The SpineFrontier Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc.

The SpineFrontier® Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).

Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. The system is comprised of devices made of PEEK OPTIMA® HA, with various heights to fit the anatomical needs of a wide variety of patients. The device has raised contours on the superior and inferior surfaces that will resist the device movement following implantation.

The implants are provided in two configurations: straight and lordotic (6°) implant sizes for both configurations are offered in three footprints (12x14mm, 11x17mm) and heights from 5mm - 12mm, in 1mm increments.

The SpineFrontier Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).

The Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device components are supplied non-sterile, are single use, and are fabricated from PEEK-OPTIMA® HA and contain tantalum markers for radiographic visualization.

AI/ML Overview

This document is an FDA 510(k) premarket notification for a medical device called the Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of its own clinical performance against acceptance criteria in the way an AI/ML device would. Therefore, most of the questions about acceptance criteria, sample sizes, ground truth, and expert adjudication are not applicable (N/A) in this context.

Here's an analysis based on the provided text, addressing the questions where information is available or applicable:

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

Acceptance Criteria (Not explicitly stated as such for clinical performance, but implied through substantial equivalence to predicate devices for mechanical properties)	Reported Device Performance (from "PERFORMANCE DATA")
Mechanical integrity for intended use (e.g., sufficient strength to withstand spinal loads)	The device underwent mechanical testing according to ASTM standards (F2077, F2267, Draft Standard F-04.25.02.02) for static axial compression, torsion, compressive shear, subsidence, expulsion, and dynamic axial compression and torsion. The device also underwent material characterization, including biocompatibility (ISO 10993) and retention of HA and mechanical performance after artificial aging.
Biocompatibility	Biocompatibility of PEEK-OPTIMA® HA Enhanced per ISO 10993, including an in-bone study using a large animal model and fusion assessment.
	Conclusion: "The results of this non-clinical testing show that the strength of the Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

2. Sample sized 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: The document describes non-clinical performance testing (mechanical and material characterization). It does not specify sample sizes for these tests, which are typically determined by engineering standards rather than statistical clinical trial sample size calculations.
Data provenance: N/A. The data is from laboratory performance testing, not human patient data.
Retrospective or prospective: N/A. This refers to a study design on human subjects, which is not applicable here.

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)

N/A. This device is an implant, and its performance is evaluated through mechanical testing and material characterization, not by human experts establishing ground truth for diagnostic imaging or similar.

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

N/A. No human adjudication is involved in the performance testing of this device type.

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

N/A. This is not an AI/ML medical device, and therefore, an MRMC study is not relevant.

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

N/A. This is not an AI/ML medical device.

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

For mechanical testing, the "ground truth" is defined by the physical properties and performance metrics established by industry standards (e.g., ASTM F2077, F2267).
For material characterization and biocompatibility, the "ground truth" is established by relevant ISO standards (e.g., ISO 10993) and scientific principles, potentially including animal studies for in-bone assessment.

8. The sample size for the training set

N/A. This is not an AI/ML device, so there is no "training set."

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

N/A. This is not an AI/ML device.

Summary

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines connecting them. The profiles are arranged in a way that suggests unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

October 20, 2014

SpineFrontier, Incorporated % Meredith L. May, MS, RAC Empirical Consulting, LLC 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K142026

Trade/Device Name: Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: July 23, 2014 Received: July 25, 2014

Dear Ms. May:

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.

Ronald DAJean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

K142026 Page 1 of 2

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement on last page.
-------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------

Indications for Use

510(k) Number (if known)	K142026
Device Name	Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device
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)

PSC Publishing Services (301) 443-6740 EF

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

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."

FORM FDA 3881 (9/13)

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

510(K) SUMMARY

Submitter's Name:	SpineFrontier Inc.
Submitter's Address:	500 Cummings Center, Suite 3500Beverly, MA 01915, U.S.A.
Submitter's Telephone:	978.232.3990 x116
Contact Person:	Meredith L. May MS, RACEmpirical Consulting LLC719.337.7579
Date Summary was Prepared:	October 8, 2014
Trade or Proprietary Name:	Arena-C® HA PEEK Cervical Intervertebral Body FusionDevice
Common or Usual Name:	Intervertebral Fusion Device With Bone Graft, Cervical
Classification:	Class II per 21 CFR §888.3080
Product Code:	ODP

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

Indications for Use

{5}------------------------------------------------

The SpineFrontier Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).

The indications for use for the Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is identical to that of the Arena-C® Cervical Intervertebral Body Fusion System (K113518).

TECHNOLOGICAL CHARACTERISTICS

The SpineFrontier Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device was shown to be substantially equivalent to predicate devices through comparison of indications for use, function, operating principles, and materials. Specifically the following characteristics were compared between the subject and predicates:

Indications for Use ●
Structural support mechanism ●
Materials of manufacture ●

Table 5-1 Primary Predicate Device
------------------------------------	--

510k Number	Trade or Proprietary or Model Name	Manufacturer
K113518	Arena-C Cervical Intervertebral Body Fusion System	SpineFrontier

Table 5-2 Additional Predicate Devices

510k Number	Trade or Proprietary or Model Name	Manufacturer
K090064	Interbody Fusion System (Copperhead)	Eminent Spine
K110733	Daytona Anterior Cervical Cage	SpineNet

{6}------------------------------------------------

PERFORMANCE DATA

The Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device has been tested in the following test modes:

Mechanical Testing on both the final device and artificially aged device. ●
- Static Axial Compression per ASTM F2077 о
- Static Torsion per ASTM F2077 O
- o Static Compressive Shear per ASTM F2077
- Static Testing in Subsidence per ASTM F2267 O
- Static Testing in Expulsion per ASTM Draft Standard F-04.25.02.02 O
- Dynamic Axial Compression per ASTM F2077 O
- o Dynamic Torsion per ASTM F2077
Material Characterization ●
- o Biocompatibility of PEEK-OPTIMA® HA Enhanced per ISO 10993. o including an in bone study using a large animal model, and fusion assessment.
- o Material characterization, retention of HA and mechanical performance of o PEEK-OPTIMA HA Enhanced following artificial aging.

The results of this non-clinical testing show that the strength of the Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is substantially equivalent to the predicate device.

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.