The CoRoent XLR-Standalone System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The CoRoent XLR-Standalone System is intended for use with autograft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CoRoent XLR-Standalone System.

When used as a partial Vertebral Body Replacement (VBR):

The CoRoent XLR-Standalone System is a standalone system indicated for use in the thoracolumbar spine (T1-L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The CoRoent XLR-Standalone System is also indicated for treating fractures of the thoracic and lumbar spine. The CoRoent XLR-Standalone System is intended to be used with autograft or allograft.

Device Description

The NuVasive CoRoent XLR-Standalone 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

The provided document is a 510(k) Summary for a medical device called the NuVasive CoRoent® XLR Standalone System. This type of submission focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than presenting a performance study with acceptance criteria in the same way a de novo or PMA submission might.

Therefore, the information typically found in acceptance criteria tables and detailed performance studies for AI/ML devices (like sensitivity, specificity, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies) is not present in this document.

Here's a breakdown of why and what information is available:

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

Not Applicable in this context. This document does not define specific clinical acceptance criteria (e.g., target true positive rate, false positive rate) that the device must meet, nor does it report performance against such criteria.

Instead, it focuses on nonclinical testing for substantial equivalence:

Acceptance Criteria (Implicit): The implicit acceptance criterion is that the device's mechanical performance (e.g., strength, durability, wear) must be "substantially equivalent" to or "meets or exceeds the performance of the predicate device" as determined by the specified ASTM standards and work items.

Reported Device Performance:

Test Performed	Reported Device Performance
Static and dynamic torsion per ASTM F2077	Meets or exceeds the performance of the predicate device.
Static and dynamic compression per ASTM F2077	Meets or exceeds the performance of the predicate device.
Wear Debris per ASTM F2077 & ASTM F1877	Meets or exceeds the performance of the predicate device.
Subsidence per ASTM F2267	Meets or exceeds the performance of the predicate device.
Expulsion per ASTM Work Item Z8423Z	Meets or exceeds the performance of the predicate device.

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 document describes nonclinical, mechanical testing of physical implants, not testing on patient data or a "test set" in the context of AI/ML or clinical efficacy studies. Therefore, there's no "data provenance" related to patient data or sample sizes for clinical evaluation.

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. This is a mechanical device, not an image analysis or diagnostic AI. "Ground truth" in this context refers to the defined parameters and methodologies of the ASTM standards themselves, which are established by expert consensus within their respective fields, but not in the same way as clinical "ground truth" for a diagnostic algorithm.

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

Not Applicable. No adjudication method is mentioned as this is not a diagnostic device or a study involving human interpretation of data. The "adjudication" is determined by whether the device's mechanical properties meet the specified ASTM standard thresholds.

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 is a physical intervertebral body fusion device, not an AI or imaging device that would involve human readers.

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

Not Applicable. This refers to a physical implant, not an algorithm. The "standalone system" in the device name refers to its ability to achieve fusion without requiring additional supplemental internal fixation, not to an algorithm operating independently.

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

Not Applicable / Indirectly "Expert Consensus". The "ground truth" for nonclinical mechanical testing is implicitly established by the ASTM (American Society for Testing and Materials) standards themselves. These standards are developed through a consensus process involving engineers, scientists, and industry experts to define repeatable and reliable testing methodologies and performance benchmarks for medical devices.

8. The sample size for the training set

Not Applicable. This document describes the 510(k) submission for a physical medical device. There is no "training set" in the context of machine learning or AI algorithms. The device itself is manufactured; it does not "learn" from data.

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

Not Applicable. As there is no training set, there is no ground truth established for it.

Summary

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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:

JUN 1 J 2010

Sheila Bruschi Senior Regulatory Affairs Associate Nu Vasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 320-4515 Fax: (858) 320-4615

Date Prepared: June 4, 2010

B. Device Name

	Trade or Proprietary Name:	NuVasive CoRoent® XLR Standalone System
	Common or Usual Name:	Intervertebral Body Fusion Device, Spinal PartialVertebral Body Replacement Device
Classification Name:	Intervertebral Body Fusion Device, Spinal PartialVertebral Body Replacement Device
Device Class:	Class II
Classification:	§888.3060, §888.3080
Product Code:	MQP, MAX

C. Predicate Devices

The subject CoRoent® XLR Standalone System is substantially equivalent to the following predicate devices currently distributed commercially in the U.S .:

. K073109 - SurgiCraft STALIFTM TT System
K081849 Blackstone Medical PILLARTM SA PEEK Spacer System ●
K072253 - Synthes SynFix™-LR
K081501 Biomet Spine Solitaire™ Anterior Spinal System ●
K083475 Spinal Elements Lucent® Magnum+ ●

D. Device Description

E. Intended Use

When used as an intervertebral body fusion device:

The CoRoent XLR-Standalone System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or

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two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The CoRoent XLR-Standalone System is intended for use with autograft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CoRoent XLR-Standalone System.

When used as a partial Vertebral Body Replacement (VBR):

F. Technological Characteristics

As was established in this submission, the subject CoRoent XLR-Standalone 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, function, and range of sizes.

Performance Data G.

Nonclinical testing was performed to demonstrate that the subject CoRoent XLR-Standalone System is substantially equivalent to other predicate devices. The following testing was performed:

Static and dynamic torsion per ASTM F2077
Static and dynamic compression per ASTM F2077 ●
Wear Debris per ASTM F2077 & ASTM F1877 ●
. Subsidence per ASTM F2267
Expulsion per ASTM Work Item Z8423Z .

The results of these studies showed that the subject CoRoent XLR-Standalone System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.

H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject subject CoRoent XLR-Standalone System has

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Image /page/2/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized graphic to the left of the word "NUVASIVE" in all caps. Below the company name is the text "Creative Spine Technology" in a smaller font size.

been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines, and the overall design is simple and clean. The logo is often used to represent the department on official documents and websites.

Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NuVasive, Inc. % Ms. Sheila Bruschi Senior Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121

SEP 12 2011

Re: K100043 Trade/Device Name: NuVasive CoRoent® XLR Standalone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MOP Dated: May 18, 2010 Received: May 19, 2010

Dear Ms. Bruschi:

This letter corrects our substantially equivalent letter of June 16, 2010.

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 (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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Mark A. Milkersen

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: NuVasive® CoRoent® XLR Standalone System

Indications For Use:

When used as an intervertebral body fusion device:

The CoRoene XLR-Standalone System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is delined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the invoived level(s). The CoRoent XLR-Standalone System is intended for use with autograft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CoRoent XLR-Standalone System.

When used as a partial Vertebral Body Replacement (VBR):

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.