the department's focus on health and human well-being. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2003

Ms. Laetitia Bernard Manager of Regulatory Affairs & Quality Assurance NuVasive, Incorporated 10065 Old Grove Road San Diego, California 92131

Re: K032476

Trade/Device Name: NuVasive Mesh Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: October 31, 2003 Received: November 3, 2003

Dear Ms. Bernard:

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 - Ms. Laetitia Bernard

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" (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/dsma/dsmamain.html

Sincerely vours.

Mark N Millerson

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}------------------------------------------------

NuVasive®, Inc.

Page 1 of

D. Indications for Use Statement

510(k) Number (if known): K032476

Device Name: NuVasive Mesh

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use -(Per 21 CFR 801.109) OR

Over-The-Counter Use

R. Mark N. Milliken

on Sig A storative Division of Ge and Neurologic

510(k) Number: K032976

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.