(85 days)
The NuVasive Modulus TLIF 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 nonoperative treatment.
The NuVasive Modulus TLIF Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended 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 Nu Vasive Modulus TLIF Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
The subject NuVasive Modulus TLIF 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 thoracolumbar spine.
The provided text describes a medical device, the NuVasive Modulus TLIF Interbody System, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study that uses an AI algorithm or human readers to meet specific performance metrics.
The document is a 510(k) summary for premarket notification to the FDA, demonstrating that the device is substantially equivalent to existing, legally marketed predicate devices. This type of submission primarily focuses on comparing the new device's design, intended use, material composition, and function to already approved devices, rather than conducting new clinical trials or extensive performance studies against specific acceptance criteria for AI algorithms.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and the reported device performance: No such criteria or performance against them for an AI algorithm are mentioned. The "Performance Data" section (page 4) refers to non-clinical mechanical testing (e.g., static/dynamic compression, shear, push-out, subsidence) to show equivalence to predicates, not AI performance.
- Sample size used for the test set and the data provenance: Not applicable to an AI study in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No such study is mentioned. The document explicitly states, "No clinical studies were conducted."
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there's no AI algorithm described.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, this document describes the physical characteristics and mechanical performance testing of a spinal interbody fusion device, not an AI-powered diagnostic or therapeutic system.
§ 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.