(82 days)
The Swift Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. These systems are indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.
The Swift Anterior Cervical Plate System consists of an assortment of plates and screws.
The Swift Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The provided document is a 510(k) summary for the Swift Anterior Cervical Plate System, a spinal implant. It describes the device, its intended use, and its predicate devices. However, this document does not contain explicit acceptance criteria or details of a study that proves the device meets such criteria in the format requested for AI/algorithm performance.
Instead, it primarily focuses on establishing substantial equivalence to previously cleared predicate devices for regulatory clearance. The "Performance Data" section merely states: "Performance data were submitted to characterize the Swift Anterior Cervical Plate System." This is a very general statement and does not provide specifics about the nature of the data, the tests performed, or the results against any defined acceptance criteria, as would be expected for evaluating an AI-based medical device.
Therefore, I cannot populate the requested table and answer the specific questions about "acceptance criteria," "reported device performance," "sample size," "experts," "adjudication," "MRMC study," "standalone performance," "ground truth," and "training set" based solely on the information provided in this document.
This document is for a mechanical implant and the regulatory review process primarily relies on manufacturing standards, material testing, and comparison to predicate devices, rather than clinical performance studies with specific statistical endpoints and ground truth determinations that are typical for AI/algorithmic devices.
§ 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.