(76 days)
The Theken VU MESH VBR SYSTEM is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (i.e. fracture).
The Theken VU MESH VBR SYSTEM is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Bone graft material is recommended for packing in the interior opening of the device prior to implantation.
The Theken VU MESH VBR SYSTEM is intended for use with supplemental internal spinal fixation systems, such as the Theken BodyForm Thoracolumbar Fixation System (K983622, Approved 12/98) or the Theken Coral Pedicle Screw System (K041592, Approved 9/04).
The Theken Vu Mesh VBR system is comprised of square footprint polymer cages with fenestrations axially and laterally. It includes toothed endplates, which are used in combination with optional spacer components to extend the range of the cage in smaller increments. The cages, spacers and endplates can be assembled in a variety of combinations to fit each individual patient's pathology. The toothed endplates engage with the superior and inferior endplates of the neighboring vertebral bodies to resist rotation and migration. The Vu Mesh cage may be used individually or in a pair depending on the surgical need, however, the device is always implanted with the mesh cage oriented vertically.
This is a 510(k) summary for a medical device called the "Theken Vu Mesh VBR System," which is a vertebral body replacement device. 510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria for device performance. Therefore, the requested information regarding acceptance criteria, study details, and human reader performance with AI assistance is not available in this document.
This document primarily outlines:
- Device Information: Trade name, common name, classification, materials, and description.
- Intended Use: For thoracolumbar spine (T1-L5) to replace unstable vertebral bodies due to tumor or trauma, to restore biomechanical integrity, and for use with supplemental spinal fixation systems.
- Predicate and Comparative Devices: A list of previously cleared devices to which the Vu Mesh VBR System claims substantial equivalence.
- Substantial Equivalence Argument: The argument is based on similarities in intended use, design, physical characteristics, and material composition to existing devices. Mechanical testing and engineering analysis are mentioned as part of the evidence.
Therefore, I cannot provide the specific details about acceptance criteria and study data as requested because this information is not typically included in a 510(k) summary focused on substantial equivalence.
For completeness, if this were a document that did contain such a study, here's how I would apply your requested framework (displaying what would be absent in this specific document):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Metric) | Threshold/Target | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| (Not available in this 510(k) summary) | (Not available) | (Not available) | (Not available) |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: (Not available in this 510(k) summary)
- Data Provenance: (Not available in this 510(k) summary. Given the nature of a 510(k) for an implant, any testing would likely be bench testing rather than clinical data from human subjects unless specifically required for novel aspects.)
- If clinical data were involved, it would specify: e.g., "Retrospective, multi-center data from 3 US hospitals" or "Prospective, single-center study in Germany."
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: (Not available in this 510(k) summary)
- Qualifications of Experts: (Not available in this 510(k) summary)
- If applicable, this would state: e.g., "3 board-certified orthopedic surgeons with >15 years of experience in spinal surgery."
4. Adjudication Method for Test Set
- Adjudication Method: (Not available in this 510(k) summary)
- If applicable, this would state: e.g., "2+1 consensus: two readers independently reviewed cases, and a third senior reader resolved disagreements."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, this document does not describe an MRMC study.
- Effect size of human readers with AI vs. without AI assistance: Not applicable, as no MRMC study with AI assistance is described.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? No, this document describes a physical medical device (vertebral body replacement system), not an algorithm or AI. Performance is assessed through substantial equivalence to existing devices and mechanical testing.
7. Type of Ground Truth Used
- Type of Ground Truth: (Not applicable as this is a physical device and the 510(k) focuses on substantial equivalence based on design and materials, supported by mechanical testing, rather than an AI/diagnostic algorithm using clinical ground truth.)
- If applicable (e.g., for an AI diagnostic device), this would specify: e.g., "Pathology reports (gold standard)" or "Clinical outcomes data (e.g., patient follow-up over 12 months)."
8. Sample Size for Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.
9. How Ground Truth for Training Set Was Established
- Method for Establishing Ground Truth: Not applicable. This is not an AI/ML device that requires a training set with established ground truth.
§ 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.