(100 days)
The NuVasive® Interfixated Interbody System is indicated for the following:
CoRoent XL-F System
The NuVasive CoRoent XL-F System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle or facet screws) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The devices are to be used in patients who have had at least six months of non-operative treatment.
The CoRoent XL-F System is intended for use in interbody fusions in the lumbar spine from L2 to L5, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) with up to Grade I 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 CoRoent XL-F System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
Brigade System
The Brigade System is indicated for spinal fusion procedures in skeletally mature patients. The Brigade Standalone System (lordotic angles of 8° and 12°) is a standalone system. The Brigade Hyperlordotic System (lordotic angels of 15° to 30°) must be used with supplemental internal spinal fixation systems (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous 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 Brigade 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) with up to Grade I 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 Brigade System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis, and when used in these patients at multiple levels, the Brigade Standalone 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 Interfixated Interbody System are interbodies manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 PEEK-Optima® LT-1, with radiographic markers manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The devices all contain integrated screws made of titanium alloy, and include a hollow core or graft aperture which allows for packing of autograft to help promote a solid fusion. The subject implants contain small spikes or teeth on each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion.
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 CoRoent XL-F System and Brigade Hyperlordotic System devices are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
This document describes a 510(k) submission for the NuVasive® Interfixated Interbody System. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, not primarily to prove performance against specific acceptance criteria through a study with a dedicated test set and ground truth.
Therefore, many of the requested elements (acceptance criteria, device performance table, sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance, training set details) are not explicitly present in this document because the core of a 510(k) for this type of device often focuses on demonstrating equivalence to existing, already-approved devices rather than de novo performance studies with new acceptance criteria.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
- This document does not provide a table of acceptance criteria or reported device performance metrics in the way one would expect for a performance study. The 510(k) application focuses on demonstrating substantial equivalence to predicate devices, implying that the subject device's performance is assumed to be comparable to these already-cleared devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states: "A retrospective clinical analysis was performed to support the use of the subject device as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis."
- Sample Size: Not specified.
- Data Provenance: Retrospective clinical analysis. Country of origin is not specified.
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)
- Not specified, as the primary means of demonstrating equivalence did not involve a study requiring expert-established ground truth for a test set in the traditional sense. The retrospective clinical analysis mentioned does not detail the method of ground truth establishment or expert involvement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- No, an MRMC comparative effectiveness study was not done. This device is an interbody fusion system (implantable medical device), not an AI-driven diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study was not done, as this is an implantable medical device and does not involve an algorithm separate from human intervention for its primary function. The document explicitly states: "This device does not contain software or electrical equipment."
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the "retrospective clinical analysis" mentioned, the ground truth would inherently be based on clinical outcomes data related to fusion efficacy and patient condition in patients with multilevel degenerative scoliosis, as assessed via standard clinical and radiographic follow-up methods post-surgery. However, the specific methodology or explicit "ground truth" definition for this analysis is not detailed in this document.
8. The sample size for the training set
- Not applicable as this is not an AI/algorithm-driven device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI/algorithm-driven device requiring a training set.
Summary of what is present:
- The document is a 510(k) clearance letter and summary for an interbody fusion device.
- The primary method of demonstrating suitability for market was substantial equivalence to existing predicate devices (NuVasive CoRoent XL-F System, CoRoent Single Tab System, CoRoent XLR Standalone System, Brigade Hyperlordotic System, and CoRoent Thoracolumbar System).
- No new performance testing was conducted for the current submission because "No new device designs for the CoRoent XL-F System and no new worst case sizes for the Brigade System are being introduced."
- A retrospective clinical analysis was performed to support the use of the device for multilevel degenerative scoliosis, but details regarding sample size, specific outcomes measured, or how "ground truth" was established within that analysis are not provided in this regulatory document.
- The device is an implantable system made of PEEK-Optima and titanium alloy, with integrated screws. It does not contain software or electrical equipment.
§ 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.