(163 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Interpore Cross International ICI Occipito-Cervico-Thoracic (OCT) Rod and Plate System is indicated for:
- . DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis .
- . Spinal stenosis
- . Fracture/dislocation
- Atlantoaxial fracture with instability ●
- . Occipitocervical dislocation
- . Revision of previous cervical spine surgery
- Tumors
The occipital bone screws are limited to occipital fixation only.
The Interpore Cross International ICI Occipito-Cervico-Thoracic (OCT) Rod and Plate System is a titanium system composed of rods, bone screws, hooks, set screws, nuts, cross connectors, and plates. For occipito-cervico-thoracic fusion, the occipital plate is fixed to the occiput with bone screws. The pre-bent rod is cut to the appropriate length. Bone screws are placed in the thoracic spine (T1-T3) and hooks are placed in the cervical spine. The rod is inserted and the construct is locked with screws and nuts. Cross connectors can be added to the construct.
The provided text is a 510(k) summary for a medical device (Interpore Cross International (ICI) Occipito-Cervico-Thoracic (OCT) Rod and Plate System). However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.
This type of submission primarily focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than presenting a performance study with acceptance criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study proving the device meets those criteria, as this information is not present in the provided document.
§ 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.