(105 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Summit Occipito-Cervico-Thoracic (OCT) Spinal System is indicated for:
- ddd (neck pain of discogenic origin with degeneration of the disc as . confirmed by patient history and radiographic studies)
- spondylolisthesis t
- spinal stenosis .
- fracture/dislocation .
- atlanto/axial fracture with instability .
- occipitocervical dislocation .
- revision of previous cervical spine surgery
- tumors .
The occipital bone screws are limited to occipital fixation only.
The use of the minipolyaxial 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 Songer Cable System to be used with the Summit OCT Spinal System allows for wire/cable attachment to the posterior cervical spine.
The Summit OCT Spinal System consists of rods, plates, nuts, bolts, washers, bone screws, transverse rod connectors, cable connectors, set screws, minipolyaxial screws and Songer Cables. For occipitocervicothoracic fusion, the transition rod is bent and cut to the appropriate length. The occipital plate is fixed to the occiput with bone screws and the transition rod is attached to the plate by a locking mechanism. This locking mechanism consists of a bolt and a washer which are free to rotate and translate along a slot in the occipital plates. The rod loads from the top and is fixed and locked into place with a mini outer nut. Sub-axially, cable connectors are fixed to the transition rod and attached to the spine via sublaminar cabling looped through the cable connectors. The end of the construct is stabilized with polyaxial screws and mini outer nuts to the upper thoracic spine, as required.
The provided text describes a medical device, the Summit Occipito-Cervico-Thoracic (OCT) Spinal System, and its submission for 510(k) clearance. However, it does not contain acceptance criteria for device performance nor any details of a study structured to prove device performance against such criteria.
The "Performance Data" section merely states that "Biomechanical testing, including static axial slippage, static torsion slippage, static and dynamic construct axial compression bending and static and dynamic construct torsion, were conducted." This indicates that tests were performed, but does not provide specific acceptance criteria, test results, or details about the study design that would allow for an assessment of whether the device met any defined performance thresholds.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I fill in a table of acceptance criteria and reported performance, or provide details on sample size, ground truth, expert involvement, or comparative effectiveness studies. These types of detailed performance data and study breakdowns are typically found in a more comprehensive premarket submission or a scientific publication rather than the summary provided here.
§ 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.