(151 days)
The NuVasive® Mesh is a 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 NuVasive® Mesh 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 NuVasive® Mesh is an implantable titanium vertebral body replacement device indicated for use in the thoracic and lumbar spine (i.e., T1 to L.5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
A plurality of rhombic pattern holes are built in the wall, transverse to the longitudinal axis. The hollow core allows for packing of bone grafting materials to help promote a solid fusion. A ring of small spikes or teeth on each end of the device serves to grip the endplates of the adjacent vertebrae to resist expulsion.
The device is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
The provided text describes a 510(k) submission for the NuVasive® Mesh Vertebral Body Replacement Device. This device is an implantable surgical device, not an AI/ML powered medical device. Therefore, much of the requested information (such as acceptance criteria for AI algorithms, sample sizes for training/test sets, expert adjudication methods, MRMC studies, and ground truth establishment for AI) is not applicable or present in this document.
However, based on the information provided, here's what can be extracted and inferred regarding the device's acceptance and validation:
Acceptance Criteria and Device Performance
The core "acceptance criteria" for a 510(k) submission for a non-AI medical device like this is substantial equivalence to legally marketed predicate devices. The "performance" is demonstrated through comparative analysis and mechanical testing, rather than an AI algorithm's metrics.
| Acceptance Criteria Category | Reported Device Performance (as demonstrated for Substantial Equivalence) |
|---|---|
| Design | Substantially equivalent, if not identical, to predicate devices. |
| Materials of Composition | Substantially equivalent, if not identical, to predicate devices. |
| Indications for Use | Substantially equivalent to predicate devices. |
| Mechanical Properties | Demonstrated through mechanical testing to be substantially equivalent to predicate devices. |
| Safety and Effectiveness | Implied through substantial equivalence to legally marketed predicate devices. |
Study Information
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Sample size used for the test set and the data provenance:
- Not Applicable. This is a hardware implant. The "test set" in this context would refer to the mechanical tests performed on multiple units of the device to ensure consistency and meet engineering specifications. The document states "Mechanical testing was presented," but does not detail the number of units tested or their provenance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth in the context of AI/ML is not relevant here. The "ground truth" for a mechanical device is its physical and material properties and its performance under load, validated through engineering standards and testing. Expert input would come from engineers, material scientists, and potentially surgeons reviewing the design and testing protocols. No specific number or qualifications are mentioned for this type of review in the provided text.
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Adjudication method for the test set:
- Not Applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in human expert labeling for AI ground truth. For mechanical testing, the "adjudication" is based on comparing test results against predefined engineering specifications and predicate device data.
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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 physical implant, not an AI system. MRMC studies are used for evaluating diagnostic systems, typically AI-powered, where human readers interpret medical images.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a physical device, the "ground truth" is established through engineering specifications, material science principles, and preclinical bench testing (e.g., fatigue testing, compression strength, pull-out strength). The document mentions "Mechanical testing was presented." The ultimate "ground truth" for its safety and effectiveness for its intended use is demonstrated by its substantial equivalence to predicate devices that have a history of safe and effective use.
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The sample size for the training set:
- Not Applicable. Training sets are for AI algorithms. For a mechanical device, manufacturing processes involve quality control and statistical process control, but there isn't a "training set" in the AI sense.
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How the ground truth for the training set was established:
- Not Applicable. As above, this concept doesn't apply to this type of device.
Summary of the "Study" (Demonstration of Substantial Equivalence)
The "study" or validation presented is a 510(k) submission focusing on demonstrating substantial equivalence to previously cleared predicate devices.
- Evidence presented: Engineering drawings, labeling, and mechanical testing.
- Comparison points: Design, materials of composition, and indications for use.
- Conclusion: The device was deemed "substantially equivalent, if not identical, to its predicate devices."
- Clinical Tests: Explicitly stated as "Not Applicable" (H. Summary of Clinical Tests). This indicates that no human clinical trials were conducted or required for this 510(k) clearance, as substantial equivalence was demonstrated through non-clinical means.
In essence, the "study" is a comprehensive regulatory comparison and non-clinical engineering validation rather than a clinical or AI performance study.
§ 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.