Ozark™ Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

Device Description

The Ozark Cervical Plate System consists of variable and fixed screws having self-tapping and self-starting tips, and one- through five-level plates. The implants are offered both sterile and non-sterile.

AI/ML Overview

This document describes the Ozark™ Cervical Plate System, a Class II medical device used for anterior screw fixation to the cervical spine. The Food and Drug Administration (FDA) has determined that this device is substantially equivalent to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Standard)	Reported Device Performance (Ozark™ Cervical Plate System)
ASTM F1717 (Static Compression)	Met acceptance criteria
ASTM F1717 (Dynamic Compression)	Met acceptance criteria
ASTM F1717 (Static Torsion)	Met acceptance criteria

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

The document does not explicitly state the specific sample sizes for the mechanical tests. It only mentions that "Mechanical testing of the Ozark Cervical Plate System constructs was performed according to ASTM F1717". The data provenance refers to laboratory testing of device constructs according to a recognized standard rather than clinical data from human subjects. Therefore, there is no information on country of origin or whether the data was retrospective or prospective in the context of patient data.

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

Not applicable. The "ground truth" for this device is based on standardized mechanical testing according to ASTM F1717, not on expert clinical interpretation of images or patient data. The results of these tests are objective measurements of the device's physical properties.

4. Adjudication Method for the Test Set

Not applicable. As mechanical tests, the results do not require adjudication by human experts in the same way clinical diagnostic interpretations would. The tests generate quantitative data that are compared against predefined limits within the ASTM F1717 standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and 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 surgical implant (cervical plate system), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for demonstrating the device's performance is established by validated mechanical testing standards, specifically ASTM F1717. This standard defines the methodologies and acceptable performance limits for spinal implant constructs under various mechanical loads (static and dynamic compression, static torsion).

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant and does not involve machine learning or AI models that require a "training set" of data.

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

Not applicable. As explained above, no training set is relevant for this type of device.

Summary

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

K2M Inc. % Karen E. Warden, PhD BackRoads Consulting, Inc. PO Box 566 12520 Heath Road Chesterland, Ohio 44026

August 23, 2017

Re: K172104

Trade/Device Name: Ozark™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: July 11, 2017 Received: July 12, 2017

Dear Dr. Warden:

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

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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 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 (DICE) 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 (DICE) 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.

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 on last page.

510(k) Number (if known)

K172104

Device Name Ozark™ Cervical Plate System

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)

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)

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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.

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Section 8 - 510(k) Summary

Date:	11 July 2017
Sponsor:	K2M Inc.600 Hope Pkwy. SELeesburg, Virginia 20175Phone: 703.777.3155
Sponsor Contact:	Nancy Giezen
510(k) Contact:	Karen E. Warden, PhDBackRoads ConsultingPO Box 566Chesterland, OH 44026Office: 440.729.8457
Trade Name:	Ozark™ Cervical Plate System
Common Name:	Anterior cervical plate system
Regulatory Class:	Class II
Classification Name,Regulation, ProductCode:	Appliance, fixation, spinal intervertebral body, 888.3060, KWQ
Device Description:	The Ozark Cervical Plate System consists of variable and fixed screwshaving self-tapping and self-starting tips, and one- through five-level plates.The implants are offered both sterile and non-sterile.
Intended Use:	Ozark™ Cervical Plate System is indicated for use in anterior screw fixationto the cervical spine (C2-T1) for the following indications: degenerative discdisease (DDD) (defined as neck pain of discogenic origin with degenerationof the disc confirmed by history and radiographic studies), spondylolisthesis,trauma (including fractures), spinal stenosis and tumors (primary andmetastatic), failed previous fusions (pseudarthrosis) and deformity (definedas scoliosis, kyphosis or lordosis).
Materials:	The Ozark Cervical Plate System implants are manufactured from titaniumalloy as described by ASTM F136 and ASTM F1472.
Primary Predicate:	Pyrenees Cervical Plate System (K2M - K152281)
Additional Predicates:	Additional: Zavation Cervical Plate System (Zavation LLC - K130030),SKYLINE® Anterior Cervical Plate System (DePuy Spine Inc. - K103491,VueLock® Anterior Cervical Plate System (Biomet Spine [nee EBI] -K023133), Cervical Spine Locking Plate (CSLP) (Synthes Spine - K030866)
Performance Data:	Mechanical testing of the Ozark Cervical Plate System constructs wasperformed according to ASTM F1717 and included static and dynamiccompression and static torsion.The mechanical test results demonstrate that the Ozark Cervical PlateSystem device performance is substantially equivalent to the predicatedevices.
TechnologicalCharacteristics:	The Ozark Cervical Plate System possesses the same technologicalcharacteristics as the predicate devices. These include:design features,●material,●anatomic location and,●dimensional attributes.●Therefore the fundamental scientific technology of the Ozark Cervical PlateSystem devices is the same as previously cleared devices.

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The Ozark Cervical Plate System possesses the same intended use and Conclusion: technological characteristics as the predicate devices. Therefore the Ozark Cervical Plate System is substantially equivalent for its intended use.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.