(137 days)
Mimics Cardiac Planner is intended to be used as a pre-procedural planning software to screen and plan structural heart and vascular procedures based on DICOM compliant medical images. Mimics Cardiac Planner allows the clinician to visualize, measure, annotate and edit pre-procedural plan data. The software can be used to evaluate the sizing, positioning and delivery pathway of structural heart and vascular devices.
Mimics Cardiac Planner should be used in conjunction with other diagnostic tools and expert clinical judgement.
The Mimics Cardiac Planner is an online planning software, which allows the clinician to review and adjust a plan for a structural heart or vascular procedures based on DICOM images, 3D models and landmarks. The software guides the clinician through different steps of the cardio-vascular workflow, where the relevant information, like 3D models of anatomy and devices, images, landmarks and measurements are presented.
The software enables the clinician to review the anatomy and relevant workflow specific predefined set of measurements, evaluate the device size and position, assess the delivery pathway and prepare the fluoroscopy angles for the procedure.
The software provides the tools to adjust all predefined measurements, and to perform custom measurements.
The software is integrated with a Medical Device Data System, which is responsible for the case management and user management.
The provided text does not contain detailed acceptance criteria and corresponding study results for the device's performance. It primarily focuses on the regulatory aspects of the 510(k) submission, including:
- Device Name: Mimics Cardiac Planner
- Intended Use: Pre-procedural planning software for structural heart and vascular procedures based on DICOM images, allowing visualization, measurement, annotation, and editing of pre-procedural plan data. It can evaluate sizing, positioning, and delivery pathway of devices.
- Regulatory Classification: Class II, Product Code LLZ (Medical Image Management And Processing System)
- Predicate Device: Mimics Enlight (K190874)
- Reference Device: SurgiCase Shoulder Planner (K220452)
- Technological Characteristics Comparison: Discusses similarities and differences with predicate and reference devices, particularly concerning functionality (e.g., input requirements, cloud vs. desktop software) and underlying technology.
- Performance Data Summary: States that "Software verification and validation were performed, and documentation was provided following the FDA guidance 'Content of Premarket Submissions for Device Software Functions.' This includes verification against defined requirements, and validation against user needs."
However, it does not provide any specific acceptance criteria (e.g., numerical thresholds for accuracy, precision, sensitivity, specificity) or the quantitative results of any performance studies (e.g., clinical trials, reader studies, phantom studies).
Therefore, I cannot create the requested table of acceptance criteria and reported device performance or answer the detailed questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. The document only broadly states that verification and validation were performed to demonstrate substantial equivalence, but the specifics of those evaluations are not included here.
§ 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).