(29 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Altius OCT 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 t
- . 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 Altius OCT System can be linked to the Synergy Spinal System using the Transitional Rods and Rod Connectors from the Altius OCT System.
The Altius OCT System is a titanium system composed of rods, bone screws, hooks, set screws, nuts, cross connectors, 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 the Altius OCT System, which is a spinal interlaminal orthosis fixation device. This type of device is an implant used in surgery and does not typically involve AI or software components requiring the kind of acceptance criteria, performance studies, and ground truth establishment detailed in your request.
The 510(k) process for such a device focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparing indications for use, materials, and biomechanical performance, rather than evaluating AI algorithm performance.
Therefore, I cannot extract the information required in your request (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) from the provided text because it describes a physical medical device (spinal implant) and not an AI or diagnostic software device. The document states:
"{1} COMPARISON TO THE PREDICATE DEVICE
Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Altius OCT System is considered substantially equivalent to the legally marketed predicate device."
This explicitly indicates the type of evaluation performed, which does not align with the questions about AI performance metrics.
§ 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.