(28 days)
The ASPIRON™ S ACP System is intended for anterior vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies);
- · Spondylolisthesis
- · Trauma (including fractures, dislocation)
- · Spinal stenosis
- · Tumors
- · Deformity (defined as scoliosis, kyphosis, or lordosis)
- · Pseudoarthrosis
- · Failed previous fusion
The ASPIRON™ S ACP System consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. All implant components are made from titanium alloy (Ti-6AI-4V ELI) in accordance with ASTM F136. All implants are single use only. The trade name is changed compared to the predicate devices (K182055, K190053).
The provided text is a 510(k) summary for the "ASPIRON™ S ACP System," an anterior cervical plate system intended for spinal fixation. It details the device's indications for use, its substantial equivalence to predicate devices, and the performance testing conducted.
However, the document does not describe any clinical study or specific acceptance criteria related to an AI/ML powered medical device's performance. It focuses on the substantial equivalence of a physical medical implant (an anterior cervical plate) to existing devices, primarily through mechanical performance testing (static compression bending, static torsion, and compression bending fatigue tests according to ASTM F1717).
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets those criteria, as this information is not present in the provided text. The document is a regulatory filing for a traditional medical device, not an AI/ML product.
§ 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.