(62 days)
The NuVasive® Monolith 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 Monolith 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 material may be used at the surgeon's discretion.
The Monolith Corpectomy System is a vertebral body replacement system manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. The Monolith 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 Monolith Corpectomy System is provided non-sterile to be sterilized by the user before each use.
I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study proving the device meets them in the format requested.
The document is a 510(k) Premarket Notification for the NuVasive® Monolith Corpectomy System. It primarily focuses on demonstrating substantial equivalence to already marketed predicate devices.
Here's what the document does say regarding performance:
- Performance Data: Nonclinical testing was performed to demonstrate substantial equivalence. The following tests were mentioned:
- Static Axial compression and torsion per ASTM F2077
- Push-out Analysis
- Subsidence Analysis
- MR Compatibility Analysis
- Additional Analysis: Finite Elemental Analysis (FEA) and engineering rationale were provided.
- Conclusion: The results of the testing and FEA demonstrate that the subject Monolith Corpectomy System is substantially equivalent to predicate devices.
- Crucially: "No non-clinical or clinical studies were conducted."
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance (specific numerical acceptance criteria are not detailed, nor are the specific numerical results of the tests).
- Sample size for the test set or data provenance (as no clinical studies were performed).
- Number of experts or their qualifications, or adjudication method (as no studies requiring expert review were performed).
- Information on MRMC or standalone studies (as no clinical studies were performed).
- Type of ground truth used (not applicable here, as it's a mechanical device tested against engineering standards, not diagnostic performance).
- Sample size for the training set or how ground truth was established for it (not applicable here, as this is not an AI/machine learning device).
The document is about demonstrating the mechanical and material equivalence of a medical implant to existing devices through engineering tests, not about the performance characteristics of an AI or diagnostic device that would typically involve the criteria you've asked for.
§ 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.