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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 Modulus XLIF internal fixation, the system is intended 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 thoracy disc herniation (with myelopathy and/or radiculopathy 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 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-6Al-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 to provide additional migration resistance and stability. When used with or without the internal fixation plate and bone screw, 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 provide an optional internal fixation plate with bone screw.

This document is about the NuVasive Modulus XLIF Interbody System, an intervertebral body fusion device.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" for the device, but rather refers to demonstrating substantial equivalence to predicate devices. The performance data presented focuses on mechanical testing to ensure the device meets the same standards as previously cleared devices.

2. Sample Size Used for the Test Set and Data Provenance

This submission describes non-clinical testing and analysis on the device itself, not a clinical study involving human or animal subjects. Therefore, the concepts of "test set" and "data provenance" in the context of clinical data do not directly apply. The sample size for the mechanical tests would be the number of physical device units tested, but this detail is not provided in the summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device underwent mechanical testing, not a study requiring expert readers to establish ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable, as no expert adjudication of a clinical test set was performed.

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 an implantable medical device, not an AI or imaging diagnostic tool, so an MRMC study is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this device does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established engineering standards and comparisons to predicate devices. Specifically, the device's mechanical properties (compression, torsion, screw push-out) were evaluated against the performance of predicate devices, which are already deemed safe and effective based on their established regulatory history and testing.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning algorithms that require a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

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