(188 days)
Coda is a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
Coda is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
Coda is intended to be used with bone graft and supplemental fixation. Additionally, Coda is intended to be implanted in a paired configuration.
Coda is manufactured from implantable grade titanium 6AL-4V alloy that conforms to ASTM F-136. The device consists of two opposing surfaces that make contact with the bony endplates of the vertebral bodies, and can be adjusted to provide from 0-11 degrees of fordosis.
Coda is available in two lengths and widths, and in various heights to provide the surgeon anatomic flexibility.
Coda is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
The provided text describes a 510(k) summary for a medical device called "Spinal Concepts Inc. Coda®," which is a vertebral body replacement device. This summary focuses on demonstrating substantial equivalence to predicate devices through mechanical testing. It does not present information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device, which is typically what this type of request asks for.
The document is a traditional 510(k) submission for a physical implant, not a software device. Therefore, the requested information about acceptance criteria, study design referencing AI/ML performance metrics (such as sensitivity, specificity, AUC), sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for training sets is not applicable to this submission.
The "Substantial Equivalence" section states: "Mechanical testing demonstrated that Coda® exhibits the functional requirements to support its use as vertebral body replacement under normal physiologic loads in the spine." This is the core 'study' and 'acceptance criteria' for this type of device, focusing on biomechanical performance rather than diagnostic accuracy or AI model performance.
In summary, none of the requested fields regarding acceptance criteria and studies for AI/ML devices can be extracted from the provided text because the document pertains to a physical, non-AI medical implant.
§ 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.