(419 days)
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the TRAVERSE™ 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.
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.
Screws/Connectors
The use of screws is limited to placement in T1-T3 in treating thoracic conditions only.
Screws are not intended to be placed in the cervical spine.
Titanium ATLAS™ Cable used with the TRAVERSE™ Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.
The TRAVERSE™ Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical and/or upper thoracic spine.
The TRAVERSE™ Spinal Fixation System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, 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 systems for labeling limitations.
The TRAVERSE™ Spinal Fixation System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt-chromium-molybdenum alloy. Medical grade titanium, medical grade titanium alloy and/or medical grade cobalt-chromium-molybdenum allov may be used together. Never use titanium alloy and/or cobalt-chromium-molybdenum alloy with stainless steel in the same construct. Lastly, the offset connectors contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.
The TRAVERSE™ Spinal Fixation System is a medical device, and its acceptance criteria are established through performance bench testing to demonstrate substantial equivalence to a legally marketed predicate device.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate) | Reported Device Performance (TRAVERSE™ Spinal Fixation System) |
|---|---|
| Compression fatigue performance | Equivalent or better than GALAXY™ 3.2 Spinal System (K043020) |
| Static compression performance | Equivalent or better than GALAXY™ 3.2 Spinal System (K043020) |
| Static torsion performance | Equivalent or better than GALAXY™ 3.2 Spinal System (K043020) |
Study Proving Device Meets Acceptance Criteria:
The study that proves the TRAVERSE™ Spinal Fixation System meets its acceptance criteria is a performance bench testing study. This study was conducted to demonstrate "substantial equivalence" of the TRAVERSE™ system to the predicate device, the GALAXY™ 3.2 Spinal System (K043020).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of TRAVERSE™ components or configurations tested in the bench performance study. It generally refers to "the results of the testing performed on the TRAVERSE™ Spinal Fixation System."
- Data Provenance: The data is from prospective bench testing conducted for the purpose of this 510(k) submission. The country of origin for the data generation would likely be the location of Medtronic Sofamor Danek USA's testing facilities, which is not explicitly stated but implied to be within the US (Memphis, Tennessee).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the evaluation was based on bench testing against engineering standards and comparison to a predicate device, not on clinical human interpretation of data where "ground truth" would be established by experts.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation was based on bench testing against engineering standards, not on human interpretation or classification that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a bench performance test for mechanical equivalence, not a clinical study involving human readers or patient outcomes, nor one assessing human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device (TRAVERSE™ Spinal Fixation System) is a physical spinal fixation system, not a software algorithm or AI-powered diagnostic tool. The performance evaluation was of its physical characteristics.
7. The Type of Ground Truth Used
The ground truth used for the acceptance criteria was engineering performance standards and the established performance characteristics of the predicate device (GALAXY™ 3.2 Spinal System). The "ground truth" for the new device was its measured mechanical performance in compression fatigue, static compression, and static torsion tests.
8. The Sample Size for the Training Set
This information is not applicable. The TRAVERSE™ Spinal Fixation System is a physical medical device, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this type of medical device evaluation.
§ 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.