(84 days)
The Affix Next Gen Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions:
· Degenerative disc disease (DDD) - 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)
- · Tumor
The Affix Next Gen Spinous Process Plate System is not intended for stand-alone use.
The Affix Next Gen Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion, and is not intended for stand-alone use. When the Affix II Plate is used as supplemental fixation in interbody fusion procedures, its use is limited to the treatment of degenerative disc disease (DDD) of the lumbosacral spine (L2-S1).
The acceptance criteria and study proving the device meets them are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Measure) | Reported Device Performance (through comparative testing) |
|---|---|
| Static and dynamic axial compression | Substantially equivalent to predicate devices |
| Static torsion | Substantially equivalent to predicate devices |
| Static post-distraction | Substantially equivalent to predicate devices |
| Expulsion | Substantially equivalent to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes nonclinical testing, specifically mechanical testing, to demonstrate substantial equivalence. It does not mention a "test set" in the context of human data or a sample size for such a set. The data provenance is from laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for this device's performance was established through engineering and mechanical testing, not expert consensus on clinical data.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The study performed was nonclinical (mechanical testing) for substantial equivalence.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. This device is a medical implant, not an algorithm, so the concept of "standalone performance" in this context is irrelevant.
7. Type of Ground Truth Used
The ground truth used was based on benchmarking against predicate devices through nonclinical (mechanical) testing. The "truth" was defined by the established performance characteristics and safety profile of the legally marketed predicate devices.
8. Sample Size for the Training Set
Not applicable. The device is a physical medical implant, not a machine learning algorithm, so there is no "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The performance characteristics were established through empirical mechanical testing and comparison to predicate devices, whose safety and efficacy were previously established.
§ 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.