(84 days)
NuVasive® Lumbar Non-Interfixated Interbody Implants:
The NuVasive Lumbar Non-Interbody Implants, including CoRoent System and CoRoent Ti-C System, are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion and supplemental internal spinal fixation system cleared by the FDA for use in the lumbosacral spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Lumbar Non-Interfixated Interbody Implants (L and XL platforms) are intended for use at either one level or two contiguous levels in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
NuVasive® Lumbar Interfixated Interbody Implants:
The NuVasive Lumbar Interfixated Interbody Implants, including CoRoent Single Tab System, CoRoent XL-F System, Brigade Standalone System, and Brigade Hyperlordotic System, are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous 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 Lumbar Interfixated Interbody Implants are intended for two contiguous level or two contiguous levels in the lumbar spine (L2-S1 for Brigade Systems and L2-L5 for CoRoent Single Tab and XL-F) for the treatment of desc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
CoRoent Single Tab System, CoRoent XL-F System, and Brigade Hyperlordotic System are intended to be used with supplemental fixation systems that that are cleared by the FDA for use in the lumbosacral spine.
The subject NuVasive Lumbar Interbody Implants are interbody implants manufactured from PEEK-Optima LT-1 conforming to ASTM F2026. Additinally, CoRoent Ti-C implants are PEEK devices with a commercially pure titanium (CP Ti) coating applied to the superior and inferior surfaces of the device. The PEEK devices contain titanium alloy radiographic markers conforming to ASTM F136 or ASTM F1472 or tantalum markers conforming to ASTM 560 or ISO 13782. The device's hollow core or graft aperture allows for packing of graft material to help promote a solid fusion. Small spikes or teeth on each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device.
The interfixated version of the subject NuVasive Lumbar Interbody Implants devices are composed of an interbody device manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, MP35N conforming to ASTM F562, and titanium alloy conforming to ASTM F136 and ISO 5832-3. The Lumbar Interfixated Interbody System implants have four screw holes in the anterior wall of the PEEK implant that allow titanium alloy screws to be placed in the cranial and caudal vertebral bodies or one or two integrated tabs to allow a titanium alloy screw to be placed in the cranial and caudal vertebral bodies. Additionally, implants include titanium alloy radiographic markers conforming to industry recognized standards.
The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. In addition to the integrated screws, the device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
The document is a 510(k) premarket notification for NuVasive® Lumbar Interbody Implants. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and proving performance through a study with specific outcome metrics. As such, the information requested in your prompt regarding acceptance criteria, study details, and performance metrics is largely not present in the provided text.
Specifically:
- Table of acceptance criteria and reported device performance: This information is not explicitly provided in the document. The document states that the "NuVasive Lumbar Interbody Implants meets the same criteria as the predicate devices," but it does not list these criteria or specific performance metrics.
- Sample size used for the test set and data provenance: No test set in the sense of a clinical trial or a specific dataset for algorithm evaluation is described. The document mentions "clinical literature review" but does not specify a sample size for this review, nor does it detail the provenance of the cases within that literature.
- Number of experts used to establish the ground truth and qualifications: This is not applicable as no ground truth determination by experts for a test set is described.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was done. The document explicitly states: "No clinical studies were conducted."
- Standalone (algorithm only) performance: Not applicable, as this device (interbody implants) does not involve an algorithm.
- Type of ground truth used: Not applicable, as no formal "ground truth" was established for a test set. The substantial equivalence argument relies on mechanical testing data from previous submissions for predicate devices and a clinical literature review.
- Sample size for the training set: Not applicable, as this device does not involve machine learning or a training set.
- How the ground truth for the training set was established: Not applicable.
The document's "Performance Data" section (G) explains:
- Mechanical performance: This was "provided as part of the previous submissions to establish substantial equivalence for their use in the lumbosacral spine." It states that "worst case devices included with the subject system were tested and cleared in these predicate 510(k) submissions." No new mechanical testing was performed for this specific 510(k) submission.
- Clinical literature review: This was "performed to support the use of the subject device with allogeneic bone graft for interbody fusions of the lumbar spine." The conclusion was that the device "has a safety and effectiveness profile that is similar to the predicate devices."
In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence for an orthopedic implant based on comparison to predicate devices and existing mechanical testing data, rather than a study report detailing specific acceptance criteria and performance metrics of a new device evaluated through a test set and ground truth.
§ 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.