The DIVERGENCE™ anterior cervical plate and bone screw components are intended for anterior interbody screw fixation from C2-T1. The indications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are in the temporary stabilization of the anterior spine during the development of spinal first with: 1) degenerative disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by paiient history and radios), 2) trauma (including fractures). 3) tunors, 4) defined as kyphosis, lordosis, or scoliosis). 5) pseudoarthrosis, and/or 6) failed previous fusions.

"The DIVERGENCE™ anterior cervical cage component is intended to be used for amerior cervical interbody fusion procedures in skeletally mature patients with cervical dise disease at one level from the C2-C3 disc . Cervical disc disease is defined as intractable radior myclopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symplomatic nerve root and/or spinal confirmed by radiographic studies. This cage is to be used in patients who have had six weeks of non-overative treatment. The DIVERGENCE™ cage must be used with supplemental fixation. The DIVERGENCE™ cage is also required to be used with antogenous bone graft and/or allogenic bone graft comprised of cancellous bone grafi and is to be implanted via an open, anterior approach.

When used together, the DIVERGENCE™M components can be used only to treat cervical dise disease.

Device Description

The DIVERGENCE™ Anterior Cervical Fusion System consists of temporary implants (plates and bone screws) intended for anterior screw fixation, and fusion devices (interbody cages) intended to stabilize and promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The DIVERGENCE™ anterior cervical plates and bone screws are available in broad range of size offerings that are intended for anterior screw fixation intended for stabilization use during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The DIVERGENCE™ anterior cervical plate and bone screws are made from titanium allov and are provided sterile.

The DIVERGENCE™ anterior cervical cages available in various widths and heights can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These implants must be used with supplemental fixation. The device is made from medical grade polyetheretherketone (PEEK OPTIMA™), contains titanium alloy wire markers and is provided sterile.

AI/ML Overview

The DIVERGENCE™ Anterior Cervical Fusion System is a medical device subject to regulatory review. The provided text is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to previously cleared predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance data as might be found in a clinical trial report or a comprehensive engineering validation study. As such, the information you're requesting regarding quantitative acceptance criteria and detailed study outcomes (like sample sizes for test/training sets, expert qualifications, MRMC studies, and explicit ground truth definitions) is not explicitly available in this type of summary.

However, based on the text provided, here is how we can interpret and present the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance (Spinal Implants in a Vertebrectomy Model)	Met the pre-determined acceptance criteria for all tests according to ASTM F1717-13.
Mechanical Performance (Intervertebral Body Fusion Devices)	Met the pre-determined acceptance criteria for all tests according to ASTM F2077-11.
Subsidence (Intervertebral Body Fusion Device Under Static Axial Compression)	Met the pre-determined acceptance criteria for all tests according to ASTM F2267-04(2011).
Substantial Equivalence	Demonstrated substantial equivalence to listed predicate devices based on non-clinical test results and supporting documentation.

Explanation of "Acceptance Criteria" in this context:

For a 510(k) submission, "acceptance criteria" are typically defined by the recognized consensus standards (like the ASTM standards cited) and the comparative performance to the predicate device. The device "met the pre-determined acceptance criteria for all tests," which implies that its mechanical performance (strength, stability, resistance to subsidence) was comparable to or better than that of the predicate devices and within the established safety and performance limits set by the standards. The exact quantitative values for these criteria are not disclosed in this summary but would be part of the full submission.

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

Sample Size for Test Set: Not explicitly stated in the 510(k) summary. These tests are typically conducted on a representative number of physical devices according to the specified ASTM standards.
Data Provenance: The tests are non-clinical (laboratory-based mechanical testing) performed to recognized consensus standards (ASTM). No human or animal data is described, so country of origin for clinical data or retrospective/prospective status is not applicable here.

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

This question is not applicable to this type of submission. The "ground truth" for the non-clinical tests is established by the specified ASTM standards and the measurements obtained during the mechanical testing of the physical devices. There are no human experts "establishing ground truth" in the way one would for image interpretation or diagnosis.

4. Adjudication Method for the Test Set

Not applicable. This refers to adjudication of discrepancies in human interpretation, which is not relevant for mechanical testing against standards.

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 a 510(k) for a physical medical implant (spinal fusion system), not a software or AI-powered diagnostic device. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.

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

Not applicable. As above, this is for a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation in this 510(k) is the mechanical performance measured against established ASTM consensus standards and the comparative performance to the predicate devices. The goal is to demonstrate that the device performs mechanically in a manner substantially equivalent to legally marketed devices and meets relevant safety standards.

8. The Sample Size for the Training Set

Not applicable. "Training set" refers to data used to train an algorithm. This is a physical device, and therefore, an algorithmic training set is not relevant.

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

Not applicable, as there is no training set for an algorithm.

Summary

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K140417

JUL 0 9 2014

DIVERGENCE™ Anterior Cervical Fusion System 510(k) Summary

9 July 2014

I. Company:	Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, TN 38132(901) 396-3133
II. Contact:	Shweta SharmaSenior Regulatory Affairs Specialist
III. Proprietary Trade Name:	DIVERGENCETM Anterior Cervical Fusion System
IV. Common Name:	Spinal Intervertebral Body Fixation Appliance, Cervical Intervertebral Fusion Device with Bone Graft
V. Classification Name:	21 CFR 888.3060 - Spinal Intervertebral Body Fixation Orthosis21 CFR 888.3080 - Intervertebral Body Fusion Device
Classification:	Class II
Product Codes:	KWQ, ODP

VI. Product Description:

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stabilization use during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The DIVERGENCE™ anterior cervical plate and bone screws are made from titanium allov and are provided sterile.

VII. Indications for Use:

The DIVERGENCE™ anterior cervical plate and bone screw components are intended for anterior interbody screw fixation from C2-T1. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior spine during the development of spinal fusions in patients with: }) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, or scoliosis), 5) pseudoarthrosis, and/or 6) failed previous fusions.

The DIVERGENCE™ anterior cervical cage component is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This cage is to be used in patients who have had six weeks of non-operative treatment. The DIVERGENCE™ cage must be used with supplemental fixation. The

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DIVERGENCE™ cage is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.

When used together, the DIVERGENCE™ components can be used only to treat cervical disc disease.

VIII. Summary of Technological Characteristics

The subject DIVERGENCE™ Anterior Cervical Fusion System plate and bone screw components have the same fundamental scientific technology as the predicate ZEPHIR® Anterior Cervical System and ATLANTIS® Anterior Cervical System devices. The subject devices are manufactured from the same titanium alloy material as the predicates. The predicate and subject devices are also both anterior screw fixation devices where fixation is provided by bone screws inserted into the vertebral body of the cervical spine.

The subject DIVERGENCE™ Anterior Cervical Fusion System interbody cage component has the same fundamental scientific technology as the predicate ANATOMIC PEEK Cervical Fusion System, CORNERSTONE® PSR Cervical Fusion System, PEEK PREVAIL® Cervical Interbody Device, AFFINITY® Anterior Cervical Cage System and PERIMETER® C spinal system devices. The subject interbody cage is manufactured from the same PEEK and titanium allov material as the predicate devices. The predicate and subject devices are also both interbody devices designed to contain graft material and facilitate a fusion between two vertebral bodies.

IX. Identification of Legally Marketed Predicate Devices Used to Claim Substantial Equivalence

The subject mini plate and bone screws are substantially equivalent to the predicates:

ZEPHIR® Anterior Cervical System (K030327, SE 02/26/03) .
ATLANTIS® Anterior Cervical Plate System (K130640. SE 06/04/13) .

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The subject interbody cage is substantially equivalent to the predicates:

ANATOMIC PEEK Cervical Fusion System (K130177, SE 09/23/13; K112444, . SE 11/15/11)
CORNERSTONE® PSR Cervical Fusion System (K111264, SE 10/12/11) .
. PEEK PREVAIL® Cervical Interbody Device (K113252, SE 1/17/12; K094042, SE 06/30/10)
. AFFINITY® Anterior Cervical Cage System (P000028, Approval Date 07/13/02, down-classified to Class II special controls, Date of Final Order 06/12/07)
. PERIMETER® C Spinal System (K132584, SE 12/04/13; K100967, SE 08/05/11)

X. Brief Discussion of the Non-Clinical Tests Submitted

The subject DIVERGENCE™ Anterior Cervical Fusion System devices were tested in accordance to ASTM F1717-13 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model", ASTM F2077-11 "Test Methods For Intervertebral Body Fusion Devices" and ASTM F2267-04(2011) "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression".

The subject devices met the pre-determined acceptance criteria for all the tests. The test results are provided to demonstrate that the subject devices are substantially equivalent to the predicate devices.

Conclusions Drawn from the Non-Clinical Tests XI.

Based on the non-clinical test results and additional supporting documentation provided in this pre-market notification, the subject devices demonstrated substantial equivalence to the listed predicate devices.

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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, MI) 20993-0002

July 9, 2014

Medtronic Sofamor Danek USA, Incorporated Ms. Shweta Sharma Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

K140417 Re:

Trade/Device Name: DIVERGENCE™ Anterior Cervical Fusion System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ, ODP Dated: June 12, 2014 Received: June 13.2014

Dear Ms. Sharma:

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 cither 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 – Ms. Shweta Sharma

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" (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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ronald P. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K140417

Device Name

DIVERGENCE™ Anterior Cervical Fusion System

Indications for Use (Describe)

When used together, the DIVERGENCE™M components can be used only to treat cervical dise disease.

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

2 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) (Signalure)

Anton E. Dmitriey, PhD Division of Orthopedic Devices

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

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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.