When used as a cervical intervertebral body fusion device, FortiCore™ is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. FortiCore™ devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.
When used as a lumbar intervertebral body fusion device, FortiCore™ is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). FortiCore™ devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

Device Description

FortiCore™ consists of implants and instruments for implantation.
The upper and lower aspects of the implant are open and have an integrated titanium scaffold which assists in securing the implant in the intervertebral space. The devices are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called FortiCore™. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specified acceptance criteria and performance metrics. Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, study design, expert involvement, or sample sizes related to clinical performance.

The "Performance Data" section (page 4) refers to mechanical testing of the device, not a study of its clinical performance in patients.

Here's a breakdown of what can be extracted from the document and why other information is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated for clinical performance. The document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing.
Reported Device Performance: The document states: "The mechanical test results demonstrate that the FortiCore device performance is substantially equivalent to the predicate devices."
- Mechanical Tests Performed:
  - Static and dynamic compression (according to ASTM F2077)
  - Static and dynamic torsion (according to ASTM F2077)
  - Subsidence testing (according to ASTM F2267)
  - Shear and tension testing (according to ASTM F1044 and F1147, respectively) to evaluate the metal-polymer interface.

This document does not contain information about:

Sample size used for the test set or its data provenance.
Number of experts or their qualifications for establishing ground truth.
Adjudication method for a test set.
Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
Standalone (algorithm-only) performance. This is a medical implant, not an AI/software device.
Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
Sample size for the training set.
How the ground truth for the training set was established.

Reason for Missing Information:

The document is a 510(k) submission to the FDA. The primary purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" in terms of its intended use and technological characteristics to a legally marketed "predicate" device. This typically involves:

Comparing indications for use.
Comparing technological characteristics (materials, design, performance specifications).
Conducting non-clinical performance testing (like the mechanical tests mentioned here) to show the new device performs at least as well as the predicate for relevant characteristics.

A 510(k) does not typically require extensive clinical trials with human subjects, setting acceptance criteria for clinical performance metrics (like sensitivity/specificity for diagnostic devices or specific clinical outcomes for therapeutic devices), or rigorous ground truth establishment as would be seen in studies designed to prove de novo safety and effectiveness or for AI/ML device evaluations. The mechanical testing described here is to ensure the device's physical properties are safe and comparable to established devices.

Summary

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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 caduceus symbol, which is a staff with two snakes coiled around it. To the left of the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.

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

September 5, 2014

Nanovis. LLC % Karen E. Warden, Ph.D. BackRoads Consulting, Incorporated 8202 Sherman Road Chesterland, Ohio 44026

Re: K140280

Trade/Device Name: FortiCore™ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: August 1, 2014 Received: August 6, 2014

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 (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 - Karen E. Warden, Ph.D.

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/Resourcesfor You/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#Alean -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

510(k) Number (if known)

K140280

Device Name FortiCore™

Indications for Use (Describe)

When used as a cervical intervertebral body fusion device, FortiCore™ is intended for spinal fusion procedures in skeletally nature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the discorv and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. FortiCore™ devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.

When used as a lumbar intervertebral body fusion device, FortiCore™ is intended for spinal fusion procedures in skeletally mature patients with degenerative disc discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). FortiCore™ devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

Type of Use (Select one or both, as applicable)

区 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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Section 8 - 510(k) Summary

Date:	31 January 2014
Sponsor:	Nanovis, 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:	FortiCore™
Common Name:	Interbody fusion device
Device Classification	Class II
Classification Name:	Intervertebral body fusion device
Regulation:	888.3080
Device ProductCodes:	ODP, MAX
Device Description:	FortiCore™ consists of implants and instruments for implantation.The upper and lower aspects of the implant are open and have anintegrated titanium scaffold which assists in securing the implant inthe intervertebral space. The devices are available in a variety ofsizes to accommodate the individual anatomic and clinicalcircumstances of each patient.
Intended Use:	When used as a cervical intervertebral body fusion device,FortiCore™ is intended for spinal fusion procedures in skeletallymature patients with degenerative disc disease (defined as neck painof discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies) at one spinal level from C2-T1.These patients should have had at least six weeks of non-operativetreatment. FortiCore™ devices are to be used with autogenous bonegraft and in combination with supplemental fixation indicated forcervical fusion procedures.When used as a lumbar intervertebral body fusion device,FortiCore™ is intended for spinal fusion procedures in skeletallymature patients with degenerative disc disease (defined asdiscogenic back pain with degeneration of the disc confirmed byhistory and radiographic studies) at one or two contiguous spinallevels from L2-S1. These patients should have had six months ofnonoperative treatment. These patients may have had a previousnon-fusion spinal surgery and/or may have up to Grade 1spondylolisthesis or retrolisthesis at the involved spinal level(s).FortiCore™ devices are to be used with autogenous bone graft andin combination with supplemental fixation indicated for lumbar spinalfusion procedures.
Materials:	FortiCore devices are manufactured from polyetheretherketone(PEEK-OPTIMA® LT1, Invibio®) as described by ASTM F2026. Theintegrated scaffold (BioSync-Ti, Sites Medical) is manufactured fromCP titanium as described by ASTM F67.
Predicate Devices:	Nanovis Intervertebral Body Fusion System, (Nanovis LLC,K110442)
	Zeus Lumbar Intervertebral Body Fusion Devices (Amendia,K081614)
Performance Data:	Mechanical testing of the worst case FortiCore™ devices wasperformed according to ASTM F2077 and included static anddynamic compression and static and dynamic torsion. Subsidencetesting according to ASTM F2267 was performed on the worst caseFortiCore devices.
	Shear and tension testing were performed according to ASTM F1044and F1147, respectively, to evaluate the metal polymer interface.The mechanical test results demonstrate that the FortiCore deviceperformance is substantially equivalent to the predicate devices.
TechnologicalCharacteristics:	FortiCore possesses the same technological characteristics as thepredicate devices. These include: performance (as described above), basic design (hollow structural frame), implant grade materials (PEEK polymer and titanium), and sizes (widths, lengths and heights are within the range(s) offered by the predicates).
	Technological characteristics which are different have beensupported with descriptive information and/or performance data.Therefore the fundamental scientific technology of the FortiCoredevices is the same as previously cleared devices.
Conclusion:	FortiCore possesses the same intended use and technologicalcharacteristics as the predicate devices. Therefore FortiCore issubstantially equivalent for its intended use.

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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.