(262 days)
Open Rib is image analysis software for chest CT images. Open Rib offers a visualization of the unfolded rib cage that allows a physician to instantly view the full rib anatomy and should be used as an additional view in adjunct to conventional multiplanar reformat views. Open Rib offers geometric and HU measurement tools.
Open Rib is image analysis software for chest CT images. The software resides on the Vitrea Advanced Visualization (AV) platform.
Open Rib offers a visualization of the unfolded rib cage called an "unfolded cylindrical projection" (UCP) that allows a physician to instantly view the full rib anatomy and should be used as an additional view in adjunct to conventual multiplanar reformat views. Open Rib offers geometric and HU measurement tools.
The images can be directly exported to PACS and batch saved.
Here's a breakdown of the acceptance criteria and the study details for the Open Rib device, based on the provided FDA 510(k) summary:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Visualization of Unfolded Rib Cage: The device must successfully generate unfolded cylindrical projections of the ribs that are an adjunct to conventional MPR views, and be deemed clinically useful and effective by evaluators. | All three radiologist readers responded "yes" to all questions regarding the clinical utility and effectiveness of the unfolded rib view, measurement tools, and overall application/workflow. This indicated the device met pass criteria for visualization of the rib cage and successfully generates unfolded cylindrical projections of the ribs that are an adjunct to a conventional MPR view. |
| Measurement Tools Functionality: The geometric and HU measurement tools must be functional and considered clinically useful. | All three radiologist readers responded "yes" to all questions regarding the clinical utility and effectiveness of the measurement tools. |
| Overall Application and Workflow: The Open Rib application and its workflow must be considered clinically useful and effective. | All three radiologist readers responded "yes" to all questions regarding the clinical utility and effectiveness of the overall application and workflow. |
| Software Verification and Validation: Software functions must remain consistent with software requirements and achieve all product release criteria. | Software verification and validation activities were completed, and the Open Rib software achieved all product release criteria. |
2. Sample Size and Data Provenance
- Test Set Sample Size: 30 chest CT cases.
- Data Provenance: The cases were acquired with various CT scanners from different manufacturers (Canon: 17, Siemens: 8, GE: 4, Philips: 1). The country of origin for the data is not explicitly stated, but the study evaluators were U.S. board-certified radiologists, implying the study was conducted in the US. The data appears to be retrospective, as it refers to "datasets included" rather than prospectively acquired data for the study.
3. Number of Experts and Qualifications
- Number of Experts: 3.
- Qualifications of Experts: U.S. board-certified radiologists. No specific years of experience are provided, but board certification implies a certain level of expertise.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated as a formal adjudication method. Instead, each evaluator (radiologist) reviewed 10 cases, with cases evenly distributed among them. They were then presented with a list of questions about clinical utility and effectiveness. A "pass" result required positive answers to all questions from all three readers. This suggests a consensus-based evaluation where all experts had to agree on the positive assessment for the device to pass. There was no explicit mention of an adjudicator to resolve disagreements, as "positive answers to all questions" from all three was the criterion.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not performed. The study focused on the standalone performance and perceived utility of the Open Rib visualization and tools when used as an adjunct to conventional views. It did not quantify an improvement in human reader performance directly attributable to the AI.
6. Standalone Performance (Algorithm Only)
- Standalone Performance: Yes, the study essentially describes a standalone performance evaluation of the "Open Rib" software. The evaluators were assessing the generated unfolded rib views and measurement tools themselves. While radiologists were "using" the device, their evaluation was of the output of the algorithm (the UCP view) and its utility, not a comparison of their diagnostic accuracy with and without the device. The prompt asks for "algorithm only without human-in-the loop performance," and while radiologists were in the loop for evaluation, the core function being assessed was the software's ability to generate the UCP view and its perceived utility. The "pass" criteria rely on the radiologists' positive assessment of the device's output.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the presence or absence of abnormalities (e.g., normal vs. abnormal cases like rib fractures, bony lesions, kyphosis) was likely established by the referring physician's diagnosis, prior imaging reports, or a consensus of experts prior to the study, as cases were selected to include both normal (12 cases) and abnormal (18 cases) findings. However, the evaluation for device performance was based on expert consensus (radiologist assessment) of the clinical utility and effectiveness of the device's output (the UCP view, measurement tools, and workflow).
8. Sample Size for the Training Set
- Training Set Sample Size: Not provided in the document. The document describes the validation/test set but does not mention the size or characteristics of any training data used to develop the Open Rib algorithm.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not provided. Since the training set size is not mentioned, how its ground truth was established is also not detailed in this section of the 510(k) summary.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.