(32 days)
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Long Lateral Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the spine: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities, (5) fracture, (6) pseudoarthosis, (7) tumor resection, and/or (8) failed previous fusion.
The NuVasive Long Lateral Spinal System consists of a variety of screws, rods, staples, and caps. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.
The NuVasive Long Lateral Spinal System is a medical device designed for spinal stabilization. The provided documents focus on its substantial equivalence to predicate devices rather than independent performance metrics where "acceptance criteria" and "device performance" would typically refer to clinical accuracy or diagnostic efficacy.
Here's an interpretation of the request based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from 510(k)) | Reported Device Performance (from 510(k)) |
|---|---|
| Substantial equivalence to predicate devices (K091502, K011556, K965145, K993030) in areas including: design, intended use, material composition, function, and range of sizes. | The device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices. |
| Meet or exceed performance of predicate device for mechanical stability. | Results of static and dynamic compression testing (per ASTM F1717) and static torsion testing (per ASTM F1717) show that the subject Long Lateral Spinal System meets or exceeds the performance of the predicate device. |
| Safe and effective for intended use. | Based on performance testing and comparison to predicate devices, the device was found safe and effective for its intended use. |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not applicable in this context. The "test set" here refers to the mechanical testing performed on the device components, not a clinical data set. The documents do not specify the number of units or replicates tested for the mechanical evaluations.
- Data provenance: The data comes from "nonclinical testing" performed by NuVasive, Inc. The exact location or origin of the materials tested is not specified (e.g., country of origin). The testing is inherently prospective for the purpose of demonstrating mechanical equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in this 510(k) context refers to the established standards for mechanical performance (e.g., ASTM F1717) and the performance of the predicate devices. Expert consensus on clinical ground truth is not relevant for this type of submission. The evaluation was conducted by NuVasive's R&D and regulatory teams.
4. Adjudication method for the test set
Not applicable. This device utilizes non-clinical mechanical testing, not a clinical study requiring adjudication of expert interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a spinal implant system, not a diagnostic AI device. Therefore, MRMC studies or AI assistance for human readers are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this 510(k) submission is primarily based on:
- Benchmarking against predicate devices: The performance and characteristics of the legally marketed predicate devices (K091502, K011556, K965145, K993030) serve as the standard for substantial equivalence.
- Industry standards: Adherence to established ASTM International standards (ASTM F1717 for static and dynamic mechanical testing) dictates the methodology and acceptable parameters for evaluating device performance.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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.