(90 days)
The NuVasive® ACP System is intended for anterior screw fixation of the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The Nu Vasive Archon Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of the implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion. Additionally, the three-hale version of the implant system may be appropriate only for patients with large vertebral bodies, and is particularly suited for use following corpectomies for the treatment of tumors and burst fractures.
The NuVasive SmartPlate Gradient Plus System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
The NuVasive HELIX Anterior Cervical Plating System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
The NuVasive Anterior Cervical Plate Systems are anterior cervical plating systems that consist of a variety of implant components including screws and plates, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject devices components are from titanium (Ti-6A1-4V) conforming to ASTM F1472/F136 and ISO 5832-3, (titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 or ISO 5832-3, and nickel-cobalt-chromium-molybdenum alloy (MP35N) per ASTM F562.
This document pertains to the 510(k) premarket notification for the NuVasive® Anterior Cervical Plate Systems, identifying them as substantially equivalent to legally marketed predicate devices. The information provided focuses on the regulatory clearance process for a medical device and describes the types of testing conducted to demonstrate safety and substantial equivalence to predicate devices, rather than a study proving an AI/software device meets specific performance criteria against a ground truth.
Therefore, the requested information for an AI/software device's acceptance criteria and study proving performance (e.g., sample size, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth sources) cannot be extracted from this document. This document describes the mechanical, material, and MRI compatibility testing for a physical implant system.
However, I can extract the acceptance criteria and the types of studies conducted for this physical medical device based on the provided text:
Acceptance Criteria and Device Performance (for a physical medical device)
| Acceptance Criteria (What the device must satisfy) | Reported Device Performance (How the device satisfies the criteria) |
|---|---|
| Substantial Equivalence to Predicate Devices: | The NuVasive Anterior Cervical Plate Systems were shown to be substantially equivalent to predicate devices (K071329, K073275, K083341, K093804, K203253, K122910, K131025, K053581) through comparison of design, intended use, material composition, function, and range of sizes. |
| Safety and Compatibility in Magnetic Resonance (MR) Environment: | 1. Magnetically induced displacement force: Tested per ASTM F2052. |
| 2. Magnetically induced torque: Tested per ASTM F2213. | |
| 3. Radiofrequency (RF) induced heating: Tested per ASTM F2182. | |
| 4. MR image artifact: Tested per ASTM F2119. | |
| Tests were conducted as per FDA's guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014 and relevant standards. | |
| Sterile Packaging Validation (for Helix ACP System): | Sterile packaging validations were executed for the Helix ACP System to support the introduction of sterile packaging. |
| Performance Meets or Exceeds Predicate Devices and Introduces No New Risks: | The results of the conducted studies (MRI compatibility and sterile packaging validations) show that the subject NuVasive Anterior Cervical Plate Systems meet or exceed the performance of the predicate devices and do not introduce any new risks. |
Information Not Applicable or Not Found in the Document (for an AI/Software Device Context):
- Sample size used for the test set and the data provenance: Not applicable, as this is a physical medical device. The document mentions an evaluation (e.g., comparing material properties), not a test on a "data set."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant would typically be engineering specifications, material standards, and biomechanical performance metrics, not expert consensus on images.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is not an AI/software device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this specific device, "ground truth" would be established by validated engineering test methods against industry standards (ASTM, ISO), material properties, and potentially biomechanical testing. The document explicitly lists the ASTM standards used for MRI compatibility.
- The sample size for the training set: Not applicable. This is not an AI/software device that undergoes "training."
- How the ground truth for the training set was established: Not applicable.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.