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Cervical and Thoracolumbar
The T2 Stratosphere™ Expandable Corpectomy System is a vertebral body replacement device intended for use in the thoracic and lumbar spine (TI-L5) and cervical spine (C2-C7). The T2 Stratosphere™ Expandable Corpectomy System is intended for use in skeletally mature patients.

When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectorny System is used to replace a collapsed, damaged, or unstable vertebral body caused by tumor, trauma (i.e. fracture), or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. When used in the cervical spine. the T2 Stratosphere™ Expandable Corpectomy System may not be used with optional modular end caps. When used in the cervical spine at single or two levels, the T2 Stratosphere™ Expandable Corpectomy System is intended to be used with supplemental fixation for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation cleared for use in the cervical spine. When used in the thoracic and lumbar spine, the T2 Stratosphere™ Expandable Corpectomy System is used to replace a collabsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 Stratoshere™ Expandable Corpectorny centerpiece may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in the thoracic and lumbar spine. When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectomy System is intended for use with autograft or allogenic bone graft comprised of cancellous bone graft as an adjunct to fusion. When used in the thoracic and lumbar spine, the 72 Stratosphere™ Expandable Corpectomy System is intended for use with autograft or allograft as an adjunct to fusion. The T2 Stratosphere™ Expandable Corpectory System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical and/or thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

Thoracolumbar
The T2 Stratosphere™ Expandable Corpectory System is a vertebral body replacement device intended for use in the thoracic and lumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 Stratosphere™ Expandable Centerpiece may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in the thoracic and lumbar spine.

The T2 Stratosphere™ Expandable Corpectory System is intended for use with autograft or allograft, as an adjunct to fusion. The T2 Stratosphere™ Expandable Corpectomy System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The T2 STRATOSPHERE™ Expandable Corpectomy System is an adjustable vertebral body replacement device and features a self-adjusting end cap which provides continuous angulation between 0-8° in any direction to accommodate the patient's anatomical requirements.

The T2 STRATOSPHERE™ Expandable Corpectomy may be used in the thoracolumbar and cervical spine. The T2 STRATOSPHERE™ Expandable Corpectomy devices for use in the cervical spine are restricted to 13mm diameter centerpieces. Only the 13mm devices are cleared for both cervical and thoracolumbar region of the spine.

The device is inserted between two vertebral bodies in the thoracolumbar or cervical spine and is expanded to aid in the surgical correction and stabilization of the spine. The device may be implanted through a lateral, oblique, or posterior approach using a minimally invasive technique or implanted through a lateral, oblique, posterior, or anterior approach through a traditional open technique.

The T2 STRATOSPHERE™ Expandable Corpectomy System is intended to be used with supplemental fixation cleared for use in the cervical and thoracolumbar spine. The device is not intended to be used as a stand-alone implant.

The T2 STRATOSPHERE™ Expandable Corpectomy System is made of titanium alloy (TI6A14V) in accordance with ASTM F136 Standard Specification for Wrought Titanium- Aluminium-4 Vanadium ELI Alloy for Surgical Implant Applications. The centerpieces are available in multiple diameters and heights. The system also features modular end caps which are available in various angles and geometries.

The medical device in question is the Medtronic T2 STRATOSPHERE™ Expandable Corpectomy System. It's a vertebral body replacement device used in the thoracic, lumbar, and cervical spine. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and a study to prove performance as would be expected for a novel device or a PMA submission with clinical trials.

The assessment of the acceptance criteria and study proving the device meets them is based on the information provided in the 510(k) summary, which mainly references non-clinical testing performed on predicate devices and biocompatibility testing on the subject device.

Here's the breakdown of the information requested:

Acceptance Criteria and Reported Device Performance

Study Information

The 510(k) summary for the T2 STRATOSPHERE™ Expandable Corpectomy System primarily relies on a demonstration of substantial equivalence to predicate devices, rather than a standalone clinical study with a test set of patients. Therefore, many of the typical clinical study parameters (sample size for test set, expert qualifications, adjudication, MRMC study, standalone performance) are not directly applicable in the way they would be for a de novo or PMA submission.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of a clinical test set. The performance data presented are primarily non-clinical (biocompatibility, mechanical, pyrogenicity).
   • Data Provenance: The biocompatibility and pyrogenicity tests were performed on "worst-case subject implants." The mechanical testing data is "provided in the Predicate 2 (K173125, S.E 12/20/2017) submission" and "testing conducted on the predicate implants satisfies testing requirements for the subject devices." This means the mechanical data is retrospective from previous submissions. Specific country of origin for the studies is not mentioned but is implied to be in compliance with U.S. standards.

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

   • Not applicable as there was no clinical test set requiring expert ground truth establishment for this 510(k) summary. The regulatory review is based on non-clinical data and comparison to predicates.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable as there was no clinical test set requiring adjudication.

4. 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 surgical implant, not an AI-powered diagnostic tool.

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

   • Not applicable. This device is a surgical implant. The performance assessed is mechanical strength, material compatibility, and sterility, which are inherent properties of the device, not an algorithm's output.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For biocompatibility: Standardized material specifications (ASTM F136) and biological evaluation guidelines (FDA's Draft Guidance for ISO-10993).
   • For mechanical properties: Standardized test methods (ASTM F2077, ASTM Draft Standard F-04.25.02.02) that define acceptable mechanical performance for intervertebral body fusion devices.
   • For pyrogenicity: Standardized limits for bacterial endotoxin (20 EU/device) as per ANSI/AAMI ST72 and USP .

7. The sample size for the training set:

   • Not applicable in the context of a clinical training set for this device submission. The device design and manufacturing processes are based on established knowledge and previous predicate devices.

8. How the ground truth for the training set was established:

   • Not applicable. The design and manufacturing are based on engineering principles, materials science, and established regulatory standards for similar devices, rather than a "training set" with ground truth in the AI/clinical study sense.

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The T2 STRATOSPHERE™ Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar spine (T1-L5) and cervical spine (C2-C7). The T2 STRATOSPHERE™ Expandable Corpectomy System is intended for use in skeletally mature patients.

When used in the cervical spine, the T2 STRATOSPHERE® Expandable System is used to replace a collapsed, damaged, or unstable vertebral body caused by tumor, trauma (i.e. fracture), or for reconstruction following corpectorned to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. When used in the cervical spine, the T2 STRATOSPHERE™ Expandable Corpectomy System may not be used with optional modular end caps. When used in the cervical spine at one or two levels, the T2 STRATOSPHERE™ Expandable Corpectomy System is intended to be used with supplemental fixation for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation cleared for use in the cervical spine.

When used in the thoracolumbar spine, the T2 STRATOSPHERE® Expandable System is used to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 STRATOSPHERE™ Expandable Corpectomy System may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in the thoracolumbar spine.

When used in the cervical spine, the T2 STRATOSPHERE™ Expandable Corpectomy System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. When used in the thoracolumbar spine, the T2 STRATOSPHERE™ Expandable Corpectomy System is intended for use with autograft or allograft as an adjunct to fusion. The T2 STRATOSPHERE™ Expandable Corpectomy System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical and/or thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The T2 STRATOSPHERE™ Expandable Corpectomy System is an adjustable vertebral body replacement device and features a self-adjusting end cap which provides continuous angulation between 0-8° in any direction to accommodate the patient's anatomical requirements. The T2 STRATOSPHERE™ Expandable Corpectomy devices for use in the cervical spine are restricted to 13mm diameter centerpieces. The T2 STRATOSPHERE™ Expandable Corpectomy System is made of titanium alloy. This device is inserted between two vertebral bodies in the thoracolumbar or cervical spine and is expanded to aid in the surgical correction and stabilization of the spine. The centerpieces are available in multiple heights.

The system also features modular end caps which are available in various angles and diameters that are only for use in the thoracolumbar spine.

The device is not intended to be used as a stand-alone implant.

The provided text describes the T2 STRATOSPHERE™ Expandable Corpectomy System, a vertebral body replacement device. The document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to predicate devices, rather than a study evaluating an AI device or algorithm in the context of diagnostic accuracy. Therefore, many of the requested categories (e.g., sample size for AI test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this submission.

However, I can extract information related to the device's performance testing which serves as the "study that proves the device meets the acceptance criteria" in this context.

Here's a breakdown of the relevant information:

Acceptance Criteria and Reported Device Performance

Details on the "Study" (Device Performance Testing)

1. Sample size used for the test set and the data provenance: Not explicitly stated as a "sample size" in the context of patients or images, but rather the number of devices or components tested. The provenance is internal testing by Medtronic Sofamor Danek, USA Inc.

   • Test methods and materials: The testing involved mechanical and MRI evaluations of the T2 STRATOSPHERE™ Expandable Corpectomy System devices and components (specifically Ø13mm centerpieces for MRI).
   • Mechanical Tests: Static Compression, Compression Fatigue, Static Torsion, Torsion Fatigue, Expulsion.
   • MRI Testing: Evaluated according to FDA guidance for passive implants.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth here refers to engineering specifications and regulatory standards (ASTM standards and FDA guidance documents).

3. Adjudication method for the test set: Not applicable in the traditional sense of clinical adjudication. The assessment of meeting acceptance criteria is based on direct measurement against defined engineering and regulatory standards.

4. 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 surgical implant, not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used:

   • Mechanical Testing: Engineering specifications and performance requirements derived from ASTM F2077 and ASTM Draft Standard F-04.25.02.02.
   • MRI Compatibility: FDA guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment."
   • Clinical Literature Review (for cervical use): Existing published clinical literature regarding the safety and performance of similar devices.

7. The sample size for the training set: Not applicable. This device does not use an AI algorithm that requires a training set.

8. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) submission for a physical medical device, not an AI/ML powered medical device. Therefore, the "study" described focuses on engineering validation (mechanical and MRI testing) and a literature review to demonstrate substantial equivalence to previously cleared predicate devices, rather than clinical efficacy through traditional comparative studies involving human readers or AI algorithms.

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The T2 STRATOSPHERE™ Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor, or trauma (i.e., fracture). The T2 STRATOSPHERE™ Expandable Centerpiece may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in the thoracolumbar spine.

T2 STRATOSPHERE™ Expandable Corpectomy System is intended for use with autograft or allograft, as an adjunct to fusion. The T2 STRATOSPHERE™ Expandable Corpectomy System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage turnors involving the thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The T2 STRATOSPHERE™ Expandable Corpectomy System consists of centerpieces, modular end caps, and associated instruments. The T2 STRATOSPHERE™ Expandable Corpectomy System is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine for tumor and trauma pathologies.

This is a 510(k) premarket notification for a medical device, specifically the T2 STRATOSPHERE™ Expandable Corpectomy System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with strict acceptance criteria for diagnostic performance. Therefore, the information requested about acceptance criteria for diagnostic device performance (e.g., accuracy, sensitivity, specificity, MRMC studies) is generally not applicable to this kind of submission for a mechanical implantable device.

Instead, acceptance criteria for this device are related to its mechanical performance and safety. The provided text outlines:

1. Table of Acceptance Criteria and Reported Device Performance

The "Acceptance Criteria" for this device are the established standards for mechanical and MRI compatibility, which the device must meet to demonstrate substantial equivalence to its predicate devices. The "Reported Device Performance" confirms that the device met these criteria.

Information Not Applicable or Not Provided in this 510(k) Summary:

The following points are typically relevant for diagnostic devices or devices requiring clinical performance data. They are generally not applicable to a mechanical implantable device seeking 510(k) clearance based on substantial equivalence to a predicate, where mechanical and biocompatibility testing are the primary focus.

2. Sample size used for the test set and the data provenance: Not applicable in the context of diagnostic performance testing. The "test set" here would refer to the mechanical specimens, which are tested in a lab, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on standardized test methods and physical measurements, not expert consensus on medical images or diagnoses.
4. Adjudication method for the test set: Not applicable for mechanical or MRI compatibility testing.
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 is a medical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device's "performance" is based on established engineering standards for mechanical strength, durability, and MRI compatibility. This is demonstrated through in-vitro laboratory testing, not clinical "ground truth" derived from patient outcomes or expert reads.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, for the T2 STRATOSPHERE™ Expandable Corpectomy System, "acceptance criteria and study that proves the device meets the acceptance criteria" refers to the successful completion of rigorous mechanical laboratory testing and MRI compatibility testing in accordance with recognized ASTM standards and FDA guidance, demonstrating that the device performs equivalently to its legally marketed predicate devices. It is not a diagnostic device and therefore the acceptance criteria are not related to diagnostic performance metrics.

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