(154 days)
qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans.
qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm.
The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities.
The system is suitable for adults > 22 years of age.
The device is used to aid the intended users and results are not intended to be used on a stand-alone basis for clinical decision making or otherwise preclude clinical assessment of CTR cases.
The qXR-CTR is a non-invasive software medical device designed to be installed on the computer with specific system requirements. It is a radiological computer-assisted software system that automatically analyzes DICOM chest X-ray images in PA view and outputs the cardiac diameter, thoracic diameter, and CTR through an artificial intelligence algorithm. The structured report includes a preview of the compressed chest X-ray image with the automatically derived CTR result and annotation line, indicating the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity.
Acceptance Criteria and Study Details for qXR-CTR
1. Table of Acceptance Criteria and Reported Device Performance
| Measure | Acceptance Criteria (Predicate) | Reported Device Performance (qXR-CTR) |
|---|---|---|
| Cardiac Diameter RMSE | 8.81 mm | 7.55 (6.95, 8.34) mm |
| Thoracic Diameter RMSE | 14.4 mm | 5.43 (4.95, 6.11) mm |
| Cardiac Diameter MAE | Not Reported | 5.66 (5.0) mm |
| Thoracic Diameter MAE | Not Reported | 4.04 (3.63) mm |
| CTR | 0.03 (0.02, 0.03) | 0.02 (0.02) |
2. Sample Size and Data Provenance for Test Set
- Sample Size: 435 scans.
- Data Provenance: Retrospectively collected chest X-rays from various parts of the US.
3. Number and Qualifications of Experts for Ground Truth (Test Set)
- Number of Experts: 3
- Qualifications: ABR (American Board of Radiology) thoracic radiologists with a minimum of 10 years of experience.
4. Adjudication Method for Test Set
The adjudication method is not explicitly stated, but with 3 experts establishing ground truth, a consensus method (e.g., majority vote or discussion to agreement) is implied. It's not explicitly stated as 2+1, 3+1, or none.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The document describes a standalone performance evaluation of the qXR-CTR against ground truth established by experts.
6. Standalone Performance
Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The reported performance metrics (RMSE, MAE) are intrinsic to the device's measurements compared to expert-established ground truth.
7. Type of Ground Truth Used
Expert consensus. The ground truth was established by three ABR thoracic radiologists.
8. Sample Size for Training Set
The sample size for the training set is not provided in the given text.
9. How Ground Truth for Training Set was Established
The method for establishing ground truth for the training set is not described in the provided text.
§ 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).