(229 days)
EFAI Intelligent Cardiothoracic Ratio Assessment System (or iCTR) is a software for use by hospital and clinics to automatically assess the cardiothoracic ratio (CTR) of a chest X-ray image from the X-ray imager subject. The iCTR is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR of a chest X-ray image in posterior (PA) chest view using an artificial intelligence algorithm.
Intended users of the software are aimed to the physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services. The system is suitable for adults between 20 - 80 years of age.
Its results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of cardiothoracic ratio (CTR) cases.
The iCTR 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 CTR through an artificial intelligence algorithm. The structure 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, and the trajectory of CTR records. The trajectory of CTR does not implement a predictive or prognostic feature.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
Device Name: EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly present a formal "acceptance criteria" table with thresholds. Instead, it describes performance metrics that were achieved and deemed "met" or "greater than" a certain level. For clarity, I've inferenced the acceptance criteria based on these reported performance numbers.
| Feature / Metric | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Accuracy - Identification of Imaging Mode | > 95% | 0.99 (99%) |
| Accuracy - Identification of View | > 95% | 0.99 (99%) |
| Quality Control Model: Filter non-CXR images | Sensitivity > X, Accuracy > Y (e.g., deemed sufficient by FDA) | Sensitivity: 0.99, Accuracy: 0.99 |
| Quality Control Model: Filter non-PA view CXR | Sensitivity > X, Accuracy > Y (e.g., deemed sufficient by FDA) | Sensitivity: 0.99, Accuracy: 0.97 |
| Boundary Clarity Threshold Message | Present message for unclear images whose threshold |
§ 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).