Primary Outcome Measures:
- Image quality of images that are obtained from scanning subjects who have metallic MR Safe or MR Conditional implants, will be evaluated on a pass/fail basis. [ Time Frame: Within the first hour after scanning ] [ Designated as safety issue: No ]
Review of real-time and post-acquisition technical assessment will occur. The assessment of images will be made by scientists, engineers and radiology technologists. Validation activities will consist of a comparison of the observed images with the prospective acceptance criteria to determine if each specific test results in a pass or fail. There are no statistical tests and no efficacy endpoints.
Secondary Outcome Measures:
- The ease of use and optimization of the MR device in imaging of subjects with metallic implants will be assessed. [ Time Frame: Within one hour of scanning ] [ Designated as safety issue: No ]
Software programs, data processing software and other types of MR system accessory hardware and software components will be tested and evaluated for how easy and problem-free they are to use and optimize for imaging of subjects with a metallic implant. Once this is established, validation of user requirements and specifications will be performed in accordance with Good Manufacturing Practice (GMP) design control requirements.
The technology comprising Magnetic Resonance (MR) imaging systems and accessories is under continuous development in order to improve the quality of images, speed of acquisition, and usability of MR devices applied to image subjects with metallic orthopedic implants. Collection of in vivo human data throughout the product development and maintenance lifecycle plays an important role in enabling the technology to be investigated, optimized, and validated.
This is a pre-market investigation involving commercially available devices, investigational devices, and commercial devices modified with investigational components. The Study will be conducted for three years, over which time a number of endpoints will be collected for various devices under development.