(767 days)
The intended use of the Orthobond Mariner Pedicle Screw System in a posterior or anterolateral approach is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
The indications for use are as follows:
- . Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- Spondylolisthesis. .
- Trauma (i.e., fracture or dislocation), .
- Spinal stenosis. .
- . Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- Spinal tumor. .
- Pseudarthrosis, and/or .
- Failed previous fusion. .
The Orthobond coating is intended to reduce bacterial contamination prior to implantation resulting from deposition in the operating room on the surface of the device. The clinical impact associated with the Orthobond coating, including prevention of infection or reduction of infection risk in patients, has not been evaluated in human clinical trials. The Orthobond coating is not intended to treat existing infections and does not act within or on the body.
The device is a pedicle screw system, with instrumentation for implantation and removal, intended for spinal fusion as shown in Figure 1. The Ti6Al4V ELI implants are coated with 12-Methacryloyloxydodecyl Pyridinium Bromide (MDPB), a type of quaternary ammonium compound, which is intended to reduce bacterial contamination on the surface of the implant prior to implantation which may occur from deposition in the operating environment. Based on in vitro testing, this coating may result in immobilization and/or lysis of some challenge organisms. The pedicle screw system is comprised of screws, rods, connectors, and hooks of various sizes. The instruments included in the Mariner Pedicle Screw System facilitate the placement, adjustment, final locking, and removal, if necessary, of the system implants, and accessories to the system include trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
The provided text describes the regulatory information and technical specifications of the Orthobond Mariner Pedicle Screw System, particularly focusing on its non-clinical and animal studies to demonstrate safety and performance. However, it does not contain any information about a standalone AI algorithm, a multi-reader multi-case (MRMC) comparative effectiveness study, or a study involving human readers or expert consensus for ground truth establishment related to an AI device.
The document is solely about a physical medical device (pedicle screw system with a coating) and its mechanical, biological, and material performance testing, not an AI/ML powered device. Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI-powered device from the provided text.
The text specifies performance criteria for the physical device based on bench testing (e.g., static and dynamic compression bending, static torsion) and animal studies, but these are not related to an AI/ML algorithm's performance.
If you have a document describing an AI device and its validation studies, please provide that.
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