(270 days)
AmCAD-UO is a PC-based, self-contained, non-invasive image analysis software application for reviewing the pharyngeal/upper airway ultrasonic image acquired from an FDA-cleared ultrasound system. The software is designed to support visualization and quantification of the airway sonographic characteristics. The software also provides tools for manual or interactive selection of Region of Interest to allow for analysis of the airway in terms of its size, position and enhancement pattern. This analysis provides information for physician's evaluation and monitoring of the airway state.
AmCAD-UO is a PC-based, self-contained, non-invasive image analysis software application for reviewing the pharyngeal/upper airway ultrasonic image acquired from an FDA-cleared ultrasound system. The software is designed to visualization and quantification of the airway sonographic characteristics. The software also provides tools for manual or interactive selection of Region of Interest to allow for analysis of the airway in terms of its size, position and enhancement pattern. This analysis provides information for physician's evaluation and monitoring of the airway state. The generated information by AmCAD-UO software device must not be used alone for primary diagnostic interpretation.
Here's a breakdown of the acceptance criteria and study information for AmCAD-UO based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy of ROI identification and quantification of airspace characteristics | Verified using phantom images under allowable parameter settings. |
| Correlation between AmCAD-UO measurements and MRI measurements (for airway width) | Significant correlation observed; a larger airway width measured by one method was also observed larger by the other. |
| Ability to visualize and quantify airway in terms of size, position, and enhancement pattern | Demonstrated through the study. |
| Software meets all functional and specifications for its indication for use | Confirmed through software unit test, software integration test, and software system test. |
| No direct safety or health risk caused by, or related to, the use of the device | Stated to be confirmed by risk assessment and safety/effectiveness documentation. |
2. Sample size used for the test set and the data provenance:
- Sample Size: "very limited sample size of human subjects." (Specific number not provided)
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The comparison was performed against MRI measurements, implying real human subject data, not synthetic or phantom data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- A MRMC comparative effectiveness study was not mentioned in the document. The study described focused on the device's performance against MRI measurements, not on human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation was done. The study "validated the performance of the AmCAD-UO for its intended use" by comparing its measurements against MRI. The device's output "must not be used alone for primary diagnostic interpretation," implying it's an analysis tool, but its performance was assessed independently as a measurement tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Magnetic Resonance Imaging (MRI) measurements were used as a comparative "ground truth" or reference standard for airway width.
8. The sample size for the training set:
- The document does not specify the sample size for the training set. It only mentions that the software's design is "Based on Statistical Pattern Recognition and Quantification method of airway."
9. How the ground truth for the training set was established:
- The document does not provide details on how the ground truth for the training set was established. It describes the software's methodology as "Statistical Pattern Recognition and Quantification method of airway," which implies a training process, but the specifics of ground truth generation for that training are not mentioned.
§ 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).