(243 days)
The VuePoint® OCT System is intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), and is indicated for: (1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) Degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) Fracture/Dislocation, (4) Spinal Stenosis, (5) Atlantoaxial fracture with instability, (6) Occipitocervical dislocation, (7) Spinal tumor and/or (8) Revision of previous cervical spine surgery.
The occipital bone screws are limited to occipital fixation only.
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The VuePoint OCT System can also be linked to the NuVasive SpheRx Spinal System via the rod to rod connectors or transition rods.
The NuVasive VuePoint OCT System consists of a variety of shapes and sizes of screws, rods, offset connectors, set screws, and cross connectors which can be rigidly locked in a variety of configurations to accommodate patient anatomy.
Here's a breakdown of the acceptance criteria and study information for the NuVasive® VuePoint® OCT System based on the provided 510(k) summary:
This device did not involve AI or algorithms; it is a spinal fixation system. Therefore, many of the requested categories related to AI performance, ground truth establishment, expert adjudication, MRMC studies, and training sets are not applicable. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to predicate devices through biomechanical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Measure) | Reported Device Performance (Goal/Outcome) |
|---|---|
| Biomechanical Testing | |
| Static and dynamic torsion | Met or exceeded the performance of the predicate device (per ASTM draft WK455-Z9592Z). |
| Static and dynamic compression | Met or exceeded the performance of the predicate device (per ASTM draft WK455-Z9592Z). |
| Interconnection strength | Met or exceeded the performance of the predicate device (per ASTM F1798). |
| Overall Substantial Equivalence | Demonstrated to be substantially equivalent to legally marketed predicate devices in terms of safety and effectiveness for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (number of constructs or test specimens) used for each biomechanical test.
- Data Provenance: Not applicable in the context of clinical data. The tests are nonclinical (laboratory-based biomechanical tests) performed to demonstrate mechanical equivalence. Country of origin for data is not specified, but the submission is to the U.S. FDA, implying adherence to U.S. recognized standards. The study is nonclinical (in-vitro testing).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This device is a spinal fixation appliance, and the "ground truth" for its performance is established by standardized biomechanical tests demonstrating its physical and mechanical properties, not by human expert opinion or clinical outcomes in the traditional sense. The "ground truth" is adherence to established engineering standards for strength and durability.
4. Adjudication Method for the Test Set
- Not applicable. There was no human adjudication of "cases" or "ground truth" as this was a nonclinical biomechanical study. The adjudication is against the performance of predicate devices and relevant ASTM standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No. This is not an AI-powered device. It is a physical spinal implant system. Therefore, MRMC studies and AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
- Nonclinical Biomechanical Performance. The "ground truth" for this device's performance is its ability to meet or exceed the biomechanical performance (static and dynamic torsion, compression, interconnection strength) of legally marketed predicate devices, as measured by established ASTM (American Society for Testing and Materials) standards.
8. The Sample Size for the Training Set
- Not applicable. This non-AI device does not have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This non-AI device does not have a "training set" or "ground truth" established for training in the context of machine learning.
§ 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.