The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures at one or two contiguous levels (L2-Sl) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis at the involved levels. The patient should be skeletally mature and have had six months of non-operative treatment.

The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is a stand-alone system intended to be used with bone screws, autogenous bone graft and requires no additional supplementary fixations. One device is used per intervertebral space.

Device Description

The Optimus Anterior Lumbar Interbody Fusion (ALIF) system is a zero profile stand-alone interbody that combines the benefits of an anterior fixation plate and fusion device. Optimus is a modular design that consists of a center fixation plate, lordotic end caps and three bone screws for anterior fixation and stability. The bone screws thread into the fixation plate and pass through the superior and inferior openings of the end caps to fixate the implant with the adjacent vertebral bodies.

OPTIMUS is available in a variety of heights (9-13mm posterior), angles (6 to 14 degrees) and two footprints to accommodate variations in patient anatomy. The fixation plates are manufactured from Titanium (ASTM F136), and the end caps are available in PEEK (ASTM F2026) and titanium (Ti-6Al-4V, ASTM F136), and are plasma sprayed with CPtitanium (ASTM F1580). The bone screws manufactured from Titanium (ASTM F136) are Ø5mm and are available in lengths from 24 to 32mm.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA regarding the "Optimus ALIF System," an intervertebral body fusion device. The purpose of this specific submission is for a modification to a trial distractor instrument, not the core device itself. As such, the document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance data for the main implant.

Therefore, the requested information regarding acceptance criteria and a study proving device performance (especially for AI/software-as-a-medical-device type evaluations) is not applicable to this document. This submission is for a physical medical device (spinal implant) and its associated instrument, and the "performance testing" mentioned refers to cleaning and sterilization validation, not clinical efficacy or diagnostic accuracy studies typically associated with AI.

Here's why the questions are not applicable and what information can be gleaned:

1. A table of acceptance criteria and the reported device performance: This document does not contain such a table. The device is a physical implant, and its performance is assessed through substantial equivalence to a predicate device and via mechanical testing (which is not detailed in this summary). The summary mentions "Cleaning and steam sterilizations were performed to verify method suitability," which are performance tests for those specific aspects, not for the clinical performance of the implant.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. There isn't a "test set" in the context of diagnostic performance.
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 not a diagnostic device requiring expert interpretation of results.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI/diagnostic assistance device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a spinal implant's mechanical performance would come from engineering and biomechanical testing standards, which are not detailed here. Clinical success would be measured through patient outcomes in post-market studies, but this document is a pre-market clearance based on equivalence.
8. The sample size for the training set: Not applicable. There is no training set for an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

Information that can be extracted from the document related to the device:

Device Name: Optimus ALIF System
Predicate Device: Optimus ALIF System (K132596) - This indicates that the current submission is for a modification to an already cleared device, relying heavily on the equivalence to the original.
Purpose of Submission: A special 510(k) for a modification to the Optimus Stand-Alone ALIF System, specifically for the trial distractor instrument. This means the core implant design, materials, and function for which it was originally cleared are unchanged ("There are no changes being proposed for the Subject Device with respect to intended use, design, material composition, and function.").
Performance Testing Mentioned: "Cleaning and steam sterilizations were performed to verify method suitability." This refers to validation of sterilization processes for the instrument, not clinical performance of the implant.
Conclusion: "Based on comparison to the predicate device, the Subject Device has been shown to be substantially equivalent."

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

February 18, 2016

Amendia, Incorporated % Kristen Allen Senior Regulatory Affairs Specialist 1755 West Oak Parkway Marietta, Georgia 30062

Re: K160291

Trade/Device Name: Optimus ALIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: February 1, 2016 Received: February 3, 2016

Dear Ms. Allen:

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

{1}------------------------------------------------

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" (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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K160291

Device Name Optimus ALIF System

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for AMENDIA. The logo is in blue and consists of the word "AMENDIA" in a sans-serif font. To the left of the word is a blue square with the letter "A" in white. Below the word "AMENDIA" is the tagline "creating balanced solutions" in a smaller, lighter blue font.

510(k) Summary Optimus

Submitter:	Amendia, Inc.1755 W. Oak ParkwayMarietta, GA 30062
Contact Person:	Kristen AllenSr. Regulatory Affairs Specialist910-612-4153 (P). 877-420-1213 (F)

Date Prepared: February 7, 2016

Trade Name: Optimus ALIF System

Device Product Code OVD, 888.3080, Class II, Intervertebral body fusion device and Classification:

kallen@amendia.com (e-mail)

Primary Predicate Device: Optimus ALIF System (K132596)

Purpose of Submission: This special 510(k) is intended to gain clearance for a modification to the Optimus Stand-Alone ALIF System, specifically for the trial distractor instrument.

Device Description:

Indications and Intended use:

The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures at one or two contiguous levels (L2-SI) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with deqeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis at

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Amendia. The logo is in blue and consists of the word "AMENDIA" in a sans-serif font. Below the word "AMENDIA" is the tagline "creating balanced solutions" in a smaller font. The logo is simple and modern.

the involved levels. The patient should be skeletally mature and have had six months of non-operative treatment.

Summary of Technological Characteristics:

There are no changes being proposed for the Subject Device with respect to intended use, design, material composition, and function. The only change being proposed for the currently marketed device is a change in sterilization status for the Trial Distractor instrument (Class I).

Summary of Performance Testing:

Cleaning and steam sterilizations were performed to verify method suitability.

Conclusion:

Based on comparison to the predicate device, the Subject Device has been shown to be substantially equivalent.

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.