(198 days)
Zimmer Biomet's Move Forward 3D Motion Simulation Service is an online image analysis service indicated for skeletally mature individuals that enables clinicians to obtain 3D motion simulation reports based on CT or MR image data.
The service can be used by uploading either CT or MR image data of hip joints. The image data is processed by Zimmer Biomet to create 3D anatomy models. These 3D models are then used to perform 3D motion simulations of the hip joint. The report also provides several calculated intersection zones that may improve the simulated range of motion. Move Forward also calculates several morphological shape parameters for each of the 3D anatomy models.
The software generates an interactive report as output. Clinicians do not interact with the image analysis software directly. The image analysis software is only operated by Zimmer Biomet operators who have been specifically trained for this purpose. End users of the generated Move Forward reports are trained medical professionals, including radiologists and orthopedic surgeons.
The Move Forward 3D Motion Service is intended as pre-operative or post-operative software for simulating/evaluating hip preservation surgical treatment options and historical case review, respectively.
The Move Forward 3D Motion Simulation Service is an online image analysis service that enables clinicians to obtain 3D motion simulation reports based on CT or MR image data. This service consists of three modules: CGOnline, Arbiter, and Articulis.
During the segmentation process, 3D bone models of the pelvis and femur bones are created from the image data. Any required editing of the segmentation images are performed by Zimmer Biomet operators. These 3D bone models are then used to perform 3D motion simulations of the hip joint. The 3D motion simulations can be used to visualize rigid shapes such as bones that come into contact with one another, thus potentially limiting range of motion. The system includes several calculated intersection zones that each individually improve the simulated range of motion. The system also calculates several morphological shape parameters for each of the 3D bone models.
The software generates an interactive PDF report as output, which Zimmer Biomet delivers to clinicians on a per case basis through the CGOnline module. In particular, the report that is generated provides information to the clinicians associated with femoroacetabular impingement (FAI). Clinicians do not interact with the image analysis software directly. The Articulis and Arbiter modules are only operated by Zimmer Biomet operators who have been specifically trained for this purpose. End users of the generated Move Forward reports are trained medical professionals, including radiologists and orthopedic surgeons.
The provided text describes the "Move Forward 3D Motion Simulation Service" and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, or information regarding sample sizes, ground truth establishment, expert qualifications, or adjudication methods for performance tests.
The document briefly mentions "Software Verification and Validation activities demonstrate that the Move Forward 3D Motion Simulation Service does not raise any new issues of safety and effectiveness as compared to the predicate device." This is a general statement about V&V, not a specific performance study with acceptance criteria and results.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, or details about the study that proves the device meets the criteria, as this information is not present in the provided text.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).