(124 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pre-determined acceptance criteria for various mechanical tests according to ASTM F2077 and ASTM Draft Standard F-04.25.02.02. | The subject devices met the pre-determined acceptance criteria for all tests. |
| MRI compatibility established in accordance with "Guidance for Industry and FDA Staff – Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." | The subject Ø13mm centerpieces are identical in material and dimensions to Predicate 6 (K173125), which was previously cleared for MRI compatibility. Therefore, they are justifiably classified as MR-Conditional. |
| Safety profile equivalent to predicate devices for cervical use. | A clinical literature review was performed, and it was determined that the safety profile for cervical use is equivalent to predicate devices. |
Details on the "Study" (Device Performance Testing)
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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.
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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).
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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.
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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.
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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.
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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.
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The sample size for the training set: Not applicable. This device does not use an AI algorithm that requires a training set.
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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.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.