(264 days)
The NuVasive Monolith Cervical Corpectomy System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The NuVasive® Monolith Cervical Corpectomy System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The NuVasive® Monolith Cervical Corpectomy System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The NuVasive Monolith Cervical Corpectomy System is a vertebral body replacement system manufactured from Polyetheretherketone (PEEK) Optima LT-1 conforming to ASTM F2026. The Monolith Cervical 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 standard and railed 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.
The provided text is a 510(k) summary for the NuVasive Monolith Cervical Corpectomy System, a medical device. This document describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria, performance metrics, or the detailed results of a study designed to prove the device meets those criteria in the format typically used for software or AI-driven diagnostic tools.
Instead, the document focuses on demonstrating substantial equivalence for a physical implant device, which is a different regulatory pathway than what would require detailed performance metrics against specific acceptance criteria for, say, an AI algorithm.
However, I can extract the information that is present and indicate where the requested information is not provided for this type of medical device submission.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or a direct comparison table of acceptance criteria versus reported performance for the device in the manner expected for a software or AI product. For a physical implant like the NuVasive Monolith Cervical Corpectomy System, "performance" is generally assessed through mechanical testing and clinical outcomes demonstrating safety and effectiveness comparable to predicate devices.
The document states:
- "Mechanical performance testing data was provided as part of previous submissions to establish substantial equivalence for its use as a vertebral body replacement in the throacolumbar spine: worst case devices included with the subject system were tested and cleared in these predicate 510(k) submissions."
- "Additional dynamic compression and dynamic torsion testing per ASTM F2077 was performed for the subject device."
- "Based on the clinical data, it was determined that the NuVasive Monolith Cervical Corpectomy System used in the treatment of cervical degenerative disorders, tumor, fracture, and osteomyelitis has a safety and effectiveness profile similar to the predicate device."
- "The subject NuVasive Monolith Cervical Corpectomy System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated. The document refers to a "retrospective clinical study on patients." The number of patients is not provided.
- Data Provenance: Retrospective clinical study. The country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable or not provided. For this type of device, "ground truth" would relate to clinical outcomes rather than expert interpretation of medical images. The adjudication method for clinical outcomes isn't detailed in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable or not provided. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on image interpretation in diagnostic AI studies. This document describes a physical implant and its clinical performance.
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
No. This is a physical implant, not an AI or diagnostic software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The phrase "clinical data" and "safety and effectiveness profile similar to the predicate device" strongly suggest that the ground truth was based on outcomes data from the retrospective clinical study.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable.
§ 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.