The Axis Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion from levels C2 through T1 of the cervical spine. The system is indicated for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients. The indications include spinal stenosis, degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,), tumors, deformity (defined by kyphosis, lordosis, or scoliosis), and/or pseudoarthrosis (defined as failed previous fusion).

Device Description

Axis Anterior Cervical Plate System is a plate and screw system composed of medical grade titanium Ti-Alloy (Ti-6Al-4V ELI) components. The titanium plates are available in a variety of lengths, addressing multiple levels of fixation. The plates contain an integrated locking mechanism which interfaces with fixed and variable angled screws, of various diameters and lengths, to accommodate anatomical variation when securing the plate-screw construct to the anterior cervical vertebral bodies. The system is intended to provide mechanical support to the implanted level(s) until fusion is achieved. To accommodate normal cervical spine lordosis, and at the same time eliminate the need for additional plate contouring, Axis Anterior Cervical Plates come with a prelordosed curve. Various instruments are available to facilitate the implantation of the device.

AI/ML Overview

This document is a 510(k) summary for the Axis Anterior Cervical Plate System. It describes the device, its indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. The information provided is not about an AI/ML powered device, but a physical medical implant. Therefore, the requested information about acceptance criteria for an AI device, sample sizes for test/training sets, expert involvement, and ground truth establishment, which are typical for AI/ML validation studies, are not applicable here.

However, I can extract the information relevant to the performance assessment of this physical device as presented in the document itself.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this physical medical device are related to its mechanical performance, demonstrating equivalence to a predicate device based on specific ASTM standards.

Acceptance Criteria (based on ASTM Standards)	Reported Device Performance
Equivalence to predicate device per ASTM F1717-15 (Static Compressive Bending, Static Torsion, Fatigue Compression Testing)	The subject plate performed equivalently to the predicate device (Medtronic Atlantis Vision Anterior Cervical Plate System) in static compressive bending, static torsion, and fatigue compression testing as per ASTM F1717-15.
Sufficient screw performance per ASTM F543-13e1	The subject screws performed sufficiently to pass the evaluation criteria set forth in the protocol that was derived from the applicable ASTM standard (ASTM F543-13e1). (No specific quantitative values are provided in this summary, but it states the criteria were met.)
Geometric comparison to mechanical predicate	An engineering comparison (Appendix A, not provided in this excerpt) was performed, showing a geometric comparison between the subject AXIS device and a mechanical predicate (Exactech Ambassador). The conclusion implies this comparison supported substantial equivalence.

Study Proving Device Meets Acceptance Criteria:

A performance assessment was conducted through mechanical testing.

Study Type: Mechanical performance testing.
Standards Used: ASTM F1717-15 and ASTM F543-13e1.
Objective: To demonstrate that the Axis Anterior Cervical Plate System is equivalent to a predicate device with respect to the testing recommended in these ASTM standards.

The following sections are not applicable as this is not an AI/ML device:

2. Sample sized used for the test set and the data provenance: Not applicable. This refers to physical testing of the device components, not data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering and material science specifications and testing.
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.
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): The ground truth here is the established mechanical performance standards as outlined in ASTM F1717-15 and ASTM F543-13e1, and the performance of the predicate devices.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

April 5, 2018

Axis Orthopaedics % Mr. Steve Brown OA/RA Manager CoorsTek Medical 560 W. Golf Course Rd Providence, Utah 84332

Re: K173867

Trade/Device Name: Axis Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 22, 2018 Received: March 23, 2018

Dear Mr. Brown:

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 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);

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

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

for 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) K173867

Device Name

Axis Anterior Cervical Plate System

Indications for Use (Describe)

The Axis Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion from levels C2 through T1 of the system is indicated for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients. The indications include spinal stenosis, degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,), tumors, deformity (defined by kyphosis, lordosis, or scoliosis), and/or pseudoarthrosis (defined as failed previous fusion).

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)

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}------------------------------------------------

510(k) SUMMARY

Device Trade Name:	Axis Anterior Cervical Plate System
Date:	December 8, 2017
Sponsor:	Axis Orthopaedics
Contact Person:	Steve Brown
Manufacturer:	Axis Orthopaedics
Common Name:	Axis Anterior Cervical Plate System
Device Classification:	Class II
Classification Name:	Spinal intervertebral body fixation orthosis
Regulation:	888.3060

Device Regulation Panel: Orthopedic

Device Product Code: KWQ

Purpose:

The purpose of this Traditional 510(k) submission is to gain clearance for the Axis Anterior Cervical Plate System.

Device Description:

Indications for Use:

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

Legally Marketed Predicate Devices:

Primary: Medtronic Atlantis Vision Anterior Cervical Plate System (K021461) Secondary: Exactech Ambassador Anterior Cervical Plate System (K091926 and K143576) DePuy Synthes Vectra Anterior Cervical Plate System (K031276)

Implant Materials

Material:	Standard:
Ti-6Al-4V	ASTM F136-13

Technological Characteristics:

There are no technological characteristics that raise new issues of safety or effectiveness.

Assessment of performance data:

The AXIS Orthopaedics Anterior Cervical Plate system was designed as an adjunct to fusion in the cervical spine. The objective of this testing was to demonstrate that the subject AXIS device is equivalent to a predicate device with respect to testing recommended in ASTM F1717-15 and ASTM F543-13e1.

Static compressive bending, static torsion, and fatigue compression testing was performed per ASTM F1717-15 and demonstrated that the subject plate performed equivalently to the predicate device.

An engineering comparison has been provided (Appendix A) that shows a geometric comparison between the subject AXIS device and a mechanical predicate (Exactech Ambassador). Additionally, the subject screws performed sufficiently to pass the evaluation criteria set forth in the protocol that was derived from the applicable ASTM standard.

Conclusion:

Based on the above information, it can be concluded that the subject device is substantially equivalent with respect to its mechanical performance, to the mechanical predicate.

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.