The Southern Spine C Fuse™ Cervical Intervertebral Body Fusion System is intended for single level spinal fusion procedures in skeletally mature patients with degenerative disc disease ("DDD") of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The C-Fuse device is to be implanted via an anterior approach at the C3 to C7 disk levels using autogenous bone graft and is to be combined with supplemental fixation. Patients should have had at least six weeks of non-operative treatment prior to treatment with the device.

Device Description

The C.Fuse Cervical Intervertebral Body Fusion System is a cervical interbody fusion device designed to be inserted within the intervertebral disc space in order to provide structural stability and act as an adjunct to spinal fixation. The device is trapezoidal in shape, with machined grooves on the superior and inferior surfaces, along with a hollow center core to accept autogenous bone graft. There are two materials used in the manufacture of the Southern Spine C-Fuse Cervical Intervertebral Body Fusion System devices which are the Zeniva® ZA-500 (PEEK) under ASTM F2026 and Tantalum Wire Type R05400 under ASTM F560. There is instrumentation for implantation and a sterilization trav for steam sterilization. The implants are non-sterile and single use. The instrumentation is non-sterile and reusable.

AI/ML Overview

The provided text describes the C-Fuse™ Cervical Intervertebral Body Fusion System, a cervical interbody fusion device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria in a clinical study.

Therefore, the information you requested regarding acceptance criteria and a study proving device performance in the context of AI/machine learning is not applicable to this document. This device is a physical medical implant, and its performance is evaluated through material testing and mechanical standards.

Here's why the requested information cannot be extracted from this document:

Acceptance Criteria and Reported Device Performance (Table): This document does not establish specific performance metrics (like accuracy, sensitivity, or specificity) that would be relevant for an AI/ML device. Instead, it refers to compliance with material and mechanical testing standards.
Sample Size for Test Set and Data Provenance: This information is relevant for studies involving data analysis, typically in AI/ML. The C-Fuse system is a physical implant; its evaluation involves mechanical testing, which does not use "test sets" in the AI sense.
Number of Experts and Qualifications: Experts might be involved in evaluating the design or clinical outcomes, but not in establishing ground truth for a "test set" as understood in AI/ML validation.
Adjudication Method: Not applicable for mechanical and material testing.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is specific to diagnostic imaging or AI applications where human readers' performance is compared with and without AI assistance. This is not relevant to a physical spinal implant.
Standalone Performance: While the device has standalone performance in terms of its mechanical properties, it's not "standalone" in the AI sense of an algorithm.
Type of Ground Truth Used: For a physical implant, "ground truth" relates to its material specifications, mechanical integrity, and biological compatibility, not classifications derived from data.
Sample Size for Training Set and How Ground Truth was Established for Training: These concepts are entirely specific to AI/ML model development and are not relevant to the regulatory submission for a physical medical device.

Instead, the document details the following studies and compliance:

Study Type: Mechanical and material testing to demonstrate substantial equivalence to predicate devices.
Acceptance Criteria/Standards Met:
- ASTM F2077 (Standard Test Methods for Intervertebral Body Fusion Devices)
- ASTM F2267 (Standard Test Method for Measuring Load-Displacement Properties of Spine Implants in a Corpectomy Model)
- Compliance with 2007 "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" which identifies the above standards.
Tests Performed:
- Static axial testing
- Static compression shear testing
- Dynamic axial testing
- Dynamic compression shear testing
- Static torsion testing
- Dynamic torsion testing
- Static subsidence testing
- Static expulsion testing
Materials Tested: Zeniva® ZA-500 (PEEK) under ASTM F2026 and Tantalum Wire Type R05400 under ASTM F560.
Conclusion: "Testing results support the determination of substantial equivalence for the C-Fuse Cervical Intervertebral Body Fusion System against the predicate devices." This means the device met the mechanical and material performance requirements to be considered sufficiently similar to existing approved devices, implying it passed the tests according to the established standards and guidance.

In summary, this document is for a physical medical device, not an AI/ML-driven device, so the requested information about acceptance criteria and studies for AI/ML is not present.

Summary

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AUG 1 4 2013

Southern Spine LLC Traditional 510(k) - C Fuse™ Cervical Intervertebral Body Fusion System

510(k) SUMMARY

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92.

Submitted By:	Southern Spine LLC487 Cherry Street - Third Street TowerMacon, GA 31201Phone: (478) 745-0000 Fax: (478) 744-9996
Contact Person:	Julie Stephens, President/ConsultantRegulatory Resources Group, Inc.
Date Submitted:	Revised - August 5, 2013

Device Name and Classification:

Trade/Proprietary Name:	C-Fuse™ Cervical Intervertebral Body Fusion System
Common Name:	Cervical Intervertebral Body Fusion System
Classification Name:	Intervertebral body fusion device
Product Code:	ODP
Regulation:	21 CFR 888.3080
Class:	2

Legally Marketed Predicate Device:

Spinal Devices, LLC [Current Name is Amendia, Inc.] - Phenix Cervical Interbody Device (Phenix® CID) - 510(k) # K083167

Lanx, Inc. - Lanx Fusion System (Includes Breckenridge Interbody/VBR Fusion System) -510(k) # K103660

Device Description:

Indications for Use:

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Southern Spine LLC Traditional 510(k) - C·Fuse™ Cervical Intervertebral Body Fusion System

510(k) SUMMARY

Similarities and Differences to the Predicate Devices:

Similarities

The same materials, the same performance standards, and the same indications for use are used in the C.Fuse™ Cervical Intervertebral Body Fusion System and the predicate devices. The C-Fuse and predicate devices include approximately the same size ranges for use in cervical C-3 to C-7 disc levels. The devices all have a hollow center core to accept autogenous bone graft. The C-Fuse and predicate devices provide instrumentation sets and sterilization travs as accessories for use during implantation.

Differences

The PEEK resin and tantalum materials are from different manufacturers than the predicates; however, no issue with biocompatibility was shown with the C·Fuse device. The C-Fuse and the predicate devices have roughly the same device dimensions and characteristics.

Summary of Testing:

The C-Fuse Cervical Intervertebral Body Fusion System was tested to the ASTM F2077 and ASTM F2267 standards as identified in "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Intervertebral Body Fusion Device", Dated June 12, 2007 as appropriate for characterization of intervertebral body fusion devices. Testing included static axial and compression shear testing, dynamic axial and compression shear testing, static and dynamic torsion testing, static subsidence testing, and static expulsion testing.

Substantial Equivalence Conclusions:

The C-Fuse Cervical Intervertebral Body Fusion System has the same intended use and fundamental scientific technology as the predicate devices. The minor differences do not raise any issues of safety or effectiveness. Testing results support the determination of substantial equivalence for the C-Fuse Cervical Intervertebral Body Fusion System against the predicate devices.

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Public Health Service

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

August 14. 2013

Southern Spine, LLC % Regulatory Resources Group, Incorporated Ms. Julie Stephens President/Consultant 111 Laurel Ridge Drive Alpharetta. Georgia 30004

Re: KI30948

Trade/Device Name: C.Fuse™ Cervical Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: June 28, 2013 Received: June 28, 2013

Dear Ms. Stephens:

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 - Ms. Julie Stephens

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erin I. Keith

For

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

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Enclosure

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Indications for Use

510(k) Number (if known): K130948

Device Name: C·Fuse™ Cervical Intervertebral Body Fusion System

Indications for Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

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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.