(29 days)
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
| Acceptance Criteria Category | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Biocompatibility | Meets requirements for permanent implants (>30 days) and body-contacting devices. Manufactured from identical materials (Titanium Alloy Per ASTM F136) as predicate devices (K181328, K173125). Manufacturing processes are standard industry practices and identical to predicates 1 and 2. |
| Mechanical Testing | Implants are the same as predicate implants in terms of material, sizes, and intended use. Mechanical testing for predicate implants was conducted in accordance with ASTM F2077 (Test Methods For Intervertebral Body Fusion Devices) and ASTM Draft Standard F-04.25.02.02 (Static Push-out Test Method for Intervertebral Body Fusion Devices). The subject devices do not introduce a new worst-case scenario, implying they meet the same mechanical performance standards as the predicates. |
| Pyrogenicity | Bacterial endotoxin test (LAL test) performed on worst-case subject implants. Confirmed to meet the 20 endotoxin units (EU)/device pyrogen limit specification for general medical devices that are implanted, as outlined in ANSI/AAMI ST72 and USP . |
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.
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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.
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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 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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as there was no clinical test set requiring adjudication.
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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-powered diagnostic tool.
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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.
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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 .
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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.
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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.
§ 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.