(82 days)
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.
| Category | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | - ASTM F2077 (Test Methods For Intervertebral Body Fusion Devices) | The subject devices met the pre-determined acceptance criteria for all tests. This demonstrates that the subject implants are substantially equivalent to the predicate Medtronic devices in terms of mechanical performance. |
| - ASTM Draft Standard F-04.25.02.02 (Static Push-out Test Method for Intervertebral Body Fusion Devices) | Specific tests completed: - Static Compression - Compression Fatigue - Static Torsion - Torsion Fatigue - Expulsion | |
| MRI Testing | - Guidance for Industry and FDA Staff - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment | Medtronic believes that the subject implants do not present a new worst case and thus, can justifiably be classified as MR-Conditional. (This implies that the device was evaluated against the guidance and found to meet the criteria for MR-Conditional labeling, although specific numerical performance metrics are not provided in this summary). |
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.
- 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.
- 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.
- Adjudication method for the test set: Not applicable for mechanical or MRI compatibility testing.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device.
- 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.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
- 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.
§ 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.