(263 days)
The NuVasive CoRoent Lumbar 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 that are cleared by the FDA for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the devices are to be used in patients who have had at least six months of non-operative treatment.
The CoRoent Lumbar System (L and XL platforms) 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 NuVasive® CoRoent System is manufactured from PEEK-OPTIMA® Optima LT1 (Polyether-ether-ketone) conforming to ASTM standard F2026, Ti-6Al-4V ELI conforming to ASTM standard F136/1472 or Tantalum conforming to ASTM standard F560 or ISO 13782. These implants are available in a variety of shapes and configurations for PLIF/TLIF, XLIF and ALIF approaches, with heights ranging from 6 - 24 mm, widths ranging from 9 - 42 mm, lengths ranging from 20-65 mm and lordotic angles ranging from 0° - 20°, to suit the individual pathology and anatomical conditions of the patient. The hollow aperture allows for packing of autogenous bone graft. Teeth on the superior and inferior surface of the implants provide resistance to expulsion.
Both the subject device and its accessory surgical instruments are packaged as non-sterile, to be sterilized by the end user. In addition, the implants are also offered in sterile packaged versions.
Here's a breakdown of the acceptance criteria and study information for the NuVasive® CoRoent® System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate devices) | Reported Device Performance (NuVasive® CoRoent® System) |
|---|---|
| Static axial compression strength | Met the same criteria as predicate devices |
| Dynamic axial compression strength | Met the same criteria as predicate devices |
| Static compression shear strength | Met the same criteria as predicate devices |
| Dynamic compression shear strength | Met the same criteria as predicate devices |
| Resistance to subsidence | Met the same criteria as predicate devices |
| Mechanical integrity under various loads | Met the same criteria as predicate devices |
2. Sample Size and Data Provenance
This information is not applicable as no human clinical data was used for this 510(k) submission. The performance data was based on nonclinical testing.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
This information is not applicable as ground truth related to human observation or clinical outcomes was not established for a test set in this submission. The "ground truth" for nonclinical testing would be the ASTM standards themselves and the inherent properties of the materials and design compared to predicate devices.
4. Adjudication Method (Test Set)
This information is not applicable as there was no human-reviewed test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case comparative effectiveness study was not done. The submission explicitly states, "No clinical studies were conducted."
6. Standalone (Algorithm Only) Performance Study
This information is not applicable as this is a medical device (intervertebral body fusion system) composed of physical materials, not an algorithm or software requiring standalone performance evaluation.
7. Type of Ground Truth Used
The ground truth used for demonstration of substantial equivalence was based on:
- ASTM Standards: F2077 (for static and dynamic axial compression and compression shear) and F2267 (for subsidence testing). These established engineering standards serve as the "ground truth" for mechanical performance of intervertebral body fusion devices.
- Predicate Device Performance: The "ground truth" was also implicitly derived from the established performance of legally marketed predicate devices. The NuVasive CoRoent System aimed to meet the same criteria as these already cleared devices.
8. Sample Size for the Training Set
This information is not applicable as there was no training set in the context of an algorithm or machine learning. The "training" in this context would be the design and engineering process to ensure the device met the specified ASTM standards and matched the characteristics of predicate devices.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there was no training set in the context of an algorithm or machine learning. The design and manufacturing process for the device was informed by material science, biomechanical engineering principles, and the performance characteristics of previously cleared predicate devices and established ASTM 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.