(213 days)
The C-JAWS cervical compressive staple is intended for anterior cervical intervertebral body fixation. This system is indicated for patients as part of an anterior cervical fusion procedure for the indications listed below. The intended levels for treatment range from C3 to C7.
Indications are limited to patients with degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), at one level, with radiculopathy and/or myelopathy with herniated disc producing symptomatic nerve root and or spinal compression confirmed by radiographic studies and/or with osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and or spinal compression confirmed by radiographic studies.
The C-JAWS cervical compressive staple is limited to one level fusion. A single C-JAWS staple must be implanted per functional segment unit fused. It MUST be used with a cervical interbody fusion device filled with autograft.
WARNING: The C-JAWS cervical compressive staple is not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The C-JAWS cervical compressive staple device is a single component system. The device is shaped to conform to the anatomy of the anterior spine. It features two ridged extension legs, which engage the vertebral bodies and allow secure anchorage of the device and antiback-out using a locking mechanism.
Materials: The C-JAWS cervical compressive staple device is manufactured from CP Titanium (T40. ASTM F-67). The complete C-JAWS cervical compressive staple device contains Class I instruments and non-implantable devices manufactured from stainless steel.
The provided text describes a 510(k) submission for the Medicrea C-JAWS Compressive Cervical Staple, not an AI/ML device. Therefore, it does not contain the information requested about acceptance criteria and studies related to AI/ML device performance.
The document discusses:
- Mechanical Testing: Non-clinical tests were conducted following ASTM F1717 standards (Static Compression, Static Torsion, Dynamic Compression) to demonstrate the device's capability. The document states "Mechanical testing indicates that the C-JAWS cervical compressive staple device is capable of performing in accordance with its intended use." However, specific numerical acceptance criteria and reported performance metrics from these tests are not provided.
- Clinical Study: A clinical study involving 118 patients established an "overall fusion rate of 95.8% and a safety profile directly comparable to standard of care fusion."
Since the request is specifically about AI/ML device performance, and this document describes a physical medical device (cervical staple), a direct answer to the requested table and study details for an AI/ML device cannot be extracted from this text.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.