(252 days)
The MediExpand TL Expandable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore the height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neutral tissues. The MediExpand TL Expandable VBR System is intended to be used with supplemental internal spinal fixations systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft material may be used at the surgeon's discretion.
The MediExpand TL Expandable VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The system comprises of vertebral body devices of various heights, sizes and footplates to fit the anatomical needs of a wide variety of patients. The columns can of the device can be adjusted to the exact length required by the patient's anatomy after implantation. Once it is adjusted to the desired length the columns are mechanically locked in place. The devices have a cylindrical space to allow grafting material to be packed inside the devices. Spikes on the footplates improve the anchoring of the implant to the vertebral body. The footplates are available in various lordotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136 and ISO 5832-3.
The provided document is a 510(k) premarket notification for a medical device called the "MediExpand TL Expandable VBR System." This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing specific acceptance criteria and proving performance through a standalone clinical study.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types is not available in this document.
The document primarily details the performance testing done according to ASTM F2077 to demonstrate that the device performs equivalently to the predicate devices, particularly under static and dynamic loading. This type of testing is mechanical, not clinical, and does not involve human readers, expert ground truth, or patient outcome data as would be found in a clinical study for AI performance validation.
Here's an assessment based on the available information:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as pass/fail numerical thresholds for clinical performance in the provided text. The implicit acceptance criterion is "substantial equivalence" to predicate devices, supported by mechanical testing.
- Reported Device Performance: "Static and dynamic testing of the MediExpand TL Expandable VBR System was performed in accordance with ASTM F2077 as recommended by the FDA Guidance for Spinal System 510(k)'s." However, specific numerical results of this testing (e.g., load capacity, fatigue life) are not detailed in this summary.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not applicable as the study described is mechanical testing, not a clinical study involving a test set of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable, as this is mechanical device testing, not a study requiring expert ground truth for interpretation of patient data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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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 physical medical implant, not an AI diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the mechanical testing would be the specified performance requirements of ASTM F2077 and the performance characteristics of the predicate devices. This involves engineering specifications and materials science data, not clinical ground truth.
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The sample size for the training set:
- Not applicable.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.