(119 days)
BriefCase-Quantification is a radiological image management and processing system software indicated for use in the analysis of contrast-enhanced CT exams that include the aorta in adults or transitional adolescents aged 18 and older.
BriefCase-Quantification of Aortic Measurement (M-Aorta) is intended to assist hospital networks and appropriately trained medical specialists by providing the user with aortic diameter measurements across the aorta. BriefCase-Quantification is indicated to evaluate normal and aneurysmal aortas and is not intended to evaluate post-operative aortas.
The device provides the following assessments:
- Aortic measurements at 10 anatomical landmarks;
- Maximum aortic diameter of the abdominal aorta, descending aorta and ascending aorta.
The BriefCase-Quantification results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. These measurements are unofficial, are not final, and are subject to change after review by a radiologist. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing full images per the standard of care.
BriefCase-Quantification is a radiological medical image management and processing device. The software consists of a single module based on an algorithm programmed component and is intended to run on a linux-based server in a cloud environment.
The BriefCase-Quantification receives filtered DICOM Images, and processes them chronologically by running the algorithm on relevant series to measure the maximum abdominal aortic diameter. Following the AI processing, the output of the algorithm analysis is transferred to an image review software (desktop application), and forwarded to user review in the PACS.
The BriefCase-Quantification produces images and tabular views of the landmarks and segments selected per installation to be displayed in the image review software, provided by the Image Communication Platform integrated with Briefcase-Quantification. The diameter marking is not intended to be a final output, but serves the purpose of visualization and measurement. The original, unmarked series remains available in the PACS as well. The preview image presents an unofficial and not final measurement, and the user is instructed to review the full image and any other clinical information before making a clinical decision. The image includes a disclaimer: "Not for diagnostic use. The measurement is unofficial, not final, and must be reviewed by a radiologist."
BriefCase-Quantification is not intended to evaluate post-operative aortas.
Here's an analysis of the acceptance criteria and study proving device performance, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric / Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Endpoint: Mean Absolute Error (MAE) between ground truth measurement and algorithm across all landmarks and studies. | 1.88 mm (95% CI: 1.78 mm, 1.99 mm). |
| (This was "below the prespecified performance goal," thus achieving the primary endpoint. The reported MAE of the subject device (1.88 mm) was comparable to the predicate device [1.95 mm (95% CI: 1.59 mm, 2.32 mm)].) | |
| Secondary Endpoint: Bias between ground truth and algorithm output (Mean Difference in Bland-Altman analysis). | 0.1 mm (This indicates "little to no bias between the two measurements," demonstrating the study's secondary endpoint was achieved.) |
2. Sample Size and Data Provenance
- Test Set Sample Size: 212 cases
- Data Provenance: Retrospective, multicenter study. Cases were collected from 6 US-based clinical sites, including both academic and community centers. The cases were distinct in time and/or center from those used to train the algorithm.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Three (3)
- Qualifications: US board-certified radiologists.
4. Adjudication Method for the Test Set
The document states the ground truth was "determined by three US board-certified radiologists." While it doesn't explicitly detail a 2+1 or 3+1 method, the implication of "determined by" three experts suggests a consensus-based approach, likely one where all three agreed or a majority agreement was required for the final ground truth. It does not mention any specific adjudication process explicitly (e.g., if disagreements were resolved by a fourth reader).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The study described is a standalone (algorithm-only) performance evaluation against expert-established ground truth. It does not compare human readers with and without AI assistance.
- Effect size of improvement: Not applicable, as no MRMC study was performed.
6. Standalone (Algorithm-Only) Performance
- Was a standalone performance study done? Yes. The "Pivotal Study Summary" describes the evaluation of "the software's performance ... compared to the ground truth," focusing on the algorithm's accuracy in measurement against expert consensus.
7. Type of Ground Truth Used
- Type of Ground Truth: Expert consensus. Specifically, the ground truth was "determined by three US board-certified radiologists."
8. Sample Size for the Training Set
The document explicitly states: "The cases collected for the pivotal dataset were all distinct in time and/or center from the cases used to train the algorithm." However, the exact sample size for the training set is not provided in the given text.
9. How the Ground Truth for the Training Set was Established
The document does not detail how the ground truth for the training set was established. It only mentions that the training cases were distinct from the test set cases.
§ 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).