When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks
The occipitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine. Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.

Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Connectors
The use of multi-axial screws is limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine. Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine. 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. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

Device Description

The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, 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. See the package inserts of both of those systems for labeling limitations. The purpose of this submission is to add an adjustable Occipitocervical plate to the system. The VERTEX® Reconstruction System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium alloy, and or/cobalt chromium with stainless steel in the same construct. The VERTEX® Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. Some components contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel. To achieve best results, do not use any of the VERTEX® Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another MEDTRONIC document. As with all orthopedic and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.

AI/ML Overview

The provided text is a 510(k) summary for the VERTEX® Reconstruction System, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) summary for a spinal fixation orthosis like the VERTEX® Reconstruction System does not typically include clinical study data with acceptance criteria for device performance based on human reader studies, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies in the way one might expect for a diagnostic AI device.

Instead, for devices like these, "acceptance criteria" and "device performance" are primarily demonstrated through mechanical testing to prove that the new device component (the adjustable Occipitocervical plate) is mechanically equivalent to the predicate device and meets established safety standards for implantable medical devices.

Therefore, many of the requested categories for AI/diagnostic studies are not applicable to this document. I will fill in the relevant information as much as possible based on the provided text.

Acceptance Criteria and Device Performance Study for VERTEX® Reconstruction System (K091365)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Not explicitly stated as numeric targets in text, but implied by "equivalent")	Reported Device Performance (from K091365)
Mechanical Equivalence to Predicate Device	New components (adjustable Occipitocervical plate) must demonstrate equivalent mechanical properties (e.g., strength, fatigue life, stiffness) to predicate VERTEX® Reconstruction System components.	"The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to the testing performed for the predicate VERTEX® Reconstruction System components."
Biocompatibility	Materials must be medical grade and compatible with the human body for implantable use. (Implicit in device description)	Fabricated from medical grade titanium, medical grade titanium alloy, medical grade cobalt chromium, Shape Memory Alloy (Nitinol - NiTi), and silicone adhesive. Explicitly notes compatibility rules (e.g., "Never use titanium alloy, and or/cobalt chromium with stainless steel in the same construct").
Sterility	Device must be sterile for implantation. (Implicit for all implantable devices)	Not explicitly detailed in this summary, but a standard requirement for such devices.
Material Properties	Materials used must meet specified standards for medical grade materials.	Uses "medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium."
Design Intent	The device should function as intended for stabilization and fusion in the occipitocervical, cervical, and thoracic spine.	The system "is intended to provide stabilization to promote fusion" for various spinal conditions.

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

Sample Size for Test Set: Not applicable in the context of clinical data for AI/diagnostic performance. For mechanical testing, specific sample sizes (number of constructs or components tested) would have been used, but these exact numbers are not detailed in the 510(k) summary. These would be found in the full 510(k) submission, not the summary.
Data Provenance: Not applicable for clinical study data. Mechanical testing data would be generated internally by the manufacturer.

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

Not Applicable. This is a medical device, not a diagnostic AI system requiring expert consensus on image interpretation or disease diagnosis for a test set. Ground truth for mechanical testing is based on engineering standards and measurements.

4. Adjudication method for the test set

Not Applicable. See point 3.

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 spinal implant system, not an AI-assisted diagnostic tool.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

For mechanical testing: The ground truth is based on established engineering standards, biomechanical principles, and predicate device performance data. The performance of the new component is compared against these benchmarks and the predicate device to demonstrate equivalence. This would include measurements of parameters like yield strength, ultimate tensile strength, fatigue strength, and stiffness.

8. The sample size for the training set

Not Applicable. This device is not an AI model that requires a training set of data.

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

Not Applicable. See point 8.

Summary of Relevant Information from the K091365 Document:

The K091365 document is a 510(k) summary for a Class II spinal implant. The primary method for demonstrating "acceptance criteria" and "device performance" relies on proving substantial equivalence to existing predicate devices.

The key statement regarding performance is:
"The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to the testing performed for the predicate VERTEX® Reconstruction System components."

This indicates that the "study" demonstrating performance was mechanical testing of the device components (specifically, the added adjustable Occipitocervical plate). The "acceptance criterion" was that these mechanical test results had to be equivalent to those of previously cleared predicate devices or established standards for such implants. The document does not provide details on the specific test parameters, sample sizes, or numerical results of these mechanical tests within this summary, as is typical for 510(k) summaries. These details would be part of the full 510(k) submission to the FDA.

Summary

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K091365 Page 1 of 2

VERTEX® Reconstruction System 510(k) Summary

AUG 0 6 2009

August 2009

Medtronic Sofamor Danek USA I. Company: 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738

Contact:	Melisa Lansky, M.B.A.
	Sr. Regulatory Affairs Specialist

Proposed Proprietary Trade Name: VERTEX® Reconstruction System II.
III. Classification Name(s): Spinal Interlaminal Fixation Orthosis; Class: II; Product Code(s): K WP and Regulation No .: 888.3050
IV. Description: The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, 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. See the package inserts of both of those systems for labeling limitations. The purpose of this submission is to add an adjustable Occipitocervical plate to the system.

The VERTEX® Reconstruction System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium alloy, and or/cobalt chromium with stainless steel in the same construct. The VERTEX® Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. Some components contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.

To achieve best results, do not use any of the VERTEX® Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another MEDTRONIC document. As with all orthopedic and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.

V. Indications for Use:

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K091365 page 2 of 2

Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks

The occipitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.

Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Connectors

The use of multi-axial screws is limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

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. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

Substantial Equivalence: Documentation was provided demonstrating that the VI. VERTEX® Reconstruction System is substantially equivalent to other commercially available posterior fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System in K080805 (S.E. 4/18/08), K082728 (S.E. 1/16/09), and K052734 (S.E. 10/21/05). The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to the testing performed for the predicate VERTEX® Reconstruction System components,
© 2009 Medtronic Sofamor Danek

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G605 Silver Spring, MD 20993-0002

Medtronic Sofamor Danek USA % Ms. Melisa Lansky, M.B.A Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

AUG 0 6 2009

Re: K091365

Trade/Device Name: VERTEX® Reconstruction System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: · May 6, 2009 Received: May 8, 2009

Dear Ms. Lansky:

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.

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 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 - Ms. Melisa Lansky, M.B.A

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson
Director

Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K091365

VERTEX® Reconstruction System Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

When intended as an adjunct to fusion of the occipitocervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks

Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. .

Multi-axial Screws/Connectors

The use of multi-axial screws are limited to placement in TI-T3. The screws are not intended to be placed in the cervical spine. Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_ K0 91365

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.