(169 days)
The C-JAWS Cervical Compressive Mini Frame, in conjunction with traditional rigid fixation, is intended for use in cervical fusion procedures as a means to maintain the relative position of weak bony tissue such as allograft or auto grafts. This device is not intended for load bearing applications.
The C-JAWS implant is a single component system of anterior cervical anchoring. The staple is uniquely shaped to conform to the anatomy of the anterior of from and one notched arms, which engage the vertebral bodies and works by plastic deformation of the implants body. The staples are available in four sizes, 15mm and 20mm for the height, 14 and 17mm for the arms length. The C-JAWS implant is manufactured from CP titanium and has a smooth and dirinh.
The provided text describes a medical device, the C-JAWS Cervical Compressive Mini Frame, and its substantial equivalence to predicate devices, but it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria.
The document is a 510(k) Premarket Notification summary for a spinal intervertebral body fixation orthosis. It primarily focuses on:
- Device Identification: Trade name, common name, classification, product code, submitter, and predicate devices.
- Device Description: Material, shape, and sizes.
- Intended Use: For cervical fusion procedures to maintain relative position of weak bony tissue, not for load-bearing.
- Performance Data: States that "Biomechanical testing, including pull out fixation tests were conducted." However, it does not provide any details about the acceptance criteria for these tests, the results, or how they demonstrate the device meets any specific performance standard.
- Substantial Equivalence: Claims equivalence to two predicate devices.
Therefore, I cannot provide the requested table and study details. The information about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set information is not present in the given text.
To be clear: The document states that biomechanical testing was done, but it does not report the acceptance criteria or the specific performance results in a way that allows for a table comparing them.
§ 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.