(24 days)
The NuVasive Brigade Anterior 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 (TI-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L) I-Sl) 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 Brigade Anterior Plate System is an anterior/anterolateral, thoracolumbar system that consists of a variety of implant components including screws and plates, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3, and Nitinol SE508 alloy conforming to ASTM F2063.
The provided document describes a 510(k) summary for the NuVasive® Brigade® Anterior Plate System, a spinal implant. The focus of the summary is to demonstrate substantial equivalence to previously cleared predicate devices through performance testing. This type of regulatory submission for a medical device does not involve a study to "prove the device meets acceptance criteria" in the way one would for an AI/CADe device.
Instead, the "acceptance criteria" here refer to demonstrating that the new device performs at least as well as, or better than, the predicate devices in specific mechanical tests, thereby proving substantial equivalence. There is no AI component, and thus no need for human expert review, ground truth establishment, or MRMC studies.
Here's an analysis based on the provided text, adapted to the questions where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
Note: For a mechanical device like a spinal implant, "acceptance criteria" are typically defined by recognized standards (e.g., ASTM) and internal design specifications. The performance is measured against these standards or compared directly to predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Static Compression per ASTM F1717 | The subject Brigade Anterior Plate System meets or exceeds the performance of the predicate device. |
| Dynamic Compression per ASTM F1717 | The subject Brigade Anterior Plate System meets or exceeds the performance of the predicate device. |
| Static Torsion per ASTM F1717 | The subject Brigade Anterior Plate System meets or exceeds the performance of the predicate device. |
| Material Composition Conformance | Manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3, and Nitinol SE508 alloy conforming to ASTM F2063. |
| Intended Use Equivalence | Substantially equivalent to predicate devices for the stated indications. |
| Technological Characteristics Equivalence | Substantially equivalent to predicate devices in design, function, and range of sizes. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of physical samples (implants) used for each mechanical test. This level of detail is typically found in the full test reports, not the 510(k) summary.
- Data Provenance: The tests are explicitly stated as "Nonclinical testing" conducted to demonstrate performance. This implies laboratory testing on physical samples of the device, rather than data from human subjects or clinical settings, and therefore does not have a "country of origin" for data in the typical sense, nor is it retrospective or prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a mechanical device test, not an AI/CADe device or a study involving human interpretation of medical images. "Ground truth" in this context refers to the measured physical properties and performance against established engineering standards (ASTM F1717). No human experts are used to "establish ground truth" in the way they would for a diagnostic study.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a mechanical test rather than a clinical or diagnostic study, there is no need for an adjudication method. The results are quantitative measurements against defined standards.
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, an MRMC study was not done. This is a mechanical device with no AI component or human-in-the-loop interaction for diagnostic purposes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, this is not an AI/algorithm-based device. Therefore, no standalone algorithm performance testing was conducted.
7. The Type of Ground Truth Used
- Engineering Standards and Specifications: The "ground truth" for this device's performance is based on established engineering test standards (specifically ASTM F1717 for static and dynamic compression and static torsion) and the material specifications (ASTM F136, ISO 5832-3, ASTM F2063). Performance is then compared against that of legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not Applicable. This is a mechanical device, not a machine learning model. There is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, this question is not relevant.
In summary, the provided document describes a 510(k) submission for a traditional mechanical spinal implant. It focuses on demonstrating substantial equivalence to predicate devices through well-established nonclinical (laboratory) mechanical testing, rather than clinical studies or the development and validation of an AI/CADe system.
§ 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.