(125 days)
The Nuvasive® PEEK Corpectomy System is a partial or total vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The PEEK Corpectomy System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft may be used at the surgeon's discretion.
The NuVasive PEEK Corpectomy System is a vertebral body replacement system manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. The PEEK Corpectomy System is made up of two primary components: a core and a set of endcaps. The core is offered in a variety of shapes and sizes to suit individual pathology and anatomical conditions of the patient. The modular endcaps are offered in multiple footprints and lordosis options. The device contains pins made of either titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3 or tantalum conforming to ASTM F560 or ISO 13782 to serve as radiopaque markers. The System is provided non-sterile, and is designed to be sterilized by the user before each use.
This document is a 510(k) summary for the NuVasive PEEK Corpectomy System, a device for spinal vertebral body replacement. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than providing detailed acceptance criteria and a study design for a diagnostic or AI device. Therefore, much of the requested information regarding acceptance criteria, study sample sizes (test and training sets), expert involvement for ground truth, adjudication methods, and MRMC studies is not applicable or available in this document.
Here's an analysis based on the provided text, highlighting what is (and isn't) present:
Key Takeaway: This submission relies on non-clinical mechanical testing to demonstrate substantial equivalence, not clinical performance data for a diagnostic device. As such, many of the requested elements related to diagnostic accuracy (like sensitivity, specificity, expert ground truth, etc.) are not applicable here.
Description of Acceptance Criteria and Proving Device Meets Them
This document does not describe acceptance criteria in the context of clinical performance or diagnostic accuracy (e.g., sensitivity, specificity, or agreement with ground truth established by experts). Instead, it demonstrates the device meets mechanical performance standards to show substantial equivalence to legally marketed predicate devices.
The "acceptance criteria" are implicitly the successful completion of the specified non-clinical tests, with results comparable to or better than predicate devices, thereby ensuring the device is safe and effective for its intended mechanical function within the body.
The study that proves the device meets these (mechanical) criteria is the set of non-clinical tests performed.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a mechanical device, not a diagnostic one, typical "acceptance criteria" like sensitivity/specificity are not applicable. The implicit acceptance criteria are successful completion of the following non-clinical tests and demonstrating comparable performance to predicate devices. The document does not provide specific numerical criteria or performance values from these tests, but states that the results "demonstrate that the subject PEEK Corpectomy System is substantially equivalent to predicate devices."
| Acceptance Criteria (Implicit from Testing) | Reported Device Performance (Implicit from Study Conclusion) |
|---|---|
| Withstand static and dynamic axial compression per ASTM F2077 | "The results demonstrate that the subject PEEK Corpectomy System is substantially equivalent to predicate devices." (Implies successful completion within acceptable limits) |
| Withstand static and dynamic torsion per ASTM F2077 | "The results demonstrate that the subject PEEK Corpectomy System is substantially equivalent to predicate devices." (Implies successful completion within acceptable limits) |
| Maintain stability during push-out testing | "The results demonstrate that the subject PEEK Corpectomy System is substantially equivalent to predicate devices." (Implies successful completion within acceptable limits) |
| Exhibit acceptable subsidence characteristics based on analysis | "The results demonstrate that the subject PEEK Corpectomy System is substantially equivalent to predicate devices." (Implies successful completion within acceptable limits) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the document. For mechanical testing, this refers to the number of devices or constructs tested for each mechanical analysis (e.g., how many devices were subjected to axial compression). This information is typically found in the full test reports, not usually in the 510(k) summary.
- Data Provenance: Not applicable in the context of human data. The "data" comes from in vitro mechanical testing performed on the device itself.
- Retrospective or Prospective: Not applicable, as this refers to human data collection. Mechanical testing is a controlled experimental process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth, in the context of expert review, refers to clinical or diagnostic accuracy. This document describes mechanical testing of a medical implant, where "ground truth" is determined by physical measurements and engineering standards, not expert clinical assessment.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication is relevant for expert disagreement in diagnostic or clinical assessment. For mechanical testing, results are quantitative and objective.
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 a medical implant, not an AI or diagnostic imaging device. No MRMC studies were performed. The document explicitly states: "No clinical studies were conducted."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical implant, not an algorithm or software. No standalone performance testing in this context was done.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by engineering standards and mechanical test results. Specifically, the performance of the device relative to established ASTM (American Society for Testing and Materials) standards (F2077) and in comparison to predicate devices, is used to confirm its safety and effectiveness.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device. There is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there's no training set for an AI model, there's no ground truth established for it.
§ 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.