(129 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 Modulus XLIF 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 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 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(s) manufactured from titanium alloy (Ti-6Al-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 relates to a manufacturing change to the Modulus XLIF interbody implants.
The provided document is a 510(k) premarket notification for the NuVasive Modulus XLIF Interbody System. It describes the device, its intended use, and claims substantial equivalence to previously cleared predicate devices.
However, it explicitly states: "No clinical studies were conducted."
Therefore, the document does not contain information about acceptance criteria or a study that proves the device meets such criteria in terms of clinical performance. The performance data section refers only to non-clinical mechanical testing to demonstrate substantial equivalence to predicate devices, not clinical efficacy or safety.
Here is a breakdown of what can be answered based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify clinical acceptance criteria or report clinical performance data. It only details non-clinical mechanical testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No clinical test set was used as no clinical studies were conducted. The performance data refers to mechanical testing of the implant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. No clinical test set was used, and therefore no ground truth was established by experts in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No clinical test set was used, therefore no adjudication method was applicable.
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
- Cannot be provided. This device is an interbody fusion system, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This device is an implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. As no clinical studies were performed, no ground truth types for clinical performance were established. The "ground truth" for the non-clinical testing would be the predefined mechanical standards (e.g., ASTM F2077) which the device had to meet or exceed.
8. The sample size for the training set
- Cannot be provided. This device is an implant, not a machine learning model, so there is no concept of a training set in this context.
9. How the ground truth for the training set was established
- Cannot be provided. As there is no training set for a machine learning model, this question is not applicable.
In summary, the provided document focuses on the mechanical substantial equivalence of the NuVasive Modulus XLIF Interbody System to predicate devices, rather than clinical performance or acceptance criteria derived from clinical studies.
§ 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.