(227 days)
The MobileCT Viewer software program provides for communication and display of CT, MRI, X-ray medical images on the Apple iPad (4th generation, late 2012) . It is intended for use as a diagnostic, review and analysis tool by trained professionals.
MobileCT Viewer 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 MobileCT Viewer is a software-based Picture Archiving and Communication System (PACS) used with computing servers and specific mobile devices. DICOM-compliant medical images from CT : MRI, X-ray modalities are stored on the server component. MobileCT Viewer retrieves patent image data securely via a network connection with the server. DICOM files are losslessly compressed for network transfer and downloaded by MobileCT Viewer for display on the mobile device component. Communication and display on the mobile device assist trained professionals in the diagnostic interpretation, review and analysis of the medical images.
MobileCT Viewer includes the capability to perform to the displayed image:
- · adjust window width and level (i.e. contrast) values,
- · apply view transforms (e.g. zoom, pan, and rotation),
- · measure distances, and
- · display measurement lines and annotations.
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria in a table format with specific performance metrics. Instead, it describes a functional rather than performance-based evaluation. The "Summary of testing" section indicates:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Evaluate image quality of medical images (CT, MRI, X-ray). | "Results of these studies affirm the diagnostic viewing capabilities of MobileCT Viewer when used as indicated." |
| Meet "performance requirements and specifications" for software functionality. | "In all cases, the software passed its performance requirements and met specifications." A summary of these results is stated to be in section 9.6 and 9.7 of Part XVI (which are not provided in the excerpt). |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the sample size (number of cases/images) used for the test set.
Data Provenance: Not specified, beyond the fact that medical images of the supported modalities (CT, MRI, X-ray) were used. It is not mentioned if the data was retrospective or prospective, or its country of origin.
3. Number of Experts and Qualifications for Ground Truth
The document states: "Nephosity, Inc. has performed multiple studies with qualified medical professionals."
- Number of experts: Not specified ("multiple").
- Qualifications of experts: "qualified medical professionals." No further details on their specific qualifications (e.g., radiologist with X years of experience, board certification) are provided.
4. Adjudication Method
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating the device's performance. It only mentions "qualified medical professionals" evaluating image quality.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not conducted or reported. The study focused on the device's standalone viewing capabilities.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study was conducted. The "Summary of testing" explicitly states that "These medical professional tested MobileCT Viewer by evaluating the image quality of the medical images of the supported modalities (i.e. CT, MRI, X-ray ) under different environmental conditions." This implies that the device's display and manipulation capabilities were tested as a standalone tool for diagnostic viewing.
7. Type of Ground Truth Used
The ground truth appears to be based on expert consensus/opinion regarding the "image quality" and "diagnostic viewing capabilities" of the medical images displayed by the MobileCT Viewer. There is no mention of pathology, outcomes data, or other objective measures for ground truth.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. The MobileCT Viewer is described as a display and manipulation tool, not an AI/CAD algorithm that typically requires a training set for model development.
9. How Ground Truth for Training Set was Established
Since no training set is mentioned (as the device is a viewing application, not an AI algorithm requiring training), this information 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).