(108 days)
The Transept™ Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The Transept™ Cervical Plate System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Transept™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. Associated instruments are available to facilitate the implantation of the device. The Transept™ Cervical Plate System implant components are made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
I am sorry, but the provided text is a 510(k) summary for a medical device (Transept™ Cervical Plate System), which is a spinal intervertebral body fixation orthosis.
This type of device is a physical orthopedic implant and instrumentation, not an AI or software-as-a-medical-device (SaMD). The document details mechanical performance testing, materials, and indications for use, but does not contain information related to AI/ML device performance, acceptance criteria for an AI/ML algorithm, or details about clinical studies involving human readers or ground truth establishment for an AI/ML model.
Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details, as these are not relevant to the described medical device and are not present in the provided 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.