(77 days)
AVIEW CAC provides quantitative analysis of calcified plaques in the coronary arteries using non-contrast/non-gated Chest CT scans. It enables the calculation of the Agatston score for coronary artery calcification, segmenting and evaluating the right coronary artery and left coronary artery. Also provide risk stratification based on calcium score, gender, and age, offering percentile-based risk categories by established guidelines. Designed for healthcare professionals, including radiologists and cardiologists, AVIEW CAC supports storing, transferring, inquiring, and displaying CT data sets on-premises, facilitating access through mobile devices and Chrome browsers. AVIEW CAC analyzes existing non-contrast/non-gated Chest CT studies that include the heart of adult patients above the age of 40. Also, the device's use should be limited to CT scans acquired on General Electric (GE) or its subsidiaries (e.g., GE Healthcare) equipment. Use of the device with CT scans from other manufacturers has not been validated or recommended.
The AVIEW CAC is a software product that can be installed on a PC. It shows images taken with the interface from various storage devices using DICOM 3.0, the digital image and communication standard in medicine. It also offers functions such as reading, manipulation, analyzing, post-processing, saving, and sending images by using software tools. And is intended for use as a quantitative analysis of CT scanning. It also provides a calcium score by automatically analyzing coronary arteries from the segmented arteries.
The provided text indicates that the device, AVIEW CAC, calculates the Agatston score for coronary artery calcification from non-contrast/non-gated Chest CT scans. It segments and evaluates the right and left coronary arteries and provides risk stratification based on calcium score, gender, and age, using percentile-based risk categories by established guidelines. The device is for healthcare professionals (radiologists and cardiologists) and analyzes existing CT studies from adult patients over 40 years old, acquired on GE equipment.
The document states that a clinical study was not considered necessary and that non-clinical testing supports the substantial equivalence of the device to its predicate. However, it does not provide specific acceptance criteria or an explicit study description with performance metrics for the AVIEW CAC device. It states that the device is substantially equivalent to a predicate device (K233211, also named AVIEW CAC) and that the substantial equivalence is supported by non-clinical testing.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment are not present in the provided text.
Based on the available information:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria or report specific device performance metrics in a tabular format. It generally states that "the results of the software verification and validation tests concluded that the proposed device is substantially equivalent" and "the nonclinical tests demonstrate that the device is safe and effective."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
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 is not mentioned in the document. The document explicitly states: "This Medical device is not new; therefore, a clinical study was not considered necessary prior to release. Additionally, there was no clinical testing required to support the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document implies that the "nonclinical tests" evaluated the device's performance, which would typically involve standalone algorithm performance. However, specific details about such a study or its results are not provided. The device's function is centered on automatic analysis (calculation of Agatston score, segmenting and evaluating arteries).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided in the document.
8. The sample size for the training set:
This information is not provided in the document.
9. How the ground truth for the training set was established:
This information is not provided in the document.
§ 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).