The NuVasive® Lateral VBR System is a partial or total 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 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 Lateral VBR System is a vertebral body replacement device manufactured from carbon-fiber PEEK (polyetheretone) and titanium alloy conforming to industry recognized standards that is available in a variety sizes to suit the individual pathology and anatomical conditions of the patient. The Lateral VBR System vertebral body replacement device is designed to address thoracolumbar pathologies utilizing implant placement though a lateral approach. This implant inserter is specifically designed to place and expand the implant device. Allograft or autograft material may be used to facilitate fusion. The subject device components are manufactured from Carbon-Fiber Reinforced PEEK-Optima® LT1CA30 (CFRP) and titanium alloy conforming to ASTM F136 and ISO 5832-3.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (NuVasive® Lateral VBR System), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as would be found in a clinical trial or a more comprehensive validation study for a novel device.

Consequently, much of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in this document. The document explicitly states: "No non-clinical or clinical studies were conducted."

However, I can extract the available information regarding performance data and the conclusion drawn from it.

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

Based on the document, "acceptance criteria" are not explicitly defined in a quantitative table with specific thresholds. Instead, the performance evaluations were conducted to demonstrate substantial equivalence to predicate devices. The reported "performance" is a qualitative conclusion based on meeting these equivalence criteria.

Performance Aspect	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance	Demonstrate equivalence to predicate devices for mechanical properties, presenting no new worst-case.	Static and dynamic axial compression, compression shear, and torsion (per ASTM F2077): The results demonstrate that the subject Lateral VBR System presents no new worst-case for performance testing. Wear debris testing (per ASTM F1714 and ASTM F1877): The results demonstrate that the subject Lateral VBR System presents no new worst-case for performance testing. Expulsion testing: The results demonstrate that the subject Lateral VBR System presents no new worst-case for performance testing. Cadaver testing: The results demonstrate that the subject Lateral VBR System presents no new worst-case for performance testing.

Study that proves the device meets the acceptance criteria:

The document states: "Nonclinical testing was performed to demonstrate that the subject Lateral VBR System is substantially equivalent to other predicate devices." The listed tests were:

Static and dynamic axial compression, compression shear, and torsion per ASTM F2077
Wear debris testing per ASTM F1714 and ASTM F1877
Expulsion testing
Cadaver testing

The conclusion from these tests was: "The results demonstrate that the subject Lateral VBR System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not specified. The document refers to "nonclinical testing" and does not detail the number of units tested.
Data provenance: Not specified. These were likely laboratory tests rather than human subject 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)

Not applicable/Not specified. "Ground truth" in the context of device performance testing generally refers to objective measurements and adherence to standard specifications, not expert interpretation of data.

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

Not applicable/Not specified. Adjudication methods are typically used for subjective assessments (e.g., image interpretation) or clinical endpoints, which were not part of this "nonclinical testing" as described.

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

No. The document explicitly states: "No non-clinical or clinical studies were conducted." This device is a physical implant, not an AI or diagnostic software.

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

No. This question is not applicable. The device is a physical implant, not an algorithm.

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

"Ground truth" was based on objective measurements from engineering and simulated use testing (e.g., mechanical properties, wear debris, expulsion resistance) in accordance with recognized ASTM and ISO standards. The "truth" implies that the device met the specified performance characteristics without presenting a "new worst-case" compared to predicate devices.

8. The sample size for the training set

Not applicable/Not specified. This is a physical device, and the concept of "training set" is generally for machine learning algorithms or for extensive R&D iterations which aren't detailed here. The documentation focuses on verification testing against established standards.

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

Not applicable. There was no "training set" in the context of this device's validation as presented in the document.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 7, 2014

Nuvasive, Incorporated Mr. Jeremy Markovich Senior Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K140563

Trade/Device Name: NuVasive® Lateral VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: July 3. 2014 Received: July 7, 2014

Dear Mr. Markovich:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm_ Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Ronald�@Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K140563

Device Name NuVasive® Lateral VBR System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Anton E. Dmitriev, PhD

Division of Orthopedic Devices

This section applies only to requirements of the Paperwork Reduction Act of 1995,

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Image /page/3/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray, and the words "Speed of Innovation" in purple below. The logo is simple and modern, and the colors are eye-catching.

510(k) Summary

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

Submitted by: A.

Jeremy Markovich Senior Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800

Date Prepared: February 28, 2014

B. Device Name

Trade or Proprietary Name:	NuVasive® Lateral VBR System
Common or Usual Name:	Spinal Vertebral Body Replacement Device,
Classification Name:	Spinal Vertebral Body Replacement Device,Spinal Intervertebral Body Fixation Orthosis
Device Class:	Class II
Classification:	21 CFR § 888.3060

MOP

C. Predicate Devices

Product Code:

The subject Lateral VBR System is substantially equivalent to the following predicate devices: NuVasive Ti Mesh System (K032476), SpineWave StaXx XD System (K052670 and K090315), SpineWave StaXx XDL System (K102315), Osteotech, Inc. VBR™ (K012254), NuVasive CoRoent System (K071795), and Aesculap Hydrolift VBR System (K083186).

D. Device Description

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E. Intended Use

F. Technological Characteristics

As was established in this submission, the subject Lateral VBR System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.

Performance Data G.

Nonclinical testing was performed to demonstrate that the subject Lateral VBR System is substantially equivalent to other predicate devices. The following testing was performed:

Static and dynamic axial compression, compression shear, and torsion per ASTM ● F2077
Wear debris testing per ASTM F1714 and ASTM F1877
Expulsion testing
Cadaver testing

The results demonstrate that the subject Lateral VBR System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate. No non-clinical or clinical studies were conducted.

H. Conclusions

Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject Lateral VBR System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.

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.