This system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels 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 device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Device Description

The Lumbar Interbody Fusion System consists of instruments and VESTAKEEP PEEK (per ASTM F2026) implants which will be offered in four (4) configurations of various sizes to accommodate individual patient anatomy. The configurations are designed pursuant to a specific surgical approach, and consist of the following: 1) Anterior Lumbar Approach (ALIF); 2) Posterior Lumbar Approach (PLIF); 3) Lateral Lumbar Approach (LLIF) and 4) Transforaminal Posterior Lumbar Approach (TPLIF). The implants are single use and the system is provided non-sterile.

AI/ML Overview

This document is a 510(k) Premarket Notification for a Lumbar Interbody Fusion System. It describes the device and its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

However, the provided text does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device submission. This document is for a traditional medical device (an implant) and the performance data described are related to mechanical testing, not a clinical study to evaluate diagnostic accuracy or human reader performance.

Therefore, many of your requested points are not applicable to the information provided in this document. I will fill in what I can and note where the information is not present.

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

Acceptance Criteria	Reported Device Performance
Mechanical Performance (as per ASTM F2077-14)
Static Axial Compression	Passed (indicates substantial equivalence)
Dynamic Axial Compression	Passed (indicates substantial equivalence)
Static Compression Shear	Passed (indicates substantial equivalence)
Dynamic Compression Shear	Passed (indicates substantial equivalence)
Static Torsion	Passed (indicates substantial equivalence)
Dynamic Torsion	Passed (indicates substantial equivalence)
Subsidence (as per ASTM F2267-04)	Passed (indicates substantial equivalence)
Expulsion	Passed (using a widely accepted and validated methodology, indicates substantial equivalence)

Note: The document states that "The above listed pre-clinical testing on the Subject device indicate that the Lumbar Interbody Fusion System is substantially equivalent to its predicate device(s)." This means the performance met the thresholds demonstrated by the predicate devices or relevant standards. Specific numerical acceptance values and actual measured performance data are not provided in this summary.

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

Sample Size for Test Set: Not applicable. This document describes mechanical bench testing of an implant, not a clinical study with a "test set" of patient data. The "sample size" would refer to the number of devices tested, which is not specified but would be dictated by the ASTM standards.
Data Provenance: Not applicable. The data comes from bench testing in a laboratory setting, not clinical data from patients.

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 device is an implant, and its performance is evaluated based on engineering and mechanical standards, not expert interpretation of diagnostic images or clinical outcomes in the context of an AI/ML device.

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

Not applicable. No expert adjudication method is mentioned as this is not an AI/ML device or a diagnostic study.

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. This is not an AI/ML medical device. No MRMC study was conducted.

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

No. This is not an AI/ML medical device.

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

Not applicable in the sense of clinical ground truth for an AI/ML device. The "ground truth" for this device's performance is defined by established engineering and mechanical testing standards (ASTM F2077-14 for mechanical properties, ASTM F2267-04 for subsidence, and a "widely accepted and validated methodology" for expulsion).

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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

November 16, 2016

Evolution Spine, LLC % John Siegel Chief Operating Officer LeoNine, LLC 819 S. 5th Street. Suite B Temple, Texas 76504

Re: K160663

Trade/Device Name: Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 18, 2016 Received: October 19, 2016

Dear Mr. Siegel:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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" (21 CFR 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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Indications for Use

510(k) Number (if known) K160663

Device Name

Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)

Indications for Use (Describe)

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

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

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Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) Premarket Notification 510(k) Summary

DATE PREPARED	November 10, 2016
MANUFACTURER	Evolution Spine, LLC4225 Office ParkwayDallas, TX 75204
CONTACT PERSON	Ashton KouzbariPresident214-682-8536mak@strategicancillaryservices.com
PREPARED BY	John SiegelCOOLeoNine, LLC819 South 5th Street, Suite BTemple, TX 76504610-457-5324john@leoninellc.com
PANEL CODE	Orthopaedics/87
CLASSIFICATION NAME	21 CFR 888.3080 - Intervertebral Fusion Device with BoneGraft, Lumbar
CLASS	Class II
COMMON NAME	Intervertebral Body Fusion Device, Lumbar (MAX)
TRADE NAME	Lumbar Interbody Fusion System (ALIF, PLIF, LLIF,TPLIF)
PREDICATE DEVICES	Primary: Python, manufactured by Eminent Spine(K090064)Reference: Cottonmouth, manufactured by Eminent Spine(K090064); K7 Lumbar Spacers, manufactured by K7, LLC(K133126); Opal Spacer, manufactured by Synthes(K072791)

DEVICE DESCRIPTION

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Lumbar Approach (LLIF) and 4) Transforaminal Posterior Lumbar Approach (TPLIF). The implants are single use and the system is provided non-sterile.

INDICATIONS and INTENDED USE

Intervertebral Body Fusion Device:

This system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of 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 device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Documentation was provided to demonstrate that the Subject Lumbar Interbody Fusion is substantially equivalent to the predicate device: Python Interbody Fusion Device (K090064). The Subject device is substantially equivalent to the predicate devices in intended use, indications for use, materials, technological characteristics, and labelling.

PERFORMANCE DATA

Static and dynamic axial compression, static and dynamic compression shear and static and dynamic torsion following ASTM F2077-14. Subsidence was tested following ASTM F2267-04. Expulsion was tested using a widely accepted and validated methodology. The above listed pre-clinical testing on the Subject device indicate that the Lumbar Interbody Fusion System is substantially equivalent to it predicate device(s).

CONCLUSION

The Lumbar Interbody Fusion System and its predicate(s) have the same intended use, to provide mechanical stability in the lumbar disc space to facilitate biologic fusion. The indications for use of the Subject device are identical to those of the predicate device. Minor differences between the Subject and predicate devices do not raise any new questions of safety or efficacy. Bench testing demonstrated that the differences do not adversely impact device mechanical performance. Based on the intended use, indications for use, technological characteristics, materials, and comparison to the predicate devices, the Subject Lumbar Interbody Fusion 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.