The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent SHL interbody device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

Device Description

The NuVasive CoRoent Small Interbody System is a hollow interbody cage manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026. The implant contains a hollow core or graft aperture which allows for packing of autograft to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device includes marker pins composed of titanium alloy conforming to ASTM F136 and ISO 5832-3 or ASTM F1472 or tantalum conforming to ASTM F560 or ISO 13782. The pins serve as radiopaque markers allowing the location and orientation of the device to be seen radiographically during and after the procedure for position confirmation. The implants are available in flat or contoured endplates, and come in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device will be packaged and initially provided non-sterile, and is designed to be sterilized by the user before each use.

AI/ML Overview

This document refers to a 510(k) premarket notification for the NuVasive® CoRoent® Small Interbody System, an intervertebral body fusion device. The purpose of this submission is to modify the Indications for Use to include two-level cervical applications. As such, the presented information focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the expanded indications.

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly state "acceptance criteria" in terms of numerical thresholds for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. The performance is assessed through a clinical literature review for the expanded two-level indication.

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness for Two-Level Cervical DDD (for the modified indication)	"Based on the published clinical literature review, it was determined that the CoRoent Small Interbody System used in the treatment of two-level cervical degenerative disc disease has a safety and effectiveness profile that is similar to the predicate device."
Technological Equivalence to Predicate Devices	"The subject device was shown to have equivalent 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."
Material Conformance (for the device itself)	"A hollow interbody cage manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026." "marker pins composed of titanium alloy conforming to ASTM F136 and ISO 5832-3 or ASTM F1472 or tantalum conforming to ASTM F560 or ISO 13782."

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

Test Set Sample Size: Not explicitly stated as a defined "test set" with a specific sample size. The performance is based on a clinical literature review. This means the "sample size" would depend on the number of patients and studies included within that review.
Data Provenance: The document does not specify the country of origin of the data within the clinical literature review, nor does it explicitly state whether the studies were retrospective or prospective. It only mentions "published clinical literature review."

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)

This is not applicable to this submission. The "ground truth" for the modified indication is established through existing published clinical literature, not a new expert review for this specific submission. The FDA reviews the submitted literature and its interpretation.

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

This is not applicable. There was no new "test set" created that would require an adjudication method. The clinical literature review inherently relies on the adjudication and peer-review processes of the original studies it incorporates.

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

This is not applicable. This device is an intervertebral body fusion system, not an AI software/medical imaging device. Therefore, no MRMC study or AI-related comparative effectiveness analysis was performed or described.

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

This is not applicable. This device is a physical implant, not an algorithm, so standalone performance is not relevant in this context.

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

The "ground truth" for the safety and effectiveness for the expanded indication is based on published clinical outcomes data and findings from the clinical literature review.

8. The sample size for the training set

This is not applicable. This is a 510(k) submission for a physical medical device, not a machine learning or AI algorithm, so there is no concept of a "training set" as it relates to AI. The device's design and materials are based on established engineering principles and prior validated devices.

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

This is not applicable for the same reasons as point 8.

Summary

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

June 11, 2015

Nuvasive, Incorporated Martin A. Yahiro, M.D. Director, Medical Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K150362

Trade/Device Name: NuVasive® CoRoent® Small Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: May 14, 2015 Received: May 15, 2015

Dear Dr. Yahiro:

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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Page 2 - Martin Yahiro, M.D.

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/Resourcesfor You/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 vours.

Mark N. Melkerson -S

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K150362

Device Name

NuVasive® CoRoent® Small Interbody System

Indications for Use (Describe)

The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System is interior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent SHL interbody device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

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)

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

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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K150362 Page 1 of 1

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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 tagline "Speed of Innovation" in a smaller font below the word "NUVASIVE". The logo is clean and modern, and the colors are muted and professional.

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:

A. Submitted by:

Martin Yahiro, M.D. Director, Medical Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-3360

Date Prepared: June 10, 2015

B. Device Name

Trade or Proprietary Name:	NuVasive® CoRoent® Small Interbody System
Common or Usual Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Body Fusion Device with Bone GraftCervical

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

C. Predicate Devices

The subject CoRoent Small Interbody System is substantially equivalent to multiple predicate devices. NuVasive CoRoent Small Interbody System (K140003) serves as the primary predicate device; while NuVasive CoRoent System (K081611), NuVasive CoRoent Small Interbody System (K140921), NuVasive CoRoent Small Contoured Interbody System (K142050), Valeo™ Spacer System and Valeo™ II Interbody Fusion Device System (K142264) are additional predicates.

D. Device Description

The implants are available in flat or contoured endplates, and come in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

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Image /page/4/Picture/0 description: The image shows the logo for Nuvasive. 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, italicized font.

The subject device will be packaged and initially provided non-sterile, and is designed to be sterilized by the user before each use.

E. Indications for Use

F. Technological Characteristics

The subject CoRoent Small Interbody 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 have equivalent 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.

G. Performance Data

The purpose of this 510(k) is to modify the Indications for Use for the subject CoRoent Small Interbody System. A clinical literature review was performed to support the use of the subject device at two levels. Based on the published clinical literature review, it was determined that the CoRoent Small Interbody System used in the treatment of two-level cervical degenerative disc disease has a safety and effectiveness profile that is similar to the predicate device. No other changes have been made to the interbodies since their clearance in the CoRoent Small Interbody System 510(k) K140003, CoRoent Small Interbody System 510(k) K140921, and CoRoent Small Contoured Interbody System 510(k) K142050. Therefore, no new nonclinical testing was performed for the purpose of this submission.

H. Conclusions

Based on the indications for use, technological characteristics, clinical literature analysis, and comparison to predicate devices, the subject CoRoent Small Interbody System has been shown to be substantially equivalent to legally marketed predicate devices 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.