When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System and FortiCore® are intended for spinal fusion procedures in skeletally mature patients with 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. The Nanovis Intervertebral Body Fusion System and FortiCore® implants 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, the Nanovis Intervertebral Body Fusion System and FortiCore® are intended for spinal fusion procedures in skeletally mature patients with 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 at the involved spinal level(s). The Nanovis Intervertebral Body Fusion System and FortiCore® implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

Device Description

The Nanovis Intervertebral Body Fusion System and FortiCore® consist of implants and related instruments for implantation. The upper and lower aspects of the implants from both systems are open and have a central column to be packed with autogenous bone graft. The FortiCore® implants have an integrated titanium scaffold which assists in securing the implant in the intervertebral space. The devices from both systems are available in a variety of shapes and sizes to accommodate the individual patient anatomy.

AI/ML Overview

This document is a 510(k) summary for the Nanovis Intervertebral Body Fusion System and FortiCore®. It describes the device, its intended use, and the data submitted to demonstrate substantial equivalence to predicate devices. However, it does not contain a typical study design with acceptance criteria and performance metrics for an AI/ML device.

Instead, the performance data section describes engineering analyses for a physical medical device. Therefore, I cannot provide the information requested in your prompt as it pertains to an AI/ML device study.

Here's a breakdown of what the document does provide regarding performance and criteria for this non-AI/ML device:

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

The document describes performance data for the physical device, not an AI/ML algorithm.

Acceptance Criteria	Reported Device Performance
Structural performance of modified sizes	Demonstrated substantial equivalence to predicate devices through finite element and dimensional analyses.
Bacterial Endotoxins Test (BET)	Results met the acceptance criterion according to ANSI/AAMI ST72.

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

Not applicable. The performance data section refers to "finite element and dimensional analyses" and a "Bacterial Endotoxins Test (BET)," which are engineering and laboratory tests, not clinical studies with human patient data or test sets in the context of AI/ML.

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)

Not applicable. This is not an AI/ML study involving expert interpretation of data to establish ground truth.

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

Not applicable. This is not an AI/ML study involving adjudication of human or algorithmic outputs.

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

Not applicable. This is not an AI/ML device, and therefore no MRMC study comparing human readers with and without AI assistance was performed.

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

Not applicable. This is a physical intervertebral body fusion system, not a software algorithm.

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

For the engineering analyses, the "ground truth" would be established by validated engineering principles and test standards. For the Bacterial Endotoxins Test, the "ground truth" is meeting the specified endotoxin limits as defined by ANSI/AAMI ST72.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no training set in this context.

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

Not applicable. This is not an AI/ML device; there is no training set ground truth to establish.

In summary: The provided document is for a physical medical device (intervertebral body fusion system) and the performance data presented relates to engineering analyses and laboratory testing, not the evaluation of an AI/ML algorithm. Therefore, many of the questions are not applicable to the content of this specific document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, layered on top of each other. The profiles are white against a dark background.

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

June 28, 2016

Nanovis LLC % Karen Warden, Ph.D. President BackRoads Consulting Incorporated P.O. Box 566 Chesterland, Ohio 44026-2141

Re: K160874

Trade/Device Name: Nanovis Intervertebral Body Fusion System and FortiCore® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 31, 2016 Received: June 2, 2016

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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" (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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K160874

K160874 Page 1 of 1

Device Name

Nanovis Intervertebral Body Fusion System and FortiCore®

Indications for Use (Describe)

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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510(k) Summary

Date:	28 March 2016
Sponsor:	Nanovis Spine, LLC
	5865 East State Rd. 14
	Columbia City, Indiana 46725 USA
	(877) 907-6266
Sponsor Contact:	Matthew Hedrick, CEO & Chief Operating Officer
510(k) Contact:	Karen E. Warden, PhD
	BackRoads Consulting
	PO Box 566
	Chesterland, OH 44026
	Office: 440.729.8457
Trade Names:	Nanovis Intervertebral Body Fusion System and FortiCore®
Common Name:	Interbody fusion device
Device Classification	Class II
Classification Name:	Intervertebral body fusion device
Regulation:	888.3080
Device Product Code:	MAX
Submission Purpose:	To add a TLIF interbody size to the Nanovis Intervertebral Body Fusion PEEKand FortiCore® Systems, to dimensionally modify the Nanovis IntervertebralBody Fusion System tantalum marker and to add a FortiCore® TLIF marker.
Device Description:	The Nanovis Intervertebral Body Fusion System and FortiCore® consist ofimplants and related instruments for implantation. The upper and loweraspects of the implants from both systems are open and have a centralcolumn to be packed with autogenous bone graft. The FortiCore® implantshave an integrated titanium scaffold which assists in securing the implant inthe intervertebral space. The devices from both systems are available in avariety of shapes and sizes to accommodate the individual patient anatomy.
Indications for Use:	When used as a cervical intervertebral body fusion device, the NanovisIntervertebral Body Fusion System and FortiCore® are intended for spinalfusion procedures in skeletally mature patients with degenerative discdisease (defined as neck pain of discogenic origin with degeneration of thedisc confirmed by history and radiographic studies) at one spinal level fromC2-T1. These patients should have had at least six weeks of non-operativetreatment. The Nanovis Intervertebral Body Fusion System and FortiCore®implants are to be used with autogenous bone graft and in combination withsupplemental fixation indicated for cervical fusion procedures.When used as a lumbar intervertebral body fusion device, the NanovisIntervertebral Body Fusion System and FortiCore® are intended for spinalfusion procedures in skeletally mature patients with degenerative discdisease (defined as discogenic back pain with degeneration of the discconfirmed by history and radiographic studies) at one or two contiguousspinal levels from L2-S1. These patients should have had six months ofnonoperative treatment. These patients may have had a previous non-fusionspinal surgery and/or may have up to Grade 1 spondylolisthesis orretrolisthesis at the involved spinal level(s). The Nanovis Intervertebral BodyFusion System and FortiCore® implants are to be used with autogenousbone graft and in combination with supplemental fixation indicated for lumbarspinal fusion procedures.
Materials:	The Nanovis Intervertebral Body Fusion System implants are available inpolyetheretherketone (PEEK- OPTIMA® LT1, Invibio® as described by ASTMF2026) and titanium alloy (Ti-6Al-4V ELI as described by ASTM F136). ThePEEK devices incorporate a tantalum marker per ASTM F560.FortiCore® devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio®) as described by ASTM F2026. The integratedscaffold (BioSync-Ti, Sites Medical) is manufactured from CP titanium asdescribed by ASTM F67. The FortiCore® devices also incorporate a tantalummarker per ASTM F560.
Primary Predicate:	Nanovis Intervertebral Body Fusion System (Nanovis LLC, K110442)
Additional Predicate:	FortiCore® (Nanovis LLC, K140280)
	Eminent Spine Interbody Fusion System (Eminent Spine, K090064)
Performance Data:	Finite element and dimensional analyses of the modified NanovisIntervertebral Body Fusion and FortiCore® devices were performed. Theresults demonstrated the performance of the modified Nanovis IntervertebralBody Fusion System and modified FortiCore devices are substantiallyequivalent to the predicate devices.In addition, the Bacterial Endotoxins Test (BET) was performed according toANSI/AAMI ST72 and the device results met the acceptance criterion.
TechnologicalCharacteristics:	The modified Nanovis Intervertebral Body Fusion System and FortiCore®possess technological characteristics similar to the predicate devices. Theseinclude:performance (as described above), basic design (hollow structural frame), implant grade materials (PEEK polymer, tantalum and/or titanium), and sizes (widths, lengths and heights are within the range(s) offered by the predicates). Therefore the fundamental scientific technology of the Nanovis IntervertebralBody Fusion System and FortiCore devices is similar to previously cleareddevices.
Conclusion:	The Nanovis Intervertebral Body Fusion System and FortiCore® possess thesame intended use and similar technological characteristics as the predicatedevices. Therefore the Nanovis Intervertebral Body Fusion System andFortiCore® are substantially equivalent to legally marketed predicates.

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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.