(93 days)
The Nu Vasive® 3DP Interfixated ALIF System is indicated for spinal fusion procedures in skeletally mature patients. The 3DP Interfixated ALIF System 10° 20° lordotic cages may be used as a standalone system. The 3DP Interfixated ALIF System 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Nu Vasive 3DP Interfixated ALIF System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectorny in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The 3DP Interfixated ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the 3DP Interfixated ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
The subject NuVasive 3DP Interfixated System are interbody implants manufactured from titanium alloy (Ti-6A1-4V 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. The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The 3DP Interfixated ALIF System 10°-20° lordotic cages may be used as a standalone system. The 3DP Interfixated ALIF System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.
This document describes the NuVasive® 3DP Interfixated ALIF System, an intervertebral body fusion device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that the device was tested to demonstrate substantial equivalence to predicate devices. The acceptance criteria are implicitly that the device performs comparably to or better than the predicate devices in the specified mechanical tests, and meets relevant ASTM and ANSI/AAMI standards. The "Reported Device Performance" is that the device "meets the same criteria as the predicate devices."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Static Compression (per ASTM F2077) | Meets criteria of predicate devices |
| Dynamic Compression (per ASTM F2077) | Meets criteria of predicate devices |
| Static Compression Shear (per ASTM F2077) | Meets criteria of predicate devices |
| Dynamic Compression Shear (per ASTM F2077) | Meets criteria of predicate devices |
| Static Torsion (per ASTM F2077) | Meets criteria of predicate devices |
| Dynamic Torsion (per ASTM F2077) | Meets criteria of predicate devices |
| Gravimetric and Particulate analysis (ASTM F1714 and F1877) | Meets criteria of predicate devices |
| Subsidence and screw push-out analysis | Meets criteria of predicate devices |
| Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016 | Meets criteria of predicate devices |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes (number of devices tested) for each physical performance test. It only lists the types of tests performed. The data provenance is from nonclinical testing performed by the manufacturer, NuVasive, Incorporated. The nature of these tests (mechanical and material property tests) implies the data is prospective for the specific device being evaluated. No information on country of origin of the data is provided beyond the manufacturer being based in San Diego, California.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device is a medical implant, and the approval is based on physical and mechanical performance testing, not on the interpretation of medical images or clinical data by experts to establish a "ground truth" in the way it would be for an AI/diagnostic device. The ground truth for such a device is established by adherence to engineering standards and comparison to well-established predicate devices.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the evaluation is based on objective measurements from engineering tests against established standards and comparisons to predicate devices, not on subjective expert review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is a key component. This device is an implant, and its effectiveness is determined through mechanical testing and clinical outcomes (which are not part of this 510(k) summary directly, but are implied by the safety and performance).
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical implant, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used:
The ground truth for this device's performance is established by:
- Adherence to recognized consensus standards (e.g., ASTM F2077, ASTM F1714, ASTM F1877, ANSI/AAMI ST72:2011/(R)2016) for intervertebral body fusion devices.
- Comparison to predicate devices with a history of safe and effective use. The "ground truth" is that if the new device performs equivalently or better than these established predicates under defined test conditions, it is considered safe and effective for its intended use.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
§ 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.