The NuVasive Adjustable VBR System 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 Adjustable VBR 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 Adjustable VBR System includes different sized adjustable height core and endplates to suit the individual pathology and anatomical conditions of the patient. The cores can extend in height to properly match the anatomy and the endplates come in three major types: symmetric, asymmetric, and round.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria.

Here's a breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not provide explicit quantitative acceptance criteria or a study demonstrating the device's "performance" in the way one might expect for an AI/diagnostic device. Instead, the "acceptance criteria" are implied by the regulatory requirements for showing substantial equivalence to an existing predicate device.

The essential claim for acceptance is that:

The device has indications for use identical to its predicate.
The device employs the same principles of operation as its predicate.

Table of "Acceptance Criteria" (Implied) and Reported "Performance"

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device "Performance" (as per 510(k) Summary)
Identical Indications for Use (NuVasive Adjustable VBR System vs. NuVasive Mesh System)	The subject device has indications for use identical to those of its predicate.
Same Principles of Operation (NuVasive Adjustable VBR System vs. NuVasive Mesh System)	The subject device employs the same principles of operation.
Mechanical Performance (Appropriate for a vertebral body replacement system, typically verified via non-clinical tests)	Mechanical testing was presented (Summary of Non-Clinical Tests G). Specific results are not detailed in this summary.
Safety and Effectiveness (Demonstrated through substantial equivalence, without raising new questions of safety/effectiveness)	Found substantially equivalent by FDA, implying no new safety or effectiveness concerns were raised.

Study Details (as inferable from the document):

It's crucial to note that this 510(k) summary is for a physical medical device (Vertebral Body Replacement System), not an AI/diagnostic algorithm. Therefore, many of the typical questions for AI studies regarding training/test sets, ground truth, and reader studies are not applicable.

Sample size used for the test set and the data provenance:
- N/A. This is a physical device, and the "test set" would refer to mechanical testing samples, not a data set. The document states "Mechanical testing was presented" but does not detail the sample sizes or specific tests conducted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth in the context of diagnostic/AI performance is not relevant for this physical device. Mechanical properties would be assessed by engineering standards and experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Not relevant for mechanical testing of a physical implant.
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:
- No, N/A. This is a physical medical implant, not a diagnostic or AI-powered system that human readers would interact with.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. Not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. For this device, "ground truth" relates to mechanical properties meeting specifications, material compatibility, and structural integrity. This is typically established through engineering standards, material testing, and biomechanical studies, not clinical pathology or outcomes data in the sense of a diagnostic.
The sample size for the training set:
- N/A. Not an AI algorithm.
How the ground truth for the training set was established:
- N/A. Not an AI algorithm.

Summary of what was done according to the document:

Non-Clinical Tests: "Mechanical testing was presented." This is the primary "study" mentioned, aimed at demonstrating the physical device's performance characteristics (e.g., strength, durability, fatigue resistance) according to established standards for spinal implants. Details of these tests (sample size, specific methodologies, results) are not included in this summary.
Clinical Tests: "Not Applicable." This indicates that no human clinical trials were required for the 510(k) clearance, as substantial equivalence could be demonstrated based on non-clinical data and comparison to the predicate device.

Summary

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APR 2 7 2009

K090176
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Image /page/0/Picture/16 description: The image contains the logo for NUVASIVE, a medical device company. The logo features the company's name in a bold, sans-serif font. Below the name is the tagline "Curative Spine Technology" in a smaller, italicized font. The logo is simple and modern, reflecting the company's focus on innovation in spine surgery.

Special 510(k) Premarket Notification Adjustable VBR System

VII. 510(k) Summary

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:

A. Submitted by:

Ms. Han Fan Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-3338 Fax: (858) 909-3438

Device Name B.

Trade or Proprietary Name: Common or Usual Name: Classification Name: Device Class: Classification: Product Code:

NuVasive Adjustable Vertebral Body Replacement System Spinal Intervertebral Body Fixation Orthosis Spinal Intervertebral Body Fixation Orthosis Class II 888.3060 MQP

C. Predicate Devices

The subject Adjustable Vertebral Body Replacement System is substantially equivalent to the NuVasive Mesh System currently distributed commercially in the U.S. by NuVasive.

D. Device Description

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E. Intended Use

Comparison to Predicate Devices F.

The subject device has indications for use identical to those of its predicate, and employs the same principles of operation.

Summary of Non-Clinical Tests G. 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 seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and care. 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

Nuvasive, Inc. % Han Fan 7475 Lusk Boulevard San Diego, California 92121

APR 2 7 2009

Re: K090176

Trade/Device Name: Adjustable Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP Dated: April 9, 2009 Received: April 10, 2009

Dear Ms. Fan:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Han Fan

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

t-a
Mark N. Melkerson

Mark N. Me. Director Division of General, Restorative, And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K090176
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Indications for Use

K090176 510(k) Number (if known):

Device Name:____Adjustable VBR System

Indications For Use:

Perh

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number L050176

Prescription Use (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)

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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.