The VERTEX® Reconstruction System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the instability. The VERTEX® Reconstruction System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

Device Description

The subject VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, screws, hooks, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® Cable may be used with this system at the surgeon's discretion.

AI/ML Overview

This document describes the regulatory clearance for the VERTEX® Reconstruction System, a medical device used for spinal immobilization and stabilization. It does not contain information about studies involving AI or machine learning algorithms. Therefore, much of the requested information regarding AI study specifics cannot be extracted from this document.

However, I can provide available information related to the device's acceptance criteria and the non-clinical and retrospective clinical studies used to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria (or demonstrated equivalence) and Reported Device Performance

The document states that the VERTEX® Reconstruction System is substantially equivalent to the predicate AXIS® Fixation System. This means the acceptance criteria are not explicit performance metrics in a classical sense, but rather a demonstration that the new device performs at least as well as, and has similar technological characteristics to, the legally marketed predicate.

Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance (through comparison to predicate)
Design Features (similar)	Substantially equivalent to AXIS® Fixation System
Materials Used (similar)	Substantially equivalent to AXIS® Fixation System
Indications for Use (similar)	Substantially equivalent to AXIS® Fixation System
Surgical Approach (similar)	Substantially equivalent to AXIS® Fixation System
Manufacturing Methods (similar)	Substantially equivalent to AXIS® Fixation System
Sterilization Methods (similar)	Substantially equivalent to AXIS® Fixation System
Mechanical Testing	Demonstrated substantial equivalence:
	- Unblocked Compression Fatigue and Static Compression Testing of Multi-Axial Screws (MAS) - ASTM F1717
	- Semi-Blocked Torsion Fatigue and Static Torsion Testing of Occipital Cervical Module with MAS - ASTM F2706
Retrospective Clinical Outcomes	Demonstrated substantial equivalence to AXIS® Fixation System when used for the stated indications.

Regarding the device's "performance": The document does not provide specific numerical performance metrics (e.g., success rates, complication rates) for the VERTEX® Reconstruction System or the predicate device. Instead, it relies on the concept of substantial equivalence, implying that its performance is comparable to that of the pre-existing, legally marketed device.

2. Sample size used for the test set and the data provenance

Test Set (for clinical data): The document refers to "Retrospective clinical data provided in support of this application along with the published clinical outcomes of additional patients treated with the VERTEX® device for the indications sought." The sample size for the retrospective clinical data is not specified in this document.
Data Provenance: The available clinical data is retrospective. The country of origin is not specified but is implicitly from the locations where the VERTEX® device has been used or studied.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not available in the provided document. As this is a medical device clearance based on substantial equivalence, the "ground truth" for clinical outcomes would typically be based on established medical evaluations, but the specific process and expert involvement are not detailed.

4. Adjudication method for the test set

This information is not available in the provided document.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done as this device does not involve AI or human readers for diagnostic interpretation in the context of the provided regulatory submission.

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

No, a standalone algorithm study was not done as this device is a physical implantable medical device, not an algorithm.

7. The type of ground truth used

For the retrospective clinical data, the "ground truth" would implicitly be the clinical outcomes observed in patients treated with the VERTEX® device, evaluated against the accepted medical standards for spinal fusion and stabilization. However, the specific methodology for establishing this ground truth (e.g., pathology, independent outcomes assessment) is not detailed in the document.

8. The sample size for the training set

This information is not applicable/available as this device is a physical implant and does not involve AI or machine learning models that require training sets.

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

This information is not applicable/available as this device is a physical implant and does not involve AI or machine learning models that require training sets and ground truth.

Summary

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

February 6, 2015

Medtronic Sofamor Danek USA, Incorporated Mr. Lee Grant Distinguished Regulatory Affairs Advisor 1800 Pyramid Place Memphis, Tennessee 38132

Re: K143471

Trade/Device Name: VERTEX® Reconstruction System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: December 1, 2014 Received: December 5, 2014

Dear Mr. Grant:

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

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Page 2 - Mr. Lee Grant

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,

VincentJ. Devlin -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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Indications for Use

510(k) Number (if known) K143471

Device Name VERTEX® Reconstruction System

Indications for Use (Describe)

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)

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FOR FDA USE ONLY

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	VERTEX® Reconstruction System510(k) Summary – K143471November 2014
Company:	Medtronic Sofamor Danek USA1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738
Contact:	Lee GrantDistinguished Regulatory Affairs Advisor
Proprietary Trade Name:	VERTEX® Reconstruction System
Regulatory Identification/Classification:	Orthosis, Cervical Pedicle Screw Spinal FixationProduct Code: NKGUnclassified, Pre-AmendmentSpinal Interlaminar Fixation OrthosisRegulation Number: 888.3050Product Code: KWPClass II

Description: The subject VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, screws, hooks, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® Cable may be used with this system at the surgeon's discretion.

Indications for Use: The VERTEX® Reconstruction System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The VERTEX® Reconstruction System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited

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time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Summary of the Technological Characteristics: The subject VERTEX® Reconstruction System has a similar fundamental scientific technology as the predicate AXIS® Fixation System (primary predicate) and is identical to the VERTEX® Reconstruction System (reference device). The subject device utilizes equivalent surgical approaches, implant materials, surgical instruments and sterilization methods as the predicate AXIS® device.

Identification of Legally Marketed Devices: The subject VERTEX® Reconstruction System is substantially equivalent to the predicate cervical spinal system – the AXIS® Fixation System (primary predicate) cleared by the FDA in K062254 (SE 06/16/08). The subject device is also equivalent to the previously cleared VERTEX® devices most recently cleared in K123906 (SE 04/01/2013) and in K123568 (SE 02/25/13) with respect to the implants used to create the constructs utilized for the indications sought. The earlier VERTEX® Reconstruction System clearances are noted for reference purposes only and not as a predicate device for this application.

Discussion of Supporting Retrospective Clinical Data and Non-Clinical Testing:

Retrospective clinical data provided in support of this application along with the published clinical outcomes of additional patients treated with the VERTEX® device for the indications sought, demonstrates the subject device is substantially equivalent to the AXIS® Fixation System when used to treat the aforementioned indications. Mechanical testing was also provided to support a substantial equivalence determination of the subject VERTEX® Reconstruction System. Testing consisted of the following:

Unblocked Compression Fatigue and Static Compression Testing of Multi-Axial Screws (MAS) -ASTM F1717

Semi-Blocked Torsion Fatigue and Static Torsion Testing of Occipital Cervical Module with MAS – ASTM F2706

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Conclusion: The design features, materials used, indications for use, surgical approach, manufacturing methods and sterilization methods are substantially equivalent to the previously cleared AXIS® Fixation System. The mechanical testing and clinical data provided demonstrate the substantial equivalence of the subject VERTEX® Reconstruction System compared to the predicate AXIS® Fixation System.

Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.