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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

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.

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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.

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.

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:

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.

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