(30 days)
The NuVasive Modulus-C Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Modulus-C Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral fusion to facilitate fusion.
The subject NuVasive Modulus-C Interbody System is designed to address cervical pathologies utilizing interbody placement through an anterior surgical approach. The NuVasive Modulus-C Interbody System implants are porous, hollow, devices additively manufactured from Grade 23 titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001 Class C. Modulus-C has solid and porous structures which 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 body lattice structure provides additional space for graft packing. The microporous, textured surfaces on the superior and inferior ends of the subject device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Mod-C is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the cervical spine.
The provided FDA 510(k) document for the NuVasive® Modulus-C Interbody System does not contain information related to an AI/ML-based medical device study.
The document describes a medical device (intervertebral body fusion device) and its non-clinical performance testing. It focuses on demonstrating substantial equivalence to predicate devices based on mechanical properties and material composition.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies, as there is no AI/ML component or related study described in the provided text.
The document specifically states: "No clinical studies were conducted." and describes non-clinical testing focused on mechanical performance.
§ 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.