(272 days)
QMENTA Care Platform Family is a software medical imaging system used to receive DICOM images 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. QMENTA Care Platform Family consists of two components:
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A Storage/archiving server for the retrieval of DICOM images from CT and MR modality data, and also PET/CT data from PACS and/or OS-based file storage.
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A workflow server that allows to integrate legally marketed applications for clinical use into the OMENTA Care Platform Family. The applications are geared toward specific types of image analysis and are marketed with corresponding names.
The results may be saved to a DICOM image file and may be further visualized on an imaging workstation.
QMENTA Care Platform Family is designed to aid suitably qualified physicians, who will base their diagnoses on training and protocols that do not necessarily rely on image maps or image quantifications.
QMENTA Care Platform Family (QMENTA Care) is a software medical imaging system that runs on standard computer hardware that may compute legally marketed applications for clinical use based on DICOM images captured via MR, CT and PET modalities.
These actions include:
- Retrieval of MR, CT and PET DICOM image studies from PACS and/or OS-based file storage
- . Computation of legally marketed applications for clinical use
- Generation of reports summarizing the computations performed
The resulting output may be provided in a standard DICOM format as additional MR series with possible computed outputs (image overlays, numerical reports, and/or other results) that can be displayed on third-party DICOM workstations and Picture Archive and Communications Systems (PACS).
From a workflow perspective, QMENTA Care can operate as a computing appliance that is capable of supporting DICOM file transfer for input and output of results.
The legally marketed applications for clinical use can be "plugged in" into the QMENTA Care Platform Family. The applications may be geared toward specific types of image analysis and may be marketed with corresponding names.
The provided text describes the QMENTA Care Platform Family, a software medical imaging system, and its FDA 510(k) clearance. However, it does not describe a study with specific acceptance criteria and reported device performance metrics related to the accuracy or effectiveness of an AI algorithm in performing a diagnostic task.
Instead, the document details the platform's functionality (receiving, organizing, storing, and making DICOM images and textual reports available, and integrating legally marketed applications for clinical use). The "Performance data" section focuses on software verification and validation, risk management, and usability testing as per general medical device software development standards.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance for an AI algorithm, or details about patient sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, because this information is not present in the provided document. The device described is a platform for managing and integrating other applications, not a specific AI diagnostic algorithm with performance metrics.
The document states: "The subject of this premarket submission, QMENTA Care Platform Family, did not require clinical studies to support substantial equivalence." This further confirms that it is a platform for managing data and integrated applications, rather than a device with a direct diagnostic AI component whose performance would be assessed through the metrics requested.
In summary, the provided text describes a software platform, not an AI algorithm with specific clinical performance metrics.
§ 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).