(29 days)
The COR Analyzer II is intended to assist a trained physician to analyze Computed Tomography (CT) Angiographic images. The device is not intended for use with mammography. The COR Analyzer II is specifically indicated to provide visualization of the major coronary vessels and lesions, thus assisting the physician in visualizing the coronary anatomy and pathology. COR Analyzer II has abilities for coronary vessels segmentations, abnormalities display and processing.
COR Analyzer I is a post processing software application which runs on a stand-alone Windows based work-station. The device input is Computed Tomography Angiography (CTA) set of images. The received data is displayed on the workstation screen, reviewed and selected by the operator for processing. Software provides the location and segmentation of the coronary artery tree. The software also labels the coronary arteries and displays them uniquely colored in a 3D view. The artery changes of volumes are processed and deviations from expected values are detected. When a deviation exceeds threshold value it is displayed on the 3D view.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. The 510(k) summary (K072242) for COR Analyzer II states that "Bench and clinical data demonstrate that the COR Analyzer II meets the required specifications." However, it does not provide the specific acceptance criteria, performance metrics, study design, or results of those bench and clinical studies.
Therefore, I cannot populate the table or answer most of the questions based on the provided document.
Here's a breakdown of what can be extracted and what is missing:
| Information Requested | Available in Document (Y/N) | Details if available |
|---|---|---|
| 1. Acceptance criteria table and reported performance | N | The document states, "Bench and clinical data demonstrate that the COR Analyzer II meets the required specifications," but does not list the specific specifications (acceptance criteria) or the measured performance values for comparison. |
| 2. Sample size and data provenance (test set) | N | No information on sample size for any test set or the provenance (country, retrospective/prospective) of data used for testing or validation is provided. |
| 3. Number and qualifications of experts (test set GT) | N | No information regarding experts used to establish ground truth for a test set or their qualifications. |
| 4. Adjudication method (test set) | N | No information on adjudication methods. |
| 5. MRMC comparative effectiveness study and effect size | N | The document describes a standalone post-processing software; it does not mention a multi-reader, multi-case (MRMC) comparative effectiveness study, nor does it quantify an effect size for human reader improvement with AI assistance. The device is intended to "assist a trained physician," implying human-in-the-loop, but no study details are provided. |
| 6. Standalone performance study | Y | The device is described as a "post processing software application which runs on a stand-alone Windows based work-station." This implies it operates independently to produce outputs, which are then reviewed by an operator. However, the document does not describe a standalone performance study with specific metrics, just that "Bench and clinical data demonstrate that the COR Analyzer II meets the required specifications." So, while the device is standalone in its operation, the details of a standalone performance study are absent. |
| 7. Type of ground truth used | N | No information on the type of ground truth (e.g., expert consensus, pathology, outcomes data) used for any validation or testing. |
| 8. Sample size for training set | N | No information on the sample size used for training the algorithm (if any machine learning model is involved, which is implied by "segmentation" and "abnormalities display and processing"). |
| 9. How training set ground truth was established | N | No information on how ground truth was established for a training set. |
Conclusion:
The provided 510(k) summary for K072242, COR Analyzer II, briefly mentions that bench and clinical data "demonstrate that the COR Analyzer II meets the required specifications" and that "No adverse effects have been detected." However, it does not elaborate on the specific acceptance criteria, the details of these studies, the methodologies used (like sample sizes, ground truth establishment, expert involvement, or adjudication methods), or the actual performance results. This level of detail is typically found in the full 510(k) submission not publicly available here, or in supporting documentation that would accompany such a summary for a reviewer.
§ 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).