The NuVasive CoRoent 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.

The CoRoent L and XL platforms are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The CoRoent S platforms are intended for use for anterior cervical interbody fusion in patients with cervical degenerative disc disease (DDD) at one level from levels C2-C3 to C7- T1. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment. The System is intended to be used with supplemental fixation and autogenous bone graft only to facilitate the fusion.

Partial Vertebral Body Replacement

The NuVasive CoRoent System may also be used as a partial 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 CoRoent System is an implantable device manufactured from PEEK and titanium alloy that is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

AI/ML Overview

This is a spinal implant system (NuVasive CoRoent System), not an AI/ML powered device, so most of the requested information (acceptance criteria, study details, ground truth, training/test sets, expert evaluation, MRMC studies) is not applicable.

However, I can provide the relevant information from the document as it pertains to a traditional medical device submission:

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

For this type of device (spinal implant), acceptance criteria are primarily based on demonstrating substantial equivalence to previously cleared predicate devices in terms of:

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance
Equivalence in Indications for Use	Claimed to be equivalent
Equivalence in Design	Claimed to be equivalent
Equivalence in Material	Claimed to be equivalent
Equivalence in Function	Claimed to be equivalent
Mechanical Testing Performance	Mechanical testing was presented (specific results not detailed in submission summary)

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

Not Applicable. This submission is for a spinal implant system and does not involve AI/ML algorithms or a "test set" in the context of algorithm performance. The evaluation is against predicate devices and mechanical testing.

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. There is no "ground truth" establishment in the context of an AI/ML algorithm for this device. The regulatory review process involves FDA experts evaluating the submission.

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

Not Applicable. See point 3.

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

Not Applicable. This device is a physical spinal implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

Not Applicable. This is a physical device, not an algorithm.

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

Not Applicable. There is no "ground truth" as it would apply to an AI/ML algorithm. The "truth" for this submission is established through mechanical testing demonstrating performance characteristics (e.g., strength, durability) and detailed comparison to existing, cleared predicate devices to support substantial equivalence.

8. The sample size for the training set

Not Applicable. This device does not involve a training set for an AI/ML model.

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

Not Applicable. See point 8.

Summary of Study:

The document states: "Data was provided which demonstrated the NuVasive CoRoent System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, material, and function." It also mentions "Mechanical testing was presented."

No clinical tests were applicable or conducted for this 510(k) submission, indicating that the clearance was based on non-clinical data and comparison to predicates.

Summary

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KOS 1611 age 1 of 2 510(k) Premarket Notification NuVasive CoRoent System

5. 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:

A. Submitted by

Laetitia Cousin Director of Regulatory and Clinical Affairs, and Quality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, California 92121 Telephone: (858) 909-1868 Fax: (858) 909-2068

B. Device Name

Trade or Proprietary Name:	NuVasive CoRoent System
Common or Usual Name:	Spinal Implants
Classification Name:	Orthosis, spinal intervertebral fusion
Device Class:	Class II
Classification:	§888.3080
Product Code:	ODP

C. Predicate Devices

The subject device is substantially equivalent to similar previously cleared devices.

D. Device Description

E. Intended Use

Intervertebral Body Fusion

The NuVasive CoRoent System is indicated for intervertebral body fusion of the spinc in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion.

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Partial Vertebral Body Replacement

F. Substantial Equivalence

Data was provided which demonstrated the NuVasive CoRoent System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, material, and function.

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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 2 2008

NuVasive, Incorporated % Ms. Laetitia Cousin Director of Regulatory Affairs and Quality Assurance 4545 Towne Centre Court San Diego, CA 92121

Re: K081611

Trade/Device Name: NuVasive CoRoent System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: September 26, 2008 Received: September 29, 2008

Dear Ms. Cousin:

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. Iisting 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

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) promarket notification. The FDA finding of substantial equivalence of your device to a legally marketed prodicate 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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Survcillance Systems at (240) 276-3464. 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,

Mark M. Wilkerson

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

Enclosure

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Indications for Use Mark A. Mellema

510(k) Number

510(k) Number (if known): _ KO 8 I 6 I

Device Name: NuVasive CoRoent System

Indications for Use:

Intervertebral Body Fusion

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

The NuVasive CoRoent 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.

Partial Vertebral Body Replacement

Prescription Use X (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) Page 1 of 1

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.