The Ayers Rock Cervical interbody fusion system is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. These patients should have had 6 weeks of non-operative treatment. The Ayers Rock Cervical interbody fusion devices are to be used with autogenous bone graft and implanted via an open, anterior approach. The Ayers Rock Cervical interbody fusion system is to be used with supplemental fixation.

Device Description

The Avers Rock Cervical interbody fusion system consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Ayers Rock Cervical interbody fusion system is manufactured from PEEK-OPTIMA® LT1 polymer and contains tantalum radiopaque markers. The Ayers Rock Cervical interbody fusion system is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for the "Ayers Rock Cervical interbody fusion system." It describes the device, its indications for use, and the testing performed to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to predicate devices through mechanical testing. The specific performance requirements are derived from established ASTM standards and an industry norm.

Acceptance Criteria (Standard)	Reported Device Performance
Static Compression (ASTM F2077-14)	Met original performance requirements
Static Compression Shear (ASTM F2077-14)	Met original performance requirements
Static Torsion (ASTM F2077-14)	Met original performance requirements
Dynamic Compression (ASTM F2077-14)	Met original performance requirements
Dynamic Compression Shear (ASTM F2077-14)	Met original performance requirements
Dynamic Torsion (ASTM F2077-14)	Met original performance requirements
Subsidence (ASTM F2267-04, reapproved 2011)	Met original performance requirements
Expulsion testing (recognized industry norm)	Met original performance requirements
Bacterial Endotoxin Testing (USP34 and NF 29)	Performed (implies met, as no issues were reported that would prevent 510(k))

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

The document does not explicitly state the sample size for each specific mechanical test (e.g., number of devices tested for static compression). It also does not mention the data provenance in terms of country of origin or whether the study was retrospective or prospective, as this is a materials/mechanical performance study, not a clinical study involving human subjects or medical 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 type of device (interbody fusion system) in a 510(k) submission based on mechanical testing is established by adherence to recognized industry standards (ASTM) and a "recognized industry norm" for expulsion testing. Expert consensus on medical imaging or clinical outcomes is not relevant for this type of testing.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human interpretation of data where adjudication methods like 2+1 or 3+1 would be used. The acceptance is determined by meeting the specified mechanical and material performance criteria defined by the standards.

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 a study involving human readers or AI. It is a mechanical performance study of an intervertebral body fusion device.

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

Not applicable. This is not an algorithm or AI-driven device. It is a physical medical implant.

7. The Type of Ground Truth Used

The ground truth used for this study is based on established engineering and material science standards and recognized industry norms. Specifically:

ASTM F2077-14: Standard Test Methods for Intervertebral Body Fusion Devices.
ASTM F2267-04 (reapproved 2011): Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression.
USP34 and NF 29: United States Pharmacopeia and National Formulary standards for bacterial endotoxin testing.
Recognized industry norm: For expulsion testing.

These standards define the expected performance characteristics for interbody fusion devices.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its performance is evaluated through direct mechanical and material testing.

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

Not applicable, as there is no "training set" for this type of device and study. The "ground truth" (i.e., acceptable performance levels) for the mechanical testing is established by the specified ASTM standards and industry norms.

Summary

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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 an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces suggesting community and support.

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

January 12, 2017

Spineway % Tamala Wampler Regulatory and Ouality Consultant Novus Management Group, LLC. 6686 Dimmick Road West Chester, Ohio 45069

Re: K162694

Trade/Device Name: Ayers Rock Cervical interbody fusion system Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: December 14, 2016 Received: December 19, 2016

Dear Ms. Wampler:

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,

Vincent J. Devlin -S

for 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) K162694 Device Name

Ayers Rock Cervical interbody fusion 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)

FORM FDA 3881 (9/13)

Page 1 of 2

PSC Publishing Services (301) 443-6740 ER

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510(K) SUMMARY

Submitter's Name:	Spineway
Submitter's Address:	7 Allee Moulin BergerEcully France 69130
Submitter's Telephone:	+33(0)4 72 77 01 52
Company Contact Person:	Mr. Nicolas RothRA/QA Manager
Contact Person:	Tamala J. WamplerNovus Management Group, LLC.513-593-4944
Date Summary was Prepared:	12/13/2016
Trade or Proprietary Name:	Ayers Rock Cervical interbody fusion system
Common or Usual Name:	Intervertebral body fusion device
Classification:	Class II per 21 CFR §888.3080
Product Code:	ODP
Classification Panel:	Division of Orthopedic Devices
Panel Code:	87

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The subject device is substantially equivalent to the predicate devices. The subject device is equivalent to the predicates in regards to technological characteristics including design, indication for use, intended use, material composition, and function.

PREDICATES

Ayers Rock Cervical interbody fusion system is made PEEK-OPTIMA® LT1. The subject and predicate devices have identical technological characteristics. Specifically, the following characteristics are identical between the subject and predicates:

Indications for Use (identical) ●
Materials of manufacture (identical)
Structural support mechanism (identical) ●

Table 5-1 Predicate Devices

510kNumber	Trade or Proprietary orName	Model	Manufacturer	Type
K112801	Ayers Rock		Qualgenix	Primary
K161407	Ascential IBD PEEK Spacer		Stryker Spine	Additional

PERFORMANCE TESTING

The Avers Rock Cervical interbody fusion system was evaluated to demonstrate equivalence to the predicate devices. Mechanical testing, which characterized the mechanical performance and fatigue endurance to show the original performance requirements for Static Compression, Static Compression Shear, Static Torsion, Dynamic Compression, Dynamic Compression Shear and Dynamic Torsion per ASTM F2077-14, Subsidence per ASTM F2267-04 (reapproved 2011) and Expulsion testing per a recognized industry norm were met. No clinical testing was performed. Bacterial endotoxin testing per USP34 and NF 29.

CONCLUSION

The Avers Rock Cervical interbody fusion system has been tested per ASTM F2077 in Static Compression, Static Compression Shear, Static Torsion, Dynamic Compression, Dynamic Compression Shear, Dynamic Torsion and ASTM F2267 Subsidence as well as expulsion testing and were considered substantially equivalent to other legally marketed devices. The subject Ayers Rock Cervical interbody fusion system has similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The overall technology characteristics lead to the conclusion that the Ayers Rock Cervical interbody fusion system is substantially equivalent to the 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.