(108 days)
The VENUS Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the 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 radiographic studies),
- spondylolisthesis,
- trauma (i.e. fractures or dislocations),
- tumors,
- deformity (defined as kyphosis, lordosis, or scoliosis),
- pseudarthrosis,
- failed previous fusion,
- spinal stenosis.
WARNING: The VENUS Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The VENUS Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with selftapping and self-drilling bone screws using an anterior approach. Plates are available in a variety of lengths, addressing multiple levels of fixation. Bone screws are available for fixed angle or variable angle implantation in a variety of lengths and diameters. Each screw head forms an autogenic lock to the plate upon insertion, requiring no additional locking mechanism.
Materials:
The plates and screws are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136. The screw retainer clip is fabricated from medical grand nitanol SE 508.
The request asked for information about the acceptance criteria and the study that proves the device meets the acceptance criteria, but the provided text describes a 510(k) summary for a medical device (VENUS Anterior Cervical Plate) and does not include information about an AI/ML device or its performance studies. Therefore, I cannot generate the requested information based on the input provided.
This document describes a medical device called the VENUS Anterior Cervical Plate, which is a traditional, physical implant. It is not an AI/ML device, and thus, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/ML performance (e.g., sensitivity, specificity, F1 score, MRMC studies, training/test sets, ground truth establishment) are not applicable to this submission.
The "Non-clinical Test Summary" states that "Tests performed according to ASTM F2077 indicate that the VENUS Anterior Cervical Plate meets required mechanical strengths." This refers to mechanical testing standards for implants, not AI/ML performance.
The "Clinical Test Summary" explicitly states, "No clinical studies were performed."
Therefore, I cannot fulfill the request to provide information about the acceptance criteria and study proving the device meets them in the context of AI/ML device performance for the given 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.