(87 days)
The Michelson Anterior Cervical Plate System is intended to provide stability while allowing the cervical spine to fuse for the following indications:
- Instability caused by trauma (including fractures); .
- Instability associated with correction of cervical lordosis, scoliosis and kyphosis . deformity;
- Instability associated with tumors; .
- Instability associated with degenerative disk diseases defined as back pain of . discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
- . Instability from failed previous fusions.
The Michelson Anterior Cervical Plate System consists of a cervical plate, locking cap and bone screw. The locking cap is preassembled onto the plate.
The provided text describes a medical device, the Michelson Anterior Cervical Plate System, and its regulatory clearance (510(k)). However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of the requested AI/algorithm performance analysis.
The document is a 510(k) summary and an FDA clearance letter for a physical medical device (an anterior cervical plate system). It discusses:
- Intended Use/Indications for Use: What the device is designed to do (provide stability for cervical spine fusion due to various conditions like trauma, deformity, tumors, degenerative disk diseases, failed fusions).
- Materials: Titanium alloys.
- Testing Summary: A brief statement that "Submitted testing demonstrates that the Michelson Anterior Cervical Plate System fatigue strength is comparable to a predicate device and adequate for its intended use." This is a summary of mechanical and material testing, not an AI/algorithm performance study.
- Predicate Device: The ORION Anterior Cervical Plate, Synthes CSLP System.
- Regulatory Classification and Warnings: Class II, with specific warnings against pedicular screw fixation.
Therefore, it is impossible to extract the requested information about acceptance criteria for an AI device and a study proving it meets those criteria from this document. The document pertains to a physical surgical implant, not an AI-powered diagnostic or assistive tool.
§ 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.