(93 days)
Intervertebral Body Fusion
The NuVasive CoRoent Titanium 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. The CoRoent Titanium System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to 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. The devices are to be used in patients who have had at least six months of non-operative treatment. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
Partial Vertebral Body Replacement
The NuVasive CoRoent Titanium System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
The NuVasive CoRoent Titanium System is a lumbar interbody system manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3. The implants are available in a variety of sizes to suite the individual pathology and anatomical conditions of the patient. 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 NuVasive CoRoent Titanium System is an intervertebral body fusion device and partial vertebral body replacement device. This 510(k) summary indicates that the device met acceptance criteria through Finite Element Analysis (FEA), which demonstrated its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from FEA) | Reported Device Performance (FEA Results) |
|---|---|
| Axial Compression | No new worst-case for performance testing compared to predicate. |
| Compression Shear | No new worst-case for performance testing compared to predicate. |
| Torsion | No new worst-case for performance testing compared to predicate. |
| Subsidence | No new worst-case for performance testing compared to predicate. |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a Finite Element Analysis (FEA).
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of clinical or image-based data. Instead, the performance evaluation was based on Finite Element Analysis (FEA). FEA is a computational method that discretizes a structure into many small elements to analyze its behavior under various loads. The "sample size" for this type of analysis refers to the complexity of the model (e.g., number of elements, nodes) rather than a cohort of patients or images. The document does not provide details on the specific FEA model parameters or the provenance of any physical data used to validate the FEA model, if applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the study described is a Finite Element Analysis (FEA) of the device's mechanical properties, not a study involving human interpretation of medical data where "ground truth" would be established by experts.
4. Adjudication Method for the Test Set:
This information is not applicable as the performance data is derived from Finite Element Analysis (FEA), which is a computational simulation, not a review process requiring human adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The performance data provided is based on Finite Element Analysis (FEA) of the device itself, not a study of human readers' performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The performance study described is a standalone evaluation of the device's mechanical properties through Finite Element Analysis (FEA). This is an "algorithm only" in the sense that it's a computational simulation of the device's behavior, without human intervention in the performance measurement itself (though humans design the FEA and interpret its results).
7. The Type of Ground Truth Used:
The "ground truth" in this context refers to the engineering principles and material properties that govern the behavior of the titanium alloy (Ti-6Al-4V) used in the device. The FEA simulates these physical laws to predict performance. There is no biological or clinical "ground truth" derived from pathology or outcomes data presented for this specific performance evaluation.
8. The Sample Size for the Training Set:
This information is not applicable. Finite Element Analysis (FEA) is a simulation method based on physical laws and material properties, not a machine learning model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" in the context of a Finite Element Analysis (FEA). The "ground truth" for FEA is based on established physics, material science, and engineering standards.
§ 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.