The NuVasive CoRoent XL-F System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle or facet screws) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The devices are to be used in patients who have had at least six months of non-operative treatment.

The CoRoent XL-F System is intended for use in interbody fusions in the lumbar spine from L2 to L5, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) with up to Grade I spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The CoRoent XL-F System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

Brigade System

The Brigade System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade Standalone System (lordotic angles of 8° and 12°) is a standalone system. The Brigade Hyperlordotic System (lordotic angels of 15° to 30°) must be used with supplemental internal spinal fixation systems (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Brigade System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectorny in the treatment of symptomatic degenerative disc disease (DDD) with up to Grade I spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Brigade System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis, and when used in these patients at multiple levels, the Brigade Standalone System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

Device Description

The subject NuVasive Interfixated Interbody System are interbodies manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 PEEK-Optima® LT-1, with radiographic markers manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The devices all contain integrated screws made of titanium alloy, and include a hollow core or graft aperture which allows for packing of autograft to help promote a solid fusion. The subject implants contain small spikes or teeth on each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion.

The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. In addition to the integrated screws, the CoRoent XL-F System and Brigade Hyperlordotic System devices are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

AI/ML Overview

This document describes a 510(k) submission for the NuVasive® Interfixated Interbody System. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, not primarily to prove performance against specific acceptance criteria through a study with a dedicated test set and ground truth.

Therefore, many of the requested elements (acceptance criteria, device performance table, sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance, training set details) are not explicitly present in this document because the core of a 510(k) for this type of device often focuses on demonstrating equivalence to existing, already-approved devices rather than de novo performance studies with new acceptance criteria.

However, I can extract the information that is present:

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

This document does not provide a table of acceptance criteria or reported device performance metrics in the way one would expect for a performance study. The 510(k) application focuses on demonstrating substantial equivalence to predicate devices, implying that the subject device's performance is assumed to be comparable to these already-cleared devices.

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

The document states: "A retrospective clinical analysis was performed to support the use of the subject device as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis."
Sample Size: Not specified.
Data Provenance: Retrospective clinical analysis. Country of origin is not specified.

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 specified, as the primary means of demonstrating equivalence did not involve a study requiring expert-established ground truth for a test set in the traditional sense. The retrospective clinical analysis mentioned does not detail the method of ground truth establishment or expert involvement.

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

Not specified.

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, an MRMC comparative effectiveness study was not done. This device is an interbody fusion system (implantable medical device), not an AI-driven diagnostic tool that would typically involve human readers.

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

No, a standalone performance study was not done, as this is an implantable medical device and does not involve an algorithm separate from human intervention for its primary function. The document explicitly states: "This device does not contain software or electrical equipment."

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

For the "retrospective clinical analysis" mentioned, the ground truth would inherently be based on clinical outcomes data related to fusion efficacy and patient condition in patients with multilevel degenerative scoliosis, as assessed via standard clinical and radiographic follow-up methods post-surgery. However, the specific methodology or explicit "ground truth" definition for this analysis is not detailed in this document.

8. The sample size for the training set

Not applicable as this is not an AI/algorithm-driven device requiring a training set.

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

Not applicable as this is not an AI/algorithm-driven device requiring a training set.

Summary of what is present:

The document is a 510(k) clearance letter and summary for an interbody fusion device.
The primary method of demonstrating suitability for market was substantial equivalence to existing predicate devices (NuVasive CoRoent XL-F System, CoRoent Single Tab System, CoRoent XLR Standalone System, Brigade Hyperlordotic System, and CoRoent Thoracolumbar System).
No new performance testing was conducted for the current submission because "No new device designs for the CoRoent XL-F System and no new worst case sizes for the Brigade System are being introduced."
A retrospective clinical analysis was performed to support the use of the device for multilevel degenerative scoliosis, but details regarding sample size, specific outcomes measured, or how "ground truth" was established within that analysis are not provided in this regulatory document.
The device is an implantable system made of PEEK-Optima and titanium alloy, with integrated screws. It does not contain software or electrical equipment.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three interconnected lines or shapes.

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

April 20, 2016

NuVasive, Incorporated Ms. Michelle Cheung Associate, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K160051

Trade/Device Name: NuVasive® Interfixated Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: March 23, 2016 Received: March 23, 2016

Dear Ms. Cheung:

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 Parts 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" (21CFR 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,

Lori A. Wiggins -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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Indications for Use

K160051

Page 1 of 1

510(k) Number (if known)

K160051

Device Name NuVasive® Interfixated Interbody System

Indications for Use (Describe)

The NuVasive® Interfixated Interbody System is indicated for the following:

CoRoent XL-F System

Brigade System

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape resembling a stylized leaf or eye, followed by the company name "NUVASIVE" in gray capital letters. Below the name, there is a tagline that says "Speed of Innovation" in a smaller font.

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: Michelle Cheung, Esq. Associate, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-3360

Date Prepared: January 8, 2016

B. Device Name

Trade or Proprietary Name:	NuVasive® Interfixated Interbody System
Common or Usual Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Body Fusion Device

Device Class:	Class II
Classification:	21 CFR § 888.3080
Product Code:	OVD

C. Predicate Devices

The subject NuVasive Interfixated Interbody System is substantially equivalent to primary predicate NuVasive CoRoent XL-F System (K140479), and additional predicates NuVasive CoRoent Single Tab System (K131723), CoRoent XLR Standalone System (K100043), Brigade Hyperlordotic System (K123045), and CoRoent Thoracolumbar System (K153419).

D. Device Description

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Image /page/4/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. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font, with the word "Speed" in purple and the rest of the phrase in gray. The logo is clean and modern, with a focus on innovation and technology.

E. Intended Use

The NuVasive® Interfixated Interbody System is indicated for the following:

CoRoent XL-F System:

Brigade System:

The Brigade System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade Standalone System (lordotic angles of 8° and 12°) is a standalone system. The Brigade Hyperlordotic System (lordotic angles of 15° to 30°) must be used with supplemental internal spinal fixation systems (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Brigade System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) with up to Grade I spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Brigade System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis, and when used in these patients at multiple levels, the Brigade Standalone System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

F. Technological Characteristics

As was established in this submission, the subject Interfixated Interbody System is substantially equivalent to predicate device systems already 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.

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Image /page/5/Picture/0 description: The image is a logo for Nuvasive. The logo features a stylized purple and gray leaf-like shape on the left, followed by the word "NUVASIVE" in gray, block letters. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller, italicized font.

G. Performance Data

No new device designs for the CoRoent XL-F System and no new worst case sizes for the Brigade System are being introduced to the subject Interfixated Interbody System. Therefore, no performance testing was performed for this 510(k) submission.

A retrospective clinical analysis was performed to support the use of the subject device as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

H. Conclusions

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

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.