(44 days)
Cure™ 2.0 Anterior Cervical Plate (ACP) System is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radies), Spondylolisthesis, Trauma (i.e., fractures or dislocations), Deformity (defined as kyphosis, lordosis), Pseudarthrosis, and Failed previous fusions.
Cure™ 2.0 Anterior Cervical Plate (ACP) System is composed of plates in a wide range of sizes to coincide with the surgical approach and screws that are available in multiple lengths and diameters.
Cure™ 2.0 Anterior Cervical Plate (ACP) System is manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
I am sorry, but the provided text is a 510(k) summary for a medical device (Cure™ 2.0 Anterior Cervical Plate (ACP) System). This type of document focuses on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical testing.
The information you requested, such as acceptance criteria, reported device performance (with specific metrics like sensitivity, specificity, or accuracy), details about test sets (sample size, data provenance), ground truth establishment (number of experts, qualifications, adjudication), MRMC studies, standalone algorithm performance, and training set details, are typically found in studies for AI/ML-enabled devices or diagnostic software.
The Cure™ 2.0 Anterior Cervical Plate (ACP) System is a physical implant, and its clearance is based on mechanical testing (ASTM F1717) to ensure it performs equivalently to an existing device. Therefore, the requested information about AI/ML device performance metrics and study design elements is not applicable to this document.
§ 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.