A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuseTM system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

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

Device Description

The A-CIFT™ SoloFuse™ consists of a PEEK OPTIMA LT1 spacer with titanium bone screws for intervertebral body fusion. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine. The lordotic and nonlordotic PEEK-OPTIMA® LT1 spacers are provided in heights of 5mm to 12mm with a width of 17mm and depths of 13.5mm and 14mm. The lag and rigid screws are offered in diameters 4.2mm and 4.5mm and lengths of 12mm. The titanium bone screws traverse the PEEK-OPTIMA® LTI interbody device either through the body or a posterior/inferior flange to anchor into the patient's vertebral body, thereby securing the interbody into the final placement location. The cage has endplate teeth for additional fixation, ports for bone graft and an anti-screw backout.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Study that Proves Device Meets Acceptance Criteria
Static Axial Compression Test (ASTM F-2077)	Results show sufficient strength for intended use and legal predicate devices.	Non-clinical testing
Static Compression-Shear Test (ASTM F-2077)	Results show sufficient strength for intended use and legal predicate devices.	Non-clinical testing
Static Torsion Test (ASTM F-2077)	Results show sufficient strength for intended use and legal predicate devices.	Non-clinical testing
Dynamic Axial Compression Test (ASTM F-2077)	Results show sufficient strength for intended use and legal predicate devices.	Non-clinical testing
Dynamic Compression-Shear Test (ASTM F-2077)	Results show sufficient strength for intended use and legal predicate devices.	Non-clinical testing
Dynamic Torsion Test (ASTM F-2077)	Results show sufficient strength for intended use and legal predicate devices.	Non-clinical testing
Subsidence Test (ASTM F-2267 and ASTM F-2077)	Results show sufficient strength for intended use and legal predicate devices.	Non-clinical testing
Expulsion Test (ASTM Draft F-04.25.02.02)	Results show sufficient strength for intended use and legal predicate devices.	Non-clinical testing
Material Biocompatibility (PEEK-OPTIMA® LT1, Tantalum, Titanium Alloy)	Materials have a successful history of use in the spinal implant industry and do not introduce previously unaccepted patient risks.	Material standards (ASTM F2026, ASTM F560-05, ASTM F136) and historical use

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided text describes non-clinical testing on the device itself (mechanical and material tests), not clinical studies involving human patients or data derived from them. Therefore, there is no "test set" in the sense of clinical data or patient samples.

For the mechanical tests, the sample size is not explicitly stated, but it refers to the A-CIFT™ SoloFuse™ device itself undergoing various mechanical tests. The provenance is not explicitly stated as a country of origin for data; however, the testing standards (e.g., ASTM) are international standards often adopted globally. This was not a retrospective or prospective human data study.

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)

This information is not applicable as the studies described are non-clinical mechanical and material tests of the device, not studies requiring expert interpretation of diagnostic images or clinical outcomes to establish ground truth.

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

This information is not applicable as the studies described are non-clinical mechanical and material tests, which do not involve subjective interpretation or adjudication by multiple experts in the context of clinical ground truth.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (intervertebral fusion device), not an AI-assisted diagnostic or treatment planning tool. Therefore, there is no mention of human readers or AI assistance effect size.

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

No, a standalone algorithm-only performance study was not done. This submission is for a physical medical device, not an algorithm.

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

For the mechanical tests, the "ground truth" is established by the specified ASTM standards and material specifications. The device's performance is compared against the requirements and benchmarks set by these established engineering and material standards, rather than clinical ground truth (like pathology or outcomes data).

8. The sample size for the training set

This information is not applicable as the studies described are non-clinical mechanical and material tests of a physical device, and not machine learning or AI models that require training sets.

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

This information is not applicable since there is no training set for an AI model.

Summary

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JAN - 3 2014

K131880 Page 1 of 3

5.510(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
Spine Frontier contactPerson:	Paul SpeidelRegulatory Affairs Manager: 978.232.3991
Prepared by and officialcontact person:	Meredith L. May, MSEmpirical Testing Corp.719.337.7579
Date Summary wasPrepared:	03 January 2014
Trade or Proprietary Name:	SpineFrontier® A-CIFTTM SoloFuse™ CervicalIntervertebral Body Fusion Device
Common or Usual Name:	Intervertebral Fusion Device With Integrated Fixation,CervicalIntervertebral Fusion Device With Bone Graft, Cervical
Classification:	Class II per 21 CFR §888.3080
Product Code:	OVE
Classification Panel:	Orthopedic and Rehabilitation Devices Panel
Predicate Devices:	LDR ROI-C (K091088, K113559)NuVasive CoRoent (K102547)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

SpineFrontier® A-CIFT™ SoloFuse™ Cervical Intervertebral Fusion Device System Abbreviated 510(k)

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INDICATIONS FOR USE

TECHNICAL CHARACTERISTICS

The spacers are manufactured from PEEK-OPTIMA® LT1 (ASTM F2026) and Tantalum (ASTM F560-05) markers. Both materials have a successful history of use in the spinal implant industry and use of it in these devices does not introduce any previously unaccepted patient risks. The LDR ROI-C (K091088. K113559) and NuVasive CoRoent (K102547) are manufactured from PEEK-OPTIMA® LTIand titanium alloy along with Tantalum markers.

The bone screws are manufactured from titanium alloy meeting requirements of ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Titanium alloy has a successful history of use in the spinal implant industry and use of it in these devices does not introduce any previously unaccepted patient risks. The LDR ROI-C (K091088, K113559) and NuVasive CoRoent (K102547) bone screws are also manufactured from titanium alloy.

PERFORMANCE DATA

The A-CIFT™ SoloFuse™ has been tested in the following test modes:

Static Axial Compression (ASTM F-2077) .
Static Compression-Shear (ASTM F-2077) .
Static Torsion (ASTM F-2077) .
Dynamic Axial Compression (ASTM F-2077) .
Dynamic Compression-Shear (ASTM F-2077) ●
. Dynamic Torsion (ASTM F-2077)
Subsidence (ASTM F-2267 and ASTM F-2077) .
Expulsion (ASTM Draft F-04.25.02.02) .

The results of this non-clinical testing show that the strength of the A-CIFT™ SoloFuse™ is sufficient for its intended use and legally marketed predicate devices.

SpineFrontier® A-CIFT™ SoloFuse™ Cervical Intervertebral Fusion Device System Abbreviated 510(k)

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Conclusion

The overall technology characteristics and mechanical performance data lead to the conclusion that the A-CIFT™ SoloFuse™ is substantially equivalent to the predicate device.

SpineFrontier® A-CIFT™ SoloFuse™ Cervical Intervertebral Fusion Device System Abbreviated 510(k)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 3, 2014

SpineFrontier, Incorporated % Empirical Testing Corporation Meredith May, MS, RAC 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K131880

Trade/Device Name: SpineFrontier® A-CIFT™ SoloFuse™ Cervical Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II · Product Code: OVE

Dated: November 26, 2013 Received: November 29, 2013

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

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Page 2 - Meredith May, MS, RAC

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 vours.

Ronald###Jean -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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4. INDICATIONS FOR USE STATEMENT

Device Name: SpineFrontier® A-CIFT™ SoloFusc™ Ccrvical Intervertebral Body Fusion Device

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

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Hwang Ph.D. Division of Orthodedic 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.