(153 days)
The NuVasive Decade Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
The NuVasive Decade Lateral Plate System is an anterior/anterolateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The Decade Lateral Plate System includes plates, large bolts, threaded small bolts, and impactable small bolts manufactured from titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 or ISO 5832-3, 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 of this 510(k) premarket notification is for the addition of the impactable small bolt.
The provided text describes a medical device, the NuVasive® Decade Lateral Plate System, which is a spinal implant. The document is a 510(k) summary from NuVasive, Inc. to the FDA, demonstrating substantial equivalence to predicate devices.
This document describes a spinal implant (hardware) device, not an AI/Software as a Medical Device (SaMD). Therefore, the requested information pertaining to AI/SaMD (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set, etc.) is not applicable and not available in this filing.
The "Performance Data" section (G) in the document outlines non-clinical testing performed to demonstrate substantial equivalence to predicate devices.
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria with corresponding performance values for the NuVasive Decade Lateral Plate System. Instead, it states that "The results demonstrate that the subject Decade Lateral Plate System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate devices."
The acceptance criteria are implicitly defined by the standards and the performance of the predicate devices. The "reported device performance" is the successful demonstration of equivalence through the listed non-clinical tests.
| Performance Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Static Compression (per ASTM F1717) | Equivalent or superior to predicate device | No new worst-case for performance testing; Substantially equivalent to predicate devices |
| Dynamic Compression (per ASTM F1717) | Equivalent or superior to predicate device | No new worst-case for performance testing; Substantially equivalent to predicate devices |
| Static Torsion (per ASTM F1717) | Equivalent or superior to predicate device | No new worst-case for performance testing; Substantially equivalent to predicate devices |
| Cadaveric Dynamic Torsional Physiological Testing with micro-CT analysis | Equivalent or superior to predicate device | No new worst-case for performance testing; Substantially equivalent to predicate devices |
| Static Tension (per ASTM F1717) | Equivalent or superior to predicate device | No new worst-case for performance testing; Substantially equivalent to predicate devices |
| Static Separation Testing | Equivalent or superior to predicate device | No new worst-case for performance testing; Substantially equivalent to predicate devices |
| Nominal and Angled Screw Push-out Testing | Equivalent or superior to predicate device | No new worst-case for performance testing; Substantially equivalent to predicate devices |
| CAD Dimensional Analysis | Conformance to design specifications and equivalence to predicate devices | No new worst-case for performance testing; Substantially equivalent to predicate devices |
2. Sample size used for the test set and the data provenance:
Not applicable. This is not an AI/SaMD study, but rather non-clinical physical testing of a medical implant. The "test set" would refer to the number of physical samples of the device components (plates, bolts, etc.) subjected to mechanical testing. This detail is not provided in the summary.
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 AI/SaMD is not relevant for this physical device testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically for expert consensus in clinical or image-based studies, not for physical device testing.
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-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for this device's performance is based on the established safety and effectiveness of its predicate devices and its ability to meet the relevant ASTM F1717 physical testing standards.
8. The sample size for the training set:
Not applicable. This is a physical device, not an AI/Machine Learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set is used for this physical 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.