(86 days)
It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.
- The Zodiac DynaMo Semi-Rigid Spinal System when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
a. Patients having fractures of the thoracic and lumbar spine.
b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis). - The Zodiac DynaMo Semi-Rigid Spinal System , when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
- In addition, the Zodiac DynaMo Semi-Rigid Spinal System , when used as a pedicle screw fixation system is intended for:
a. Patients receiving only autogenous bone graft.
b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint. - The Zodiac DynaMo Semi-Rigid Spinal System , when used as a laminar hook and bone screw system is intended for:
a. Patients having fractures of thoracic and lumbar spine.
b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).
The Zodiac DynaMo Semi-Rigid Spinal System is a top loading anterior/posterior spinal fixation system consisting of various types and sizes of implantable components that are assembled to create a rigid spinal construct.
The Zodiac DynaMo Semi-Rigid Spinal System is a spinal fixation system. The testing performed was to demonstrate the substantial equivalence of its mechanical performance to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance is substantially equivalent to the predicate device. | Mechanical and dynamic testing results demonstrated that the Zodiac DynaMo Semi-Rigid Spinal System's mechanical performance is substantially equivalent to the predicate device (Moss-Miami Spinal System, K030383). |
2. Sample size used for the test set and the data provenance
The document indicates that "Mechanical and dynamic testing" was performed, but does not specify the sample size used for the test set.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, as the study involves mechanical testing of the device itself rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the study involved mechanical testing of a spinal fixation system, not a diagnostic or prognostic device requiring expert-established ground truth from clinical data.
4. Adjudication method for the test set
This question is not applicable as the study involved mechanical testing, not a clinical study requiring adjudication of expert opinions.
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
This question is not applicable as this device is a mechanical spinal fixation system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as this device is a mechanical spinal fixation system and does not involve an algorithm.
7. The type of ground truth used
The ground truth for this device's performance is established through mechanical and dynamic testing against predefined engineering standards and comparison to a legally marketed predicate device's performance.
8. The sample size for the training set
This question is not applicable as this is a mechanical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable as this is a mechanical device and does not involve a training set.
§ 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.