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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 and supplemental internal 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 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 is also indicated for use in the treatment of multilevel degenerative scoliosis in the thoracolumbar spine.

The subject NuVasive Modulus XLIF Interbody System are interbody implants manufactured from 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 and expulsion of the device. The device is intended to be used with supplemental internal 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.

It looks like you've provided a 510(k) Summary for a medical device (NuVasive® Modulus XLIF Interbody System), but this document does not contain any information about acceptance criteria or a study that proves the device meets those criteria, particularly not in the context of an AI/ML-driven medical device.

The document explicitly states: "No clinical studies were conducted." and describes "Non-clinical testing" related to the physical properties of the implant (e.g., static/dynamic compression, shear, gravimetric analysis, etc.). This device is an interbody fusion device, which is a physical implant, not an AI/ML software device.

Therefore, I cannot extract the information you've requested regarding acceptance criteria and a study proving device performance for an AI/ML device from the provided text. The questions you've asked (about sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are highly relevant to AI/ML device validation but are not addressed by this document.

If you can provide a different document that details the validation of an AI/ML medical device, I would be happy to help answer your questions.

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