(85 days)
MedDream is a software medical imaging system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. Software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians, clinicians.
Contraindications: The MedDream is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose medical image data.
MedDream is a software medical imaging system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces.
The provided document is an FDA 510(k) clearance letter for a device named "MedDream". This document is a regulatory approval, not a technical study report that would detail acceptance criteria and a study proving those criteria were met for an AI/CAD/imaging analysis device.
The "MedDream" device is described as "a software medical imaging system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces." It is further stated that the "Software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians, clinicians."
Based on this description, MedDream appears to be a Picture Archiving and Communications System (PACS) or a similar medical image viewing and management software, not an AI or CAD device that performs image analysis and provides diagnostic interpretations requiring specific performance metrics like sensitivity, specificity, or AUC.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for an AI-powered diagnostic or analysis tool. The clearance is based on substantial equivalence to a predicate device for its PACS functionalities, not on the performance of a specific AI algorithm.
Consequently, I cannot fill in the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI component, as this information is not present in the provided FDA clearance letter.
§ 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).