(128 days)
The NuVasive® Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. It is not intended for stand-alone use.
The NuVasive® Spinous Process Plate System features plates with spikes under the plate to help resist plate rotation after implantation.
The NuVasive® Spinous Process Plate System is a medical device. As such, the acceptance criteria and study detailed here pertain to its mechanical performance and substantial equivalence to existing devices, rather than AI/algorithm performance.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | Data demonstrated substantial equivalence in indications for use, design, material, and function. Mechanical testing was presented. |
2. Sample Size Used for the Test Set and Data Provenance
The document indicates that non-clinical mechanical testing was performed. However, it does not specify the sample size used for these tests. There is no information provided regarding data provenance (e.g., country of origin or whether it was retrospective/prospective), as this typically applies to clinical data, which was not the primary basis for this review.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not indicate the use of experts to establish ground truth for a "test set" in the context of device performance in the same way an AI model might. The evaluation relies on mechanical testing data for device performance and comparison to predicate devices, which is typically assessed by engineers and regulatory reviewers, not medical experts defining a "ground truth" for diagnostic accuracy.
4. Adjudication Method for the Test Set
Since the evaluation primarily involved non-clinical mechanical testing and comparison to predicate devices, there was no adjudication method described similar to those used in clinical or AI studies (e.g., 2+1, 3+1). The "ground truth" for mechanical testing is typically based on established engineering standards and measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is relevant for evaluating the impact of AI assistance on human readers in diagnostic tasks, which is not applicable to a spinal implant system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone performance study was conducted because this device is a physical medical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance was:
- Mechanical Testing Results: Performance of the device against engineering specifications and relevant standards.
- Substantial Equivalence to Predicate Devices: This serves as a primary form of "ground truth" where the new device's characteristics (indications for use, design, material, and function) are directly compared to those of legally marketed, already accepted devices.
8. The Sample Size for the Training Set
This concept is not applicable. The NuVasive® Spinous Process Plate System is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable. As mentioned, there is no training set for a physical medical device.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.