(114 days)
The Spineology Spinous Process Plate is a posterior, non-pedicle supplemental fixation device, intended for single level use in the non-cervical spine (T1 - S1). It is intended for single level 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.
• Trauma (i.e., fracture or dislocation)
• Spondylolisthesis
• Tumor
The Spineology Spinous Process Plate is not intended for stand-alone use.
The Spineology Spinous Process Plate is a non-pedicle fixation device that clamps bilaterally to the spinous processes. The three-part titanium device is provided sterile and not intended for stand-alone use.
Here's a breakdown of the acceptance criteria and study information for the Spineology Spinous Process Plate, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Set by ASTM F1717 and internal testing) | Reported Device Performance |
|---|---|
| Static Testing: | Passed |
| - Compression | Passed |
| - Torsion | Passed |
| Dynamic Testing: | Passed |
| - Compression | Passed |
| - Torsion | Passed |
| Static Dissociation Testing | Completed |
| Push-out from foam (plate grip strength) testing | Completed |
Note: The document states that the testing was performed, and the overall conclusion is that the device is "substantially equivalent" in performance characteristics to the predicate products. It does not provide specific numerical thresholds or the exact numerical results for each test. Instead, it indicates successful completion and comparison to predicate devices, implying that the acceptance criteria tied to the performance of those predicate devices were met.
Study Information
-
Sample size used for the test set and the data provenance:
The document does not specify the sample size for any of the tests (static, dynamic, static dissociation, push-out). It also does not mention data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be primarily mechanical/bench testing on the device itself. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device underwent mechanical testing against established standards (ASTM F1717) and comparative testing against predicate devices. There is no mention of "ground truth" derived from human experts in the context of clinical or image-based assessment as this is a spinal implant. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this was mechanical testing, not a clinical study involving human judgment that would require adjudication. -
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:
Not applicable. This document pertains to a spinal implant (mechanical device), not an imaging or AI-assisted diagnostic device. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm or software. Its performance is assessed through mechanical and physical testing. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the mechanical testing, the "ground truth" (or basis for comparison) was established engineering standards (ASTM F1717) and the performance of legally marketed predicate devices (CD HORIZON SPIRE™ and Lanx Aspen). The performance of the new device was compared to these established benchmarks to demonstrate substantial equivalence. -
The sample size for the training set:
Not applicable. This is a physical medical device undergoing mechanical testing, not a machine learning model requiring a training set. -
How the ground truth for the training set was established:
Not applicable, for the same reason as above.
§ 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.