(79 days)
Fixation of C1-C2 in case of fracture or multi-operated back.
The J.B.S. Posterior C1-C2 Clamp System is a single-use. temporary device used for fixation of the C1-C2 vertebrae. The System is to be removed after fusion occurs. It consists of a cervical hook, a superior hook, a linking screw and a locking screw. All these components are made of surgical implant titanium with the composition Ti-6AL-4V ELI according to ASTM-136-92 or ISO 5832-3-90.
The provided text describes a medical device called the "J.B.S. POSTERIOR C1-C2 CLAMP SYSTEM®", which is a spinal fixation device. However, the text is a 510(K) summary for a medical device and does not contain any information about acceptance criteria or a study proving that the device meets those criteria, particularly in the context of an AI/algorithm-driven device.
The request asks for information relevant to the testing and evaluation of an AI-driven medical device, including aspects like sample size for test and training sets, ground truth establishment, expert qualifications, and multi-reader multi-case studies. These concepts are not applicable to the non-AI, mechanical spinal clamp system described in the input.
Therefore, I cannot fulfill the request using the provided input. The input describes a physical medical implant, not an AI/algorithm device.
§ 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.