(56 days)
The UniVise™ Spinous Process Fixation Plate 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 spinous processes for the purposes 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. The UniVise™ Spinous Process Fixation Plate is intended for use with bone graft and is not intended for stand alone use.
The UniVise™ Spinous Process Fixation Plate is a one-piece bilateral locking plate device which attaches to the posterior non-cervical spine by securely grasping two adjacent spinous processes. The S.P.F.P is available in multiple sizes to accommodate different anatomical requirements, and it is composed entirely of titanium 6Al-4V alloy. The UniVise™ Spinous Process Fixation Plate may be implanted by either conventional surgical methods, or via minimally-invasive techniques. Proprietary manual instrumentation for implantation of the S.P.F.P is available for both conventional and minimally-invasive surgical procedures. When the UniVise™ Spinous Process Fixation 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).
Please find the acceptance criteria and study information for the UniVise™ Spinous Process Fixation Plate below:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | "The UniVise™ Spinous Process Fixation Plate is substantially equivalent and has equivalent technological characteristics to other predicate devices cleared by the FDA as demonstrated through comparison in areas such as design, labeling, intended use, material composition, and function." |
| Safety and Effectiveness | "The UniVise™ Spinous Process Fixation Plate is as safe and effective as the predicate devices as it has the same intended uses and similar indications for use, technological characteristics, and principles of operation as its predicate devices." |
2. Sample size used for the test set and the data provenance
No specific test set or data provenance is mentioned in the provided text. The submission is a 510(k) for a modification to the surgical technique of an already cleared device, and no new performance data was generated. The claim of substantial equivalence is based on comparison to predicate devices, not on new testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The submission is focused on demonstrating substantial equivalence to predicate devices, not on a study requiring expert-established ground truth.
4. Adjudication method for the test set
Not applicable. There was no test set requiring adjudication in this submission.
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
Not applicable. This device is a medical implant (Spinous Process Fixation Plate), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a medical implant, not an algorithm, so standalone algorithm performance is not relevant.
7. The type of ground truth used
The "ground truth" for this submission is substantial equivalence to legally marketed predicate devices. This is established through comparative analysis of design, labeling, intended use, material composition, and function, rather than an independent clinical or pathological ground truth as would be used for a diagnostic device.
8. The sample size for the training set
Not applicable. The submission refers to a medical implant and its surgical technique, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There was no training set in this submission.
§ 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.