The FortiBridge™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis or scoliosis), pseudarthrosis or failed previous fusion.

Device Description

The FortiBridge™ System consists of implants and instruments for implantation. It is an anterior cervical plate and screw system which includes fixed and variable screws having standard, self-drilling or self-tapping tips, and one- through four-level plates. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.

AI/ML Overview

The provided text describes the FortiBridge™ Anterior Cervical Plate System, a medical device, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria related to an AI/ML algorithm or software.

The document is a 510(k) summary for a spinal implant system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical testing and comparison of design, materials, and intended use, rather than a clinical study evaluating an AI/ML system's performance.

Therefore, many of the requested items cannot be answered from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable for AI/ML device. The document discusses the "performance" in the context of technological characteristics of a spinal implant system, not an AI/ML algorithm. It states: "These include: performance (as described above), basic design (plate and screw system), implant grade materials (titanium alloy), and sizes (dimensions are within the range(s) offered by the predicates)." No specific numerical acceptance criteria or reported performance results in terms of sensitivity, specificity, AUC, etc., are provided.

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

Not applicable for AI/ML device. This information is not relevant to a 510(k) submission for an orthopedic implant. The focus is on mechanical testing and material properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable for AI/ML device. There is no mention of experts establishing a "ground truth" in the context of an AI/ML algorithm for this spinal implant.

4. Adjudication Method for the Test Set:

Not applicable for AI/ML device. No adjudication method is described as this is not an AI/ML study.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is not mentioned as it is irrelevant for a spinal implant device's 510(k) submission.

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

Not applicable. The device is a physical spinal implant, not an algorithm.

7. The Type of Ground Truth Used:

Not applicable for AI/ML device. The "ground truth" for this device would relate to engineering specifications, material standards (e.g., ASTM F136 for titanium alloy), and biomechanical testing results, not clinical outcomes for an AI/ML system.

8. The Sample Size for the Training Set:

Not applicable for AI/ML device. There is no training set for a physical implant.

9. How the Ground Truth for the Training Set was Established:

Not applicable for AI/ML device.

Summary based on the provided text:

The provided document is a 510(k) summary for the FortiBridge™ Anterior Cervical Plate System. It describes the device, its intended use, materials, and predicate devices. The primary method for demonstrating that the device meets regulatory requirements (substantial equivalence) is by showing it has the "same intended use and technological characteristics as the predicate devices." This includes demonstrating similar performance characteristics through engineering principles, material science, and mechanical testing, which is typical for physical orthopedic implants. The document does not pertain to an AI/ML-driven device or study.

Summary

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

April 10, 2015

Nanovis Spine LLC % Karen Warden, Ph.D. President Backroads Consulting, Incorporated P.O. Box 566 Chesterland. Ohio 44026

Re: K143706

Trade/Device Name: FortiBridge™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: March 16, 2015 Received: March 17, 2015

Dear Dr. Warden:

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

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Page 2 - Karen Warden, Ph.D.

(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 (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" (21CFR 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,

Mark N. Melkerson -S

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K143706

Device Name

FortiBridge™ Anterior Cervical Plate System

Indications for Use (Describe)

The FortiBridge™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fision for the treatment of disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis or scoliosis), pseudarthrosis or 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)

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)

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510(k) Summary

Date:	26 December 2014
Sponsor:	Nanovis Spine, LLC5865 East State Rd. 14Columbia City, Indiana 46725 USA(877) 907-6266(260) 625-3834
Contact Person:	Matthew Hedrick, CEO & Chief Operating Officer
Trade Name:	FortiBridge™ Anterior Cervical Plate System
Common Name:	Anterior cervical plate system
Device Classification	Class II
Classification Name:	Spinal intervertebral body fixation orthosis
Regulation:	21 CFR 888.3060
Device ProductCodes:	KWQ
Device Description:	The FortiBridge™ System consists of implants and instruments forimplantation. It is an anterior cervical plate and screw system whichincludes fixed and variable screws having standard, self-drilling orself-tapping tips, and one- through four-level plates. The implants areavailable in a variety of sizes to accommodate the individualanatomic and clinical circumstances of each patient.
Intended Use:	The FortiBridge™ Anterior Cervical Plate System is intended foranterior screw fixation of the cervical spine (C2 to T1). The system isto be used as an adjunct to fusion for the treatment of degenerativedisc disease (defined as neck pain of discogenic origin with thedegeneration of the disc confirmed by history and radiographicstudies), spondylolisthesis, trauma (i.e., fractures or dislocations),tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis orscoliosis), pseudarthrosis or failed previous fusion.
Materials:	FortiBridge™ implants are manufactured from titanium alloy asdescribed by ASTM F136.
Predicate Devices:	Primary: ATLANTIS® Anterior Cervical Plate System (MedtronicSofamor Danek, USA Inc. – К130640)Additional:Spider Cervical Plating System (X-Spine Systems Inc. – К052292)Cervical Spine Locking Plate (CSLP) (Synthes Spine – K945700)
	Performance Data:
TechnologicalCharacteristics:	FortiBridge™ possesses the same technological characteristics asthe predicate devices. These include:performance (as described above), basic design (plate and screw system), implant grade materials (titanium alloy), and sizes (dimensions are within the range(s) offered by the predicates). Therefore the fundamental scientific technology of the FortiBridge™devices is the same as previously cleared devices.
Conclusion:	The FortiBridge™ Anterior Cervical Plate System possesses thesame intended use and technological characteristics as the predicatedevices. Therefore FortiBridge™ Anterior Cervical Plate System issubstantially equivalent for its intended use.

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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.