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 L.5) 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 describes a 510(k) submission for the NuVasive® Mesh Vertebral Body Replacement Device. This device is an implantable surgical device, not an AI/ML powered medical device. Therefore, much of the requested information (such as acceptance criteria for AI algorithms, sample sizes for training/test sets, expert adjudication methods, MRMC studies, and ground truth establishment for AI) is not applicable or present in this document.

However, based on the information provided, here's what can be extracted and inferred regarding the device's acceptance and validation:

Acceptance Criteria and Device Performance

The core "acceptance criteria" for a 510(k) submission for a non-AI medical device like this is substantial equivalence to legally marketed predicate devices. The "performance" is demonstrated through comparative analysis and mechanical testing, rather than an AI algorithm's metrics.

Acceptance Criteria Category	Reported Device Performance (as demonstrated for Substantial Equivalence)
Design	Substantially equivalent, if not identical, to predicate devices.
Materials of Composition	Substantially equivalent, if not identical, to predicate devices.
Indications for Use	Substantially equivalent to predicate devices.
Mechanical Properties	Demonstrated through mechanical testing to be substantially equivalent to predicate devices.
Safety and Effectiveness	Implied through substantial equivalence to legally marketed predicate devices.

Study Information

Sample size used for the test set and the data provenance:
- Not Applicable. This is a hardware implant. The "test set" in this context would refer to the mechanical tests performed on multiple units of the device to ensure consistency and meet engineering specifications. The document states "Mechanical testing was presented," but does not detail the number of units tested or their provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth in the context of AI/ML is not relevant here. The "ground truth" for a mechanical device is its physical and material properties and its performance under load, validated through engineering standards and testing. Expert input would come from engineers, material scientists, and potentially surgeons reviewing the design and testing protocols. No specific number or qualifications are mentioned for this type of review in the provided text.
Adjudication method for the test set:
- Not Applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in human expert labeling for AI ground truth. For mechanical testing, the "adjudication" is based on comparing test results against predefined engineering specifications and predicate device data.
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 a physical implant, not an AI system. MRMC studies are used for evaluating diagnostic systems, typically AI-powered, where human readers interpret medical images.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a physical device, the "ground truth" is established through engineering specifications, material science principles, and preclinical bench testing (e.g., fatigue testing, compression strength, pull-out strength). The document mentions "Mechanical testing was presented." The ultimate "ground truth" for its safety and effectiveness for its intended use is demonstrated by its substantial equivalence to predicate devices that have a history of safe and effective use.
The sample size for the training set:
- Not Applicable. Training sets are for AI algorithms. For a mechanical device, manufacturing processes involve quality control and statistical process control, but there isn't a "training set" in the AI sense.
How the ground truth for the training set was established:
- Not Applicable. As above, this concept doesn't apply to this type of device.

Summary of the "Study" (Demonstration of Substantial Equivalence)

The "study" or validation presented is a 510(k) submission focusing on demonstrating substantial equivalence to previously cleared predicate devices.

Evidence presented: Engineering drawings, labeling, and mechanical testing.
Comparison points: Design, materials of composition, and indications for use.
Conclusion: The device was deemed "substantially equivalent, if not identical, to its predicate devices."
Clinical Tests: Explicitly stated as "Not Applicable" (H. Summary of Clinical Tests). This indicates that no human clinical trials were conducted or required for this 510(k) clearance, as substantial equivalence was demonstrated through non-clinical means.

In essence, the "study" is a comprehensive regulatory comparison and non-clinical engineering validation rather than a clinical or AI performance study.

Summary

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K023319

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VII. 510(k) Summary

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

MAR 0 4 2003

A. Submitted by

Laetitia Bernard Manager of Regulatory Affairs and Quality Assurance NuVasive®, Incorporated 10065 Old Grove Road San Diego, CA 92131 Telephone: (858) 527-1918 Date Prepared: October 3, 2002.

B. Device Name

Trade or Proprietary Name: Common or Usual Name: Classification Name:

NuVasive® Mesh Vertebral Body Replacement Device 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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E. Intended Use

KO23319 Puge 2 of 2

F. Comparison to Predicate Devices

As was established in this submission, the subject device is substantially equivalent to other devices 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.

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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling three human profiles or faces arranged in a row, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 4 2003

Ms. Laetitia Bernard Manager of Regulatory Affairs and Quality Assurance NuVasive. Inc. 10065 Old Grove Road, Suite A San Diego, CA 92131

Re: K023319

Trade/Device Name: NuVasive Mesh Regulation Number: 21 CFR 888.3060 Regulation Name: Vertebral body replacement device Regulatory Class: II Product Code: MQP Dated: January 3, 2003 Received: January 6, 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.

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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 yours,

Mark N Milkman

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

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A. Indications for Use

510(k) Number (if known): KO23319

Device Name: NuVasive® Mesh

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ OR Over-The-Counter Use _
(Per 21 CFR 801.109)

Division Sign-Off

K023319

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.