(68 days)
The Aggeris™-C device is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
- Pseudoarthrosis
- Revision of previous surgery
The Aggeris™-C is designed for use as a cervical plate. The device is manufactured from medical grade Titanium alloy. The device has a shape which restores the intervertebral height and lordosis. The device consists of a variety of bone screws and cervical plates provided in a variety of shapes and sizes of with rounded corners, bone screw holes, and a screw locking system. The plates are provided in a variety of lengths, allowing treatment from 1 to 5 levels. The Aggeris™-C plates, as well as the bone screws, are made from Ti alloy conforming to ASTM F136.
This document describes the Clariance Aggeris™-C device, specifically a spinal intervertebral body fixation orthosis. However, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for software-based medical devices or AI/ML components.
The text focuses on hardware-related regulatory submission details for a physical medical device (spinal implant), including:
- Device name, classification, and regulation details.
- Indications for use for a cervical plate.
- Technological characteristics (materials, design).
- Performance data related to biocompatibility, sterility, cleaning, and mechanical testing (static and dynamic axial compression, static torsion) of the physical implant.
- Comparison to a predicate device for substantial equivalence, again for the physical implant.
There is no mention of an AI/ML component, software, or any study involving human-in-the-loop performance, standalone algorithm performance, or ground truth establishment for diagnostic or predictive purposes.
Therefore, I cannot provide the requested information based on the provided text. The questions posed in your prompt (e.g., sample size for test/training set, number of experts for ground truth, MRMC study, standalone performance) are relevant to AI/ML medical devices, not to the type of physical device and regulatory submission described here.
§ 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.