(18 days)
The NuVasive Modulus XLIF Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. When used with or without the internal fixation, the system is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The NuVasive Modulus XLIF Interbody System is intended for use in interbody fusions in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and for use in the lumbar spine from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive Modulus XLIF Interbody System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
The subject NuVasive Modulus XLIF Interbody System are interbody implants manufactured from titanium alloy (Ti-6A1-4V ELI) powder conforming to ASTM F3001. The solid and porous structures are simultaneously built using a powder bed fusion method. The hollow core, or graft aperture, allows for packing of graft to aid in the promotion of a solid fusion. Similarly, the macroporous internal lattice structure provides additional space for graft packing. The microporous, textured surface on the superior and inferior ends of the device serves to grip the adjacent vertebrae to resist migration of the device. An optional internal fixation plate with bone screw manufactured from titanium alloy (Ti-6AI-4V ELI) conforming ASTM F136 or ISO 5832-3 and MP35N conforming to ASTM F562 may be affixed to the adjacent vertebral body or bodies to provide additional migration resistance and stability. When used with or without the internal fixation plate and bone screws, the device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the thoracolumbar spine.
The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
The purpose of this submission is to introduce an optional dual sided fixation modular plate with bone screws.
This document describes the NuVasive® Modulus® XLIF Interbody System, a medical device for intervertebral body fusion. Based on the provided text, here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing (per ASTM F2077) for Dual-Sided Internal Fixation: | Met Criteria: The device was found to meet the same criteria as the predicate devices. |
| - Dynamic axial compression testing | - Performed |
| - Dynamic torsion testing | - Performed |
| - Screw push-out analysis | - Performed |
| Substantial Equivalence (to Predicate Devices): | Achieved Substantial Equivalence: The subject device was shown to be substantially equivalent to its predicate devices through comparison in design, intended use, material composition, and function. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not applicable. The study primarily involved engineering analysis and mechanical testing, not a test set of patient data.
- Data Provenance: Not applicable. The analysis was based on engineering principles and in-vitro mechanical testing, not patient data from a specific country or collected retrospectively/prospectively.
3. Number of Experts and Qualifications
- Number of Experts: Not applicable. This was an engineering and mechanical performance study, not a study requiring expert clinical assessment for ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method
- Adjudication Method: Not applicable. This was not a study involving human assessment or interpretation that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. The text explicitly states, "No clinical studies were conducted." The submission focused on engineering analysis and mechanical performance comparison to predicate devices.
- Effect Size of Human Readers Improvement: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study Done: Not applicable. This device is a physical intervertebral body fusion system, not an algorithm or software. It does not have a "standalone" or "human-in-the-loop" performance in the context of an AI device.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device's performance was established through engineering analysis and adherence to established ASTM standards (specifically ASTM F2077) for mechanical properties. The primary ground truth was comparison to predicate devices deemed safe and effective based on their established performance.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a physical implant, not an AI or machine learning model that requires a training set.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there was no training set for an AI/ML model.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.