(39 days)
The Mobile MIM software program is used for the registration, fusion, and/or display for diagnosis of medical images from only the following modalities: SPECT, PET, CT, and MRI.
Mobile MIM provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
This device is not to be used for mammography.
The Mobile MIM software program is used for the registration, fusion, and/or display for diagnosis of medical images from only the following modalities: SPECT, PET, CT, and MRI.
Mobile MIM provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.
The software is not to be used for mammography.
It includes the capability to measure distance and image intensity values such as Standardized Uptake Value, displays measurement lines, annotations and regions of interest, and provides window/level, zoom/pan, and fusion blending control functionality.
Mobile MIM retrieves patient image data securely via a network connection with a MIM workstation or server. Processed DICOM images from the workstation or server are losslessly compressed for network transfer and downloaded by Mobile MIM for display.
Mobile MIM operates on "off-the-shelf" portable hardware devices and is therefore subject to factors not typical for reading room workstations (e.g. screen size, environmental variability, network dependencies, etc.). It is therefore required that the user follows the operating instructions properly and utilizes the risk mitigation features in order to make decisions safely and effectively.
The provided document describes the Mobile MIM software, a medical imaging software for display and diagnosis of medical images (SPECT, PET, CT, and MRI). It is intended for wireless and portable access when a full workstation is unavailable and is not for mammography.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Display Performance: Contrast response, luminosity, resolution, and noise according to IEC 62563-1 and TG18 guidelines, after calibration. | All testing passed requirements following the Mobile MIM's calibration procedure. |
| Diagnostic Image Viewing Capabilities: Performance for diagnosis with qualified radiologists using various modalities (MRI, CT, SPECT, PET) under different environmental conditions. | Results of these studies affirm the diagnostic image viewing capabilities of Mobile MIM when used as indicated. |
| Software Functionality: Verification, validation, and functional testing to meet performance requirements and specifications. | In all cases, the software passed its performance requirements and met specifications. |
2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set (number of images or cases).
The data provenance is also not explicitly detailed, but the studies were conducted internally by MIM Software Inc. with "qualified radiologists" and "a variety of modalities, specifically MRI, CT, SPECT, and PET." No information on the country of origin or whether the data was retrospective or prospective is provided.
3. Number of Experts and Qualifications for Ground Truth Establishment:
The document mentions "multiple studies with qualified radiologists." It does not specify the exact number of radiologists or their specific qualifications (e.g., years of experience, subspecialty) beyond being "qualified."
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth from the radiologists' readings. It simply states that "results of these studies affirm the diagnostic image viewing capabilities."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not explicitly mention a multi-reader, multi-case (MRMC) comparative effectiveness study to assess how much human readers improve with AI vs. without AI assistance. The testing focused on the standalone performance and diagnostic viewing capabilities of Mobile MIM.
6. Standalone Performance Study:
Yes, a standalone study (algorithm only without human-in-the-loop performance) was done for display performance, measuring contrast response, luminosity, resolution, and noise using objective standards (IEC 62563-1 and TG18 guidelines). The document also mentions "functional testing on the Mobile MIM software" which implies standalone software performance evaluation.
7. Type of Ground Truth Used:
For the "diagnostic image viewing capabilities" studies, the ground truth was implicitly established by expert consensus/opinion from "qualified radiologists" who affirmed the capabilities. For display performance, the ground truth was based on objective measurements against established standards (IEC 62563-1 and TG18 guidelines).
8. Sample Size for the Training Set:
The document does not provide any information about the sample size for a training set. Given that Mobile MIM is described as medical imaging software for display, registration, fusion, and measurement, rather than an AI-driven diagnostic algorithm, it's highly probable that a "training set" in the machine learning sense was not applicable or not the primary focus of these performance data. The device's function is more akin to a viewing and manipulation tool than an automated diagnostic tool requiring extensive AI model training.
9. How Ground Truth for the Training Set Was Established:
As no training set is mentioned or implied for an AI model, the method for establishing ground truth for a training set is not applicable and not provided in the document.
§ 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).