The NuVasive® MLX™ - Medial Lateral Expandable Lumbar Interbody 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 MLX – Medial Lateral Expandable Lumbar Interbody System is 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. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the MLX - Medial Lateral Expandable Lumbar Interbody System. The MLX -Medial Lateral Expandable Lumbar Interbody System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

Device Description

The NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System is manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6Al-4V conforming to ASTM 1472, and Nitinol SE508 conforming to ASTM F2063. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. This 510(k) covers design changes to MLX - Medial Lateral Expandable Lumbar Interbody System (K140770).

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the NuVasive® MLX™-Medial Lateral Expandable Lumbar Interbody System. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance (demonstrated through nonclinical testing):	The subject device exhibited performance comparable to the predicate devices in the following tests:
Dynamic axial compression per ASTM F2077	Met: Testing was performed per ASTM F2077. (Specific numerical results are not provided in this summary, but the conclusion states "the subject NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System has been shown to be substantially equivalent to legally marketed predicate devices.")
Dynamic torsion per ASTM F2077	Met: Testing was performed per ASTM F2077. (Specific numerical results are not provided.)
Static push-out per ASTM Draft Standard F-04.25.02.02 (work item Z8423Z)	Met: Testing was performed per ASTM Draft Standard F-04.25.02.02. (Specific numerical results are not provided.)
Structural Integrity (demonstrated through Finite Element Analysis and engineering rationale):	The modified design does not create a new worst-case scenario for performance.
Equivalent or improved structural integrity compared to predicate devices with design modifications	Met: Finite Element Analysis (FEA) and engineering rationale were provided as evidence that the modified design does not create a new worst case for performance testing. (Specific FEA results or comparisons are not provided in this summary.)
Material Composition (demonstrated through material standards compliance):	Materials used conform to established standards.
Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3	Met: Manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3.
Ti-6Al-4V conforming to ASTM F1472	Met: Manufactured from Ti-6Al-4V conforming to ASTM F1472.
Nitinol SE508 conforming to ASTM F2063	Met: Manufactured from Nitinol SE508 conforming to ASTM F2063.

2. Sample Size Used for the Test Set and Data Provenance

The document only describes nonclinical testing and Finite Element Analysis (FEA) for the device. Clinical data (human subject testing) for a "test set" in the context of device performance in patients (e.g., efficacy, safety) is not mentioned in this 510(k) summary. The testing described is pre-market, bench-top lab testing for mechanical properties and computational analysis.

Therefore, the concepts of "sample size for the test set" and "data provenance (country of origin, retrospective/prospective)" as they relate to human patient data are not applicable to the data presented in this particular 510(k) summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications

This information is not applicable as the data presented is from nonclinical (bench and computational) testing, not clinical studies requiring expert ground truth for patient outcomes. The "ground truth" here would be the established ASTM standards and engineering principles for mechanical testing and FEA. Product engineers and test lab personnel with relevant expertise would interpret these results.

4. Adjudication Method for the Test Set

This is not applicable as the document describes nonclinical mechanical and computational testing, not clinical studies that typically involve adjudication of patient outcomes or diagnostic interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

This is not applicable. This 510(k) pertains to a physical medical implant (intervertebral body fusion device), not an AI/software device that would typically undergo MRMC studies for diagnostic accuracy or physician assistance.

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

This is not applicable. The device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

For the nonclinical performance data, the "ground truth" is based on:

Established ASTM standards (e.g., F2077, F2063, F136, F1472) for material properties and mechanical testing.
Engineering principles and Finite Element Analysis (FEA) models for assessing structural integrity and predicting performance under various loads.

8. The Sample Size for the Training Set

This is not applicable. There is no mention of a "training set" in the context of machine learning or AI. The testing described focuses on evaluating the physical properties and performance of the manufactured device and its design changes.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the reasons stated in 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

July 11, 2016

NuVasive®, Incorporated Ms. Cynthia Adams Regulatory Affairs Specialist 7475 Lusk Boulevard San Diego, California 92121

Re: K153105

Trade/Device Name: MLX™-Medial Lateral Expandable Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 21, 2016 Received: June 22, 2016

Dear Ms. Adams:

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,

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.

K153105

Page 1 of 1

510(k) Number (if known)

K153105

Device Name

NuVasive® MLX™ - Medial Lateral Expandable Lumbar Interbody 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)

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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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:

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

Date Prepared: June 21, 2016

B. Device Name

Trade or Proprietary Name:	NuVasive® MLX™ – Medial Lateral Expandable Lumbar
	Interbody System
Common or Usual Name:	Intervertebral Body Fusion Device
Classification Name:	Spinal Intervertebral Body Fixation orthosis

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

C. Predicate Devices

The subject MLX – Medial Lateral Expandable Lumbar Interbody System is substantially equivalent to the primary predicate device, MLX - Medial Lateral Expandable Lumbar Interbody System (K140770), and additional predicate devices, NuVasive® Expandable Lumbar Interbody System (K130820), MLX – Medial Lateral Expandable Lumbar Interbody System (K151374), and NuVasive® CoRoent® Titanium System (K120918).

Device Description D.

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E. Intended Use

The NuVasive MLX™ - Medial Lateral Expandable Lumbar Interbody 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 NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System is 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. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System. The NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

F. Technological Characteristics

As was established in this submission, the subject NuVasive MLX - Medial Lateral Expandable Lumbar 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 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.

Performance Data G.

Nonclinical testing was performed to demonstrate that the subject NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System is substantially equivalent to the predicate device. The following testing was performed:

Dynamic axial compression per ASTM F2077 ●
Dynamic torsion per ASTM F2077
Static push-out per ASTM Draft Standard F-04.25.02.02 (work item Z8423Z)

Additionally, Finite Element Analysis (FEA) and engineering rationale were provided as the evidence that modified design of the MLX System device does not create new worst case for performance testing. The subject device was found to be substantially equivalent to the predicates.

H. Conclusions

Based on the indications for use, technological characteristics, performance data, and comparison to predicate devices, the subject NuVasive MLX - Medial Lateral Expandable Lumbar Interbody System has been shown to be substantially equivalent to legally marketed predicate devices.

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.