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510(k) Data Aggregation
(90 days)
T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
The T2TM Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2TM components consist of end caps which must be attached to a T2 XVBR™ expanding centerpiece to form a complete construct. The final construct is to be used with supplemental fixation. The T2 SCEPTOR™ components also serve as a vertebral body replacement device for the same intended use in the thoracolumbar spine. The T2 SCEPTOR™ end caps and endcleats must be attached to a PYRAMESH-C® device to form a complete construct. Both constructs (T2 XVBR™ and T2 SCEPTOR™) must be used with supplemental fixation to form a final construct. Specifically, the construct is to be used with the Medtronic ZPLATE II™ Anterior Fixation System, the DYNA-LOK CLASSIC® Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2TM Spinal System construct is intended to be used with allograft and/or autograft.
The T2 ALTITUDE™ Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar spine (T)-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 ALTITUDE™ Expandable Centerpiece may be used with or without optional modular endcaps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation. Specifically, the construct is to be used with the VANTAGE® Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2 ALTITUDE™ Expandable Corpectomy System is intended to be used with allograft and/or autograft.
The T2 XVBR™ Spinal System is a distractible system. This construct is inserted between two vertebral bodies in the thoracic and/or lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The construct is not intended to be used as a standalone device. The construct is intended to be used with either anterior and/or posterior supplemental spinal fixation systems already cleared for thoracic and lumbar spine stabilization. The T2 XVBR™ expandable centerpiece is made of titanium alloy. cobalt chrome, and nitinol. The T2 XVBR™ Titanium Alloy end caps are attached to the T2 XVBR™ expandable centerpiece to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy. The T2 XVBR™ Spinal System is available in multiple diameters and heights to accommodate the patient's anatomical requirements.
The T2 ALTITUDE™ Expandable Corpectomy System is a distractible system. This device is inserted between two vertebral bodies in the thoracic and lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The device may be implanted through a lateral or posterior approach using a minimally invasive technique or implanted through a lateral, posterior or anterior approach through a traditional open technique. The device is not intended to be used as a stand-alone implant. The T2 ALTITUDE™ Expandable Corpectomy System is made of titanium alloy, cobalt chrome, and nitinol. The optional T2 ALTITUDE™ angled end caps may be attached to the T2 ALTITUDE™ expanding centerpiece to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy. The T2 ALTITUDE™ Expandable Corpectomy System is available in multiple diameters and heights to accommodate the patient's anatomical requirements.
This 510(k) summary describes an MRI update for the Medtronic Sofamor Danek T2 XVBR™ Spinal System & T2 ALTITUDE™ Expandable Corpectomy Systems. The submission's purpose is to provide appropriate MRI safety labeling for the devices and instructions for MRI technologists. The devices themselves have not undergone changes in design or specifications.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by adherence to specific ASTM standards for MR Conditional labeling. The "reported device performance" is the conclusion that the devices are "MR Conditional" based on testing against these standards.
| Acceptance Criteria (Standard Adherence) | Reported Device Performance |
|---|---|
| ASTM F2052: Standard test method for measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment. | Subject devices met the criteria to be labeled MR Conditional. This implies magnetic displacement force was within acceptable limits. |
| ASTM F2182: Standard test method for measurement of radio frequency induced heating on or near passive implant during magnetic resonance imaging. | Subject devices met the criteria to be labeled MR Conditional. This implies RF-induced heating was within acceptable limits. |
| ASTM F2213: Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment. | Subject devices met the criteria to be labeled MR Conditional. This implies magnetically induced torque was within acceptable limits. |
| ASTM F2119: Standard test method for evaluation of MR image artifacts from passive implants. | Subject devices met the criteria to be labeled MR Conditional. This implies MR image artifacts were evaluated and deemed acceptable for clinical use, or within specified parameters. |
| ASTM F2503: Standard practice for marking medical devices and other items for safety in the magnetic resonance environment. | Devices are labeled as MR Conditional in accordance with this standard. |
Overall Conclusion: Non-clinical testing in accordance with the listed standards and a risk analysis led to the conclusion that the devices are MR Conditional in 1.5 Tesla and 3.0 Tesla MR environments.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size" in terms of patients or implanted devices for the test set. Instead, the testing was conducted on device components or constructs in a laboratory setting to evaluate their MR compatibility. The provenance of this data is non-clinical laboratory testing as described by the ASTM standards, not patient data (retrospective or prospective). The country of origin for the testing facilities is not explicitly stated, but Medtronic Sofamor Danek, USA Inc. is based in Memphis, Tennessee.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This type of submission (MRI compatibility) typically does not involve human expert adjudication of images or diagnoses to establish "ground truth." The "ground truth" for MR compatibility is established by adherence to physical measurement standards and engineering principles, as defined by the ASTM guidelines. Therefore, no medical experts (e.g., radiologists) were used in this capacity. The "experts" involved would be engineers and physicists performing the standardized tests.
4. Adjudication Method for the Test Set
No human adjudication method (e.g., 2+1, 3+1, none) was used for the test set, as the testing involves objective physical measurements against established ASTM standards, not subjective interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to a submission focused on device MRI compatibility. These studies are used to assess the diagnostic performance of a new imaging modality or AI algorithm, often comparing human reader performance with and without AI assistance. This submission deals with the physical safety requirements of an implant in an MRI environment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This submission is for the MRI compatibility of physical spinal implants, not for an AI algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The Type of Ground Truth Used
The ground truth used is based on:
- Established engineering standards and physical measurements: Specifically, the ASTM standards (F2052, F2182, F2213, F2119, F2503) define the metrics and acceptable limits for magnetic displacement, heating, torque, and artifact generation.
- Risk analysis: A safety assessment is conducted based on these objective measurements to determine if the device poses an acceptable risk in the MR environment.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in this context as this is not an AI/machine learning device. The testing involved physical device samples (implants) and components.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
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