(45 days)
The NuVasive Lateral Plate System is indicated for use via the 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 Lateral Plate System consists of a variety of plates, screws, bolts, and Implant components can be rigidly locked to suit the individual locking nuts. pathology and anatomical conditions of the patient.
This document (K061789) is a 510(k) Premarket Notification for the NuVasive Lateral Plate System.
Based on the provided text, a conventional acceptance criteria and study that proves the device meets specific performance metrics, as one might find for software or diagnostic devices, was not conducted and is not present in this document. This document instead follows the regulatory pathway for medical devices seeking substantial equivalence to already legally marketed predicate devices.
Here's an breakdown of why the requested information isn't available and what was done instead:
Explanation of Absence of Requested Information for K061789
The provided document is a 510(k) Premarket Notification, which is a regulatory submission to the FDA. For devices seeking clearance via the 510(k) pathway, the primary goal is to demonstrate "substantial equivalence" to a predicate device already on the market. This typically involves comparing device features, intended use, materials, and technological characteristics, and often includes non-clinical performance testing (e.g., mechanical testing). It generally does not require de-novo clinical studies with acceptance criteria based on performance metrics like sensitivity, specificity, or reader improvement.
Specifically, the document states:
- "H. Summary of Clinical Tests (Not Applicable)." (Page 1) This explicitly indicates that no clinical trials were performed to demonstrate performance in humans for this submission.
- "Data was provided which demonstrated the NuVasive Lateral Plate to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, material, and function." (Page 1) This is the core of a 510(k) submission.
Therefore, the following requested sections cannot be filled from the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable; no such criteria or performance reporting for clinical metrics are present.
- Sample sized used for the test set and the data provenance: Not applicable; no clinical test set was used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no clinical test set requiring expert ground truth was used.
- Adjudication method: Not applicable; no clinical test set requiring adjudication was used.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable; no clinical study was performed.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable; this device is a physical implant, not an algorithm.
- The type of ground truth used: Not applicable; no clinical ground truth was established for performance metrics.
- The sample size for the training set: Not applicable; this device is a physical implant, not an AI/ML algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable; this device is a physical implant, not an AI/ML algorithm requiring a training set.
What Was Done Instead (Based on the Document):
The substantial equivalence was demonstrated through:
- Comparison of Indications for Use: The NuVasive Lateral Plate System has indications for use that are considered equivalent to predicate devices for spinal instability due to various conditions (fracture, tumor, degenerative disc disease, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous surgery) in thoracic, thoracolumbar, lumbar, and lumbosacral regions.
- Design, Material, and Function Equivalence: The document states that "substantial equivalence is based upon equivalence in indications for use, design, material, and function." This implies that the design of the plates, screws, bolts, and locking nuts, the materials used for these components, and how they function (e.g., interlocking mechanisms, stability) were demonstrated to be similar enough to predicate devices.
- Non-Clinical Tests: "Mechanical testing was presented." This is the primary form of 'testing' mentioned for physical implants in a 510(k). This testing would typically assess aspects like fatigue strength, pull-out strength, bending stiffness, and torsional rigidity to ensure the device can withstand physiological loads and perform its intended mechanical function safely, similar to predicate devices. The specific acceptance criteria and results of these mechanical tests are not detailed in this summary document but would have been part of the full 510(k) submission.
In summary, this document is a regulatory clearance letter and summary for a physical medical device. It relies on demonstrating substantial equivalence and mechanical testing, not clinical studies with performance acceptance criteria as typically seen for diagnostics or AI/ML devices.
§ 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.