(138 days)
The Modulift VBR System is indicated for use in the cervical soine (C3-C7 vertebral bodies for the small VBR implant) and thoracolumbar spine (T1-L5 vertebral bodies for the small/medium/large VBR implant) in skeletally mature patients for partial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The Modulift VBR System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The Modulift VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, 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 Modulift VBR System is intended to be used with supplemental fixation systems that have been cleared by the FDA. When used in the thoracolumbar spine, the Modulift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. When used in the Cervical Spine at one or two levels, the Modulift Vertebral Body Replacement (VBR) System is intended to be used with supplemental fixation systems (i.e., ABC Anterior Cervical System or the Quintex Cervical System). When used at more than two levels in the cervical spine, supplemental fixation should include posterior fixation that has been cleared by FDA (i.e., Aesculap S4 Cervical System).
The Modulift VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the system is comprised of spacers and foot plates of various heights and sizes to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. Once it is adjusted to the desired height the column is mechanically locked in place by means of locking screws (grub screws). Each spacer has an axial hole to allow grafting material to be packed inside the device. Spikes on the end of the foot plates improve the anchoring of the implant to the vertebral body. The foot plates of the device are available in various lordotic and kyphotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136, and cobalt chrome (CoCr) per ASTM F1537
The purpose of the subject 510(k) is to expand the indications to include use in the cervical spine (C3-C7) of the small VBR devices.
The provided text is a 510(k) summary for the Modulift Vertebral Body Replacement (VBR) System, focusing on expanding its indications to include the cervical spine. This document primarily addresses regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study description with specific acceptance criteria and performance metrics for an AI/device.
Therefore, many of the requested categories for a study demonstrating acceptance criteria and performance cannot be directly filled from this document. The device in question is a physical implant, not an AI or digital health device with typical software-based performance metrics.
Here's an attempt to extract relevant information or state why it's not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (typically mechanical/biocompatibility) | Reported Device Performance (from summary) |
|---|---|
| Mechanical Testing: Implicitly met for substantial equivalence. No specific numerical criteria or results are provided in this summary. | "Mechanical testing" was performed (mentioned in conclusion) but no specific results are detailed. The device is similar in design, material, and indicated use to predicate devices. |
| Material Biocompatibility: Implicitly met as components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136, and cobalt chrome (CoCr) per ASTM F1537, which are standard biocompatible materials. | Materials comply with ASTM standards. |
| Clinical Equivalence/Safety and Effectiveness for Cervical Spine Use: Demonstrated through clinical literature review and a retrospective study. | "The clinical literature suggests that there is a positive benefit associated with use of VBR in the cervical spine with minimal risk." |
2. Sample size used for the test set and the data provenance
The document mentions "A comprehensive clinical literature review and retrospective study has been conducted".
- Sample Size (Test Set): Not explicitly stated. The "test set" here refers to the patient population included in the retrospective study and clinical literature review. The exact number of patients or cases from these sources is not provided.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective):
- Study Type: Retrospective study and clinical literature review.
- Country of Origin: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For a medical device like a VBR system, "ground truth" would typically relate to clinical outcomes and safety, which are usually assessed by treating physicians and follow-up clinical observations, rather than a panel of experts specifically establishing a 'ground truth' score for a diagnostic output.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not provided. Adjudication methods are typically used when multiple readers assess data (e.g., medical images) and their interpretations need to be reconciled. This document describes a physical implant and its clinical claims based on literature and retrospective data, not an AI diagnostic tool requiring multi-reader assessment.
5. 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 vertebral body replacement system, not an AI-assisted diagnostic or treatment planning tool that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the retrospective study and clinical literature review, the "ground truth" would implicitly be:
- Outcomes Data: Clinical outcomes related to the safety and efficacy of VBR devices in the cervical spine (e.g., stability, fusion rates, complications, neurological outcomes).
- Literature Consensus: The overall findings and conclusions from published clinical studies on VBR use in the cervical spine.
8. The sample size for the training set
Not applicable/Not provided. The device itself is not an AI algorithm that undergoes a "training" process. The "retrospective study" and "clinical literature review" serve to provide evidence for the clinical safety and effectiveness of the device in its expanded indication.
9. How the ground truth for the training set was established
Not applicable. As noted above, this device is a physical implant and does not involve a training set for an AI algorithm.
§ 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.