When intended to promote fusion of the occipitocervical spine, the cervical spine, and the thoracic spine, (Occiput-T3), the TRAVERSE™ OCT Spinal Fixation System is indicated 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 Plate/Rod/Occipital Screws/Hooks: The occipitocervical 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 conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine. The use of the occipitocervical plates and rods requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.

Hooks: The hooks 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 of TI-T3. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable used with the TRAVERSE™ OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.

Device Description

The TRAVERSE™ OCT Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital, cervical and/or upper thoracic spine. The TRAVERSE™ OCT Spinal Fixation System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, plates 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 systems for labeling limitations. The TRAVERSE™ OCT Spinal Fixation System is fabricated from medical grade titanium alloy. Never use titanium alloy with stainless steel in the same construct. The TRAVERSE™ OCT Spinal Fixation System also includes a retaining ring for the multi-axial screws made of Shape Memory Alloy (Nitinol-NiTi). Shape Memory Alloy is compatible with titanium alloy. The offset connectors and multi-axial screw saddle contain elastomeric stakes made of silicone adhesive, and the occipital plates contain nickel-cobalt-chromium-molybdenum alloy coil springs. These materials are commonly used in implantable medical devices. Do not use with stainless steel.

AI/ML Overview

Here's an analysis of the provided text regarding the TRAVERSE™ OCT Spinal Fixation System, focusing on acceptance criteria and study details.

Based on the provided text, the TRAVERSE™ OCT Spinal Fixation System is a mechanical device, not a diagnostic AI system or image-based device. Therefore, the concepts of "acceptance criteria" and "study" as typically applied to AI/diagnostic devices (e.g., performance metrics like sensitivity/specificity, ground truth, expert adjudication, MRMC studies, standalone performance) do not directly apply in this context.

Instead, for such a device, "acceptance criteria" relate to mechanical and material performance standards, and the "study" demonstrating this involves mechanical testing to show substantial equivalence to predicate devices.

Here's how to interpret the request in the context of this device:

Acceptance Criteria and Study for TRAVERSE™ OCT Spinal Fixation System

Given that the TRAVERSE™ OCT Spinal Fixation System is a spinal fixation system, the "acceptance criteria" and "study" described in the 510(k) summary are related to its mechanical performance and material compatibility, rather than diagnostic accuracy. The study aims to demonstrate substantial equivalence to existing, legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category/Metric	Reported Device Performance
Premarket Requirement	Substantial Equivalence to legally marketed devices.
Mechanical Performance	Equivalent to or better than the testing performed for the VERTEX® Reconstruction System's occipital components.
Material Compatibility	Fabricated from medical grade titanium alloy. Retaining ring made of Shape Memory Alloy (Nitinol-NiTi), compatible with titanium alloy. Offset connectors and multi-axial screw saddle contain elastomeric stakes made of silicone adhesive. Occipital plates contain nickel-cobalt-chromium-molybdenum alloy coil springs. Material compatibility (titanium alloy with stainless steel, etc.) implicitly meets internal standards.
Biocompatibility	Materials commonly used in implantable medical devices.
Indications for Use (Safety & Efficacy)	Demonstrated by substantial equivalence to predicate device with established clinical use for indicated conditions (DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors).

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

Test Set: Not applicable in the traditional sense for a mechanical device. The "test set" here refers to the actual TRAVERSE™ OCT Spinal Fixation System components and the predicate devices (VERTEX® Reconstruction System components) used for comparative mechanical testing. The specific number of components or samples tested is not specified in the provided summary.
Data Provenance: The mechanical testing data would be generated in a lab setting, likely by the manufacturer (Medtronic Sofamor Danek USA). There is no mention of country of origin for patient data as this is not a clinical study. It's a retrospective comparison to an existing predicate device's performance data.

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

Not applicable. For a mechanical device, "ground truth" is established through engineering specifications, material standards, and validated mechanical testing protocols, not by expert medical consensus on images or clinical outcomes. The "experts" would be materials scientists and mechanical engineers.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of diagnostic data. For mechanical testing, results are typically quantitative and compared against predefined performance thresholds or predicate device data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. MRMC studies are used to evaluate the impact of a diagnostic tool on human reader performance. This device is a surgical implant, not a diagnostic tool that involves human interpretation of cases.

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

Not applicable. This concept pertains to the performance of an AI algorithm in isolation. The TRAVERSE™ OCT Spinal Fixation System is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

For this mechanical device, the "ground truth" is based on:
- Validated Mechanical Testing Standards: Industry-accepted standards for spinal implant performance (e.g., fatigue, static strength, push-out, pull-out tests).
- Predicate Device Performance Data: Established performance characteristics of the legally marketed VERTEX® Reconstruction System.
- Material Specifications: Compliance with medical-grade material standards (e.g., titanium alloy properties).

8. The Sample Size for the Training Set:

Not applicable. This device does not involve machine learning or an "algorithm" with a training set.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth establishment for it.

Summary of the Study (Mechanical Substantial Equivalence Study):

The core "study" described in the 510(k) summary is a mechanical testing comparative study.

Objective: To demonstrate that the TRAVERSE™ OCT Spinal Fixation System is substantially equivalent to other commercially available posterior occipitocervical fixation systems and pre-enactment devices, specifically citing the VERTEX® Reconstruction System (K052402, K052734) as a predicate.
Methodology: "Mechanical testing was provided." This typically involves laboratory tests conducted on the device components (rods, hooks, screws, plates, connectors) to evaluate their mechanical properties under various simulated physiological loads (e.g., static strength, fatigue, pull-out resistance).
Results: "The results of the testing performed for the TRAVERSE™ OCT Spinal Fixation System occipital components were equivalent to or better than the testing performed for the VERTEX® Reconstruction System occipital components." This statement directly addresses the acceptance criterion of substantial equivalence based on mechanical performance.

In essence, for this specific medical device, the "acceptance criteria" are met by demonstrating that its physical and mechanical properties are either the same as, or superior to, those of a legally marketed, predicate device, thereby ensuring it is as safe and effective for its intended use.

Summary

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TRAVERSE™ OCT Spinal Fixation System 510(k) Summary

I. Company:

December 2006 K062879 Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738

DEC 2 2 2 2 2 2

Contact:

Christine Scifert Group Director, Regulatory Affairs

Proposed Proprietary Trade Name: TRAVERSE™ OCT Spinal Fixation System II.

III. Classification Name(s): Spinal Interlaminal Fixation Orthosis: Spinal Intervertebral Body Fixation Orthosis; Pedicle Screw Spinal System; Orthosis, Spinal Pedicle Fixation, for Degenerative Disc Disease; Class: II; Product Code(s): KWP,MNI; and Regulation No .: 888.3050 and 888.3070

IV. Legally Marketed Devices: VERTEX® Reconstruction System (K052402/K052734)

V. Description: The TRAVERSE™ OCT Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital, cervical and/or upper thoracic spine.
The TRAVERSE™ OCT Spinal Fixation System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, plates 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 systems for labeling limitations.

The TRAVERSE™ OCT Spinal Fixation System is fabricated from medical grade titanium alloy. Never use titanium alloy with stainless steel in the same construct. The TRAVERSE™ OCT Spinal Fixation System also includes a retaining ring for the multi-axial screws made of Shape Memory Alloy (Nitinol-NiTi). Shape Memory Alloy is compatible with titanium alloy. The offset connectors and multi-axial screw saddle contain elastomeric stakes made of silicone adhesive, and the occipital plates contain nickel-cobalt-chromium-molybdenum alloy coil springs. These materials are commonly used in implantable medical devices. Do not use with stainless steel.

VI. Indications for Use: When intended to promote fusion of the occipitocervical spine, the cervical spine, and the thoracic spine, (Occiput-T3), the TRAVERSE™ OCT Spinal Fixation System is indicated 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 Plate/Rod/Occipital Screws/Hooks

The occipitocervical plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the

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K0622879
Page 2 of 2

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.

The use of the occipitocervical plates and rods requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.

Hooks

The hooks 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 of TI-T3. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable used with the TRAVERSE™ OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.

VII. Substantial Equivalence: Mechanical testing was provided demonstrating that the TRAVERSE™ OCT Spinal Fixation System is substantially equivalent to other commercially available posterior occipitocervical fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System (K052402, SE 09/23/05; K052734, SE 10/21/05). The results of the testing performed for the TRAVERSE™ OCT Spinal Fixation System occipital components were equivalent to or better than the testing performed for the VERTEX® Reconstruction System occipital components.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Sofamor Danek % Mr. Edward S. Chin, D.Ph., MBA Group Director, Regulatory and Clinical Affairs 1800 Pyramid Place Memphis, Tennessee 38132

DEC 2 2 2006

Re: K062879

Trade/Device Name: TRAVERSE™ OCT Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, KWP Dated: September 22, 2006 Received: September 26, 2006

Dear Mr. Chin:

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 such 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); 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. Edward S. Chin, D.Ph., MBA

This letter will allow you to begin marketing your device as described in your Section 510(k) rms lot notification. The FDA finding of substantial equivalence of your device to a legally promated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,
Barbara Buell
for

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CONFIDENTIAL

Page 1 _ of _ 1 _

December 2006

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

TRAVERSETM OCT Spinal Fixation System Device Name:

Indications for Use

When intended to promote fusion of the occipitocervical spine, and the thoracic spine, (Occiput-T3), the TRAVERSE™ OCT Spinal Fixation System is indicated 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 Plate/Rod/Occipital Screws/Hooks

The occipitocervical 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 conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.

The use of the occipitocervical plates and rods requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.

Hooks

The hooks 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 of TI-T3. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable used with the TRAVERSE™ OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.

Prescription Use X (Part 21 CFR 801 Subpart D) 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)
(Division Offic

AND/OR

Division of Restorative,
and Neurological Devices

510(k) Number K062874

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.