(29 days)
cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC).
cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also marks BAC segments on thumbnails of images for localization of BAC.
The software is intended to be used by qualified interpreting physicians in parallel with breast screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection. The device results should not be used alone to make any diagnosis and/or treatment decisions.
Not Found
The provided FDA 510(k) Clearance Letter for cmAngio® (V1.6) does not contain the detailed information required to answer most of your questions about the acceptance criteria and the study that proves the device meets them. This document is primarily a clearance letter, indicating that the device has been deemed substantially equivalent to a predicate device and outlining regulatory obligations. It does not typically include the specifics of performance studies.
However, based on the information that is available, here's what can be extracted:
Indications for Use:
cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC). It is an AI-based software intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC) in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also marks BAC segments on thumbnails of images for localization. It is to be used by qualified interpreting physicians in parallel with breast screening mammography workflow and is not intended for primary interpretation or for making diagnosis/treatment decisions alone.
Given the typical content of a 510(k) clearance letter versus a full submission, the following information is not present in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set.
- Data provenance for the test set.
- Number of experts used to establish ground truth for the test set.
- Qualifications of those experts.
- Adjudication method for the test set.
- Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done.
- The effect size of human readers improving with AI vs. without AI assistance.
- Whether a standalone (algorithm-only) performance study was done.
- The type of ground truth used (e.g., pathology, outcomes data).
- The sample size for the training set.
- How the ground truth for the training set was established.
To obtain this information, one would typically need access to the full 510(k) submission document, which includes the detailed clinical and technical performance studies. The clearance letter only summarizes the outcome of the FDA's review.
§ 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).