(37 days)
The Struxxure® 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 disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
Struxxure consists of plates and screws in a variety of sizes. Plates from 1- to 5-levels are offered. Fixed and variable angle screws are available in two diameters in both self-tapping and self-drilling versions.
This 510(k) summary describes a spinal fixation device, not an AI/ML device, and therefore the requested information fields (2-9) about AI/ML studies are not applicable. The device's substantial equivalence is based on mechanical performance testing against predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Measure) | Reported Device Performance (Struxxure® Components) |
|---|---|
| Mechanical Properties | |
| Static Compression Bending (per ASTM F1717) | Meets criteria, demonstrating substantial equivalence to predicate devices. |
| Dynamic Compression Bending (per ASTM F1717) | Meets criteria, demonstrating substantial equivalence to predicate devices. |
| Static Torsion (per ASTM F1717) | Meets criteria, demonstrating substantial equivalence to predicate devices. |
| Technological Characteristics | |
| Basic Design (plate and screw fixation system) | Same as predicates. |
| Material (titanium and titanium alloy) | Same as predicates (titanium Grade 4 or Ti-6Al-4V ELI as per ASTM F67 and ASTM F136). |
| Sizing (diameter and lengths) | Within the range of those offered in the predicate systems. |
| Anatomic Location | Same as predicates. |
| Intended Use | Same as predicates. |
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device. The "test set" in this context refers to the physical samples of the Struxxure® components subjected to mechanical testing. The provenance is the manufacturer (Nexxt Spine).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards (ASTM F1717) and direct measurement of physical properties, not expert consensus.
4. Adjudication method for the test set: Not applicable. Mechanical testing involves direct measurement and comparison to established standards, not adjudication of interpretations.
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: Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used: For the mechanical performance, the ground truth is the measured physical properties (e.g., strength, stiffness, fatigue life) according to the specified ASTM F1717 standard. For the technological characteristics and intended use, the ground truth is the direct comparison to the characteristics of the predicate devices.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
§ 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.