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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.

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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The T2™ Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2TM components consist of a series of end caps, baskets, and covers 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 IITM Anterior Fixation System, the DYNALOK CLASSIC® Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2™ Spinal System construct is intended to be used with bone graft.

The T2TM Spinal System is a distractible system used in corpectomy procedures. 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 stand alone 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™ expanding cage is made of titanium alloy, cobalt chrome, and nitinol. The T2 XVBR™ end caps, baskets, and covers are attached to the T2 XVBR™ expanding cage to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

T2™ Spinal System constructs may not be used with stainless steel supplemental fixation devices. Titanium constructs comprised from one of the following Medtronic spinal systems or their successors must be used with the T2TM Spinal System.

This document is a 510(k) summary for the T2™ Spinal System, which is a medical device. Based on the provided text, it's not a study proving device performance against acceptance criteria in the typical sense of a clinical or analytical performance study for an AI/diagnostics device. Instead, it's a submission to demonstrate substantial equivalence to previously cleared devices. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This document is a 510(k) submission asserting substantial equivalence to predicate devices, not a performance study against specific acceptance criteria. The "performance" being demonstrated is the T2™ Spinal System's similarity in intended use, technology, and safety/effectiveness to existing devices.

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

Not applicable. No test set or data provenance related to a performance study is described. The submission is based on comparison to predicate devices, material testing, and design specifications.

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

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set

Not applicable. No test set or adjudication method is described.

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 device is a physical spinal implant, not an AI or diagnostic tool.

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

Not applicable. This device is a physical spinal implant, not an algorithm.

7. The type of ground truth used

Not applicable. No ground truth as typically understood for a performance study is described. The basis for clearance is "Substantial Equivalence" to legally marketed predicate devices, meaning the device's design, materials, and intended use are comparable to already approved devices.

8. The sample size for the training set

Not applicable. No training set is described.

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

Not applicable. No training set or ground truth establishment for it is described.

Summary of the K082112 510(k) Pre-market Notification (T2™ Spinal System):

This document is a 510(k) summary for a vertebral body replacement system. The core of this submission is to demonstrate substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their new device is as safe and effective as existing legally marketed devices, based on similarities in intended use, technological characteristics, and performance (often demonstrated through bench testing and material compatibility, though not detailed here).

The FDA's letter (pages {2} and {3}) confirms that a substantial equivalence determination was made, allowing the device to be marketed. This regulatory pathway does not typically involve a clinical performance study with acceptance criteria and a test set like those for AI or diagnostic devices. Instead, the "proof" is in the successful demonstration of equivalence to existing, approved devices.

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The T2TM Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2™ components consist of a series of end caps, baskets, and covers 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 IITM Anterior Fixation System, the DYNALOK CLASSIC® Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2™ Spinal System construct is intended to be used with bone graft.

The T2TM Spinal System is a distractible system used in corpectomy procedures. 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 stand alone 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 TM Spinal System contains an expandable centerpiece, which is made of titanium alloy, cobalt chrome, and nitinol and is available in multiple diameters and heights to accommodate the patient's anatomical requirements. The T2™ Spinal System's end caps, baskets, and covers are attached to the T2TM Spinal System's expandable centerpieces to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

T2TM Spinal System constructs may not be used with stainless steel supplemental fixation devices. Titanium constructs comprised from one of the following Medtronic spinal systems or their successors must be used with the T2TM Spinal System.

The provided text is a 510(k) premarket notification for the MEDTRONIC Sofamor Danek T2TM Spinal System. This document does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The T2TM Spinal System is a physical medical device (a vertebral body replacement system). The 510(k) summary focuses on demonstrating substantial equivalence to previously cleared devices based on material, design, and indications for use, rather than performance metrics from a study as would be relevant for an AI/ML device.

Therefore, I cannot provide the requested information from the given text as it is not relevant to an AI/ML device study.

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