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510(k) Data Aggregation
(22 days)
The NuVasive Halo II Anterior Lumbar Plate System is indicated for use via a 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 Halo II Anterior Lumbar Plate System consists of a series of plates and screws manufactured from Ti-6Al-4V per ASTM F-136 and ISO 5832-3. The plates also include components manufactured from Nitinol alloy SE508 per ASTM F2063.
Here's an analysis of the provided text regarding the NuVasive Halo II Anterior Lumbar Plate System, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Requirements) | Reported Device Performance |
|---|---|
| Material Composition | Manufactured from Ti-6Al-4V per ASTM F-136 and ISO 5832-3. Plates include components manufactured from Nitinol alloy SE508 per ASTM F2063. |
| Design | Substantially equivalent to predicate devices (K072339 NuVasive, Inc. Anterior Lumbar Plate System, K052546 Depuy Spine AEGIS Anterior Lumbar Plate System) in design and technological characteristics. |
| Intended Use | Substantially equivalent to predicate devices in intended use. Indicated for use via lateral or anterolateral surgical approach (T1-L5) or anterior surgical approach (L1-S1) for various spinal instabilities. |
| Mechanical Performance (Strength/Durability) | Meets or exceeds the performance of the predicate device. Demonstrated through nonclinical testing: Static and dynamic compression testing per ASTM F1717, and Static torsion testing per ASTM F1717. |
| Biocompatibility | Implied to be acceptable as materials (Ti-6Al-4V, Nitinol) are standard for implants and the device is deemed "safe and effective." (No specific biocompatibility test results are detailed in the summary). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "nonclinical testing" but does not specify the number of devices or components tested.
- Data Provenance: The studies are "nonclinical testing," meaning they are laboratory-based tests, not human or animal studies. The data is internal to the manufacturer (NuVasive, Inc.). It is retrospective in the sense that the tests were conducted prior to the 510(k) submission, but it's not clinical data.
- Country of Origin: United States (NuVasive, Inc. is based in San Diego, California).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable in the context of this device. The "ground truth" for this type of device (spinal implant) is established through engineering and material standards, and benchmark testing against predicate devices. The "experts" are the engineers and scientists who conducted and interpreted the mechanical and material tests, aligning with established ASTM and ISO standards.
- Qualifications of Experts: Not specified. However, by adhering to ASTM and ISO standards, it's implied that the personnel involved possess the necessary engineering and technical expertise.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. For mechanical performance testing of an implant, there isn't typically an "adjudication" process like there would be for image interpretation. The results are quantitative measurements compared against predefined engineering standards and predicate device performance benchmarks. The determination of whether the device "meets or exceeds" these standards is based on direct measurement and statistical analysis (though the specific statistical methods are not detailed).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No.
- Effect size of human readers with vs. without AI assistance: Not applicable. This device is a physical spinal implant, not an AI-assisted diagnostic or decision-support system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Not applicable. This device is a physical spinal implant, not an algorithm. The "standalone" performance here relates to its mechanical integrity and material properties, which were tested in a standalone manner (without a human implanting it into a patient during the test).
7. Type of Ground Truth Used
- Ground Truth: The ground truth for this device is primarily based on:
- Engineering Standards: Established ASTM (F1717) and ISO (5832-3, F2063) standards for material properties and mechanical performance for spinal implants.
- Predicate Device Performance: The demonstrated performance of legally marketed, substantially equivalent predicate devices (K072339 and K052546). The Halo II system needed to meet or exceed these established benchmarks.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth was Established: Not applicable, as there is no training set for this device.
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