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510(k) Data Aggregation
(21 days)
RCADIA MEDICAL IMAGING LTD.
The COR Analyzer 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 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 has abilities for coronary vessels segmentations, abnormalities display and processing.
The COR Analyzer (unmodified) device is a post processing software application which runs on a standalone server, work-station. The device input is Computed Tomography (CTA) set of images. The Device Software provides the location and segmentation of the (RCA, LM, LAD & LCX) coronary arteries. The software also labels these arteries and displays them uniquely colored in a 3D view. 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 device has been modified to include also the location, segmentation & processing of major branches (of the RCA, LM, LAD & LCX) arteries. The device reliability & user interface have been modified to improve convenience of use.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. It states that "Its performance has been validated by comparison the processing results to experienced radiologists' interpretation of the same data and to the processing results of the predicate device." However, it does not elaborate on the specifics of this validation study.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 based on the given information. The document is a 510(k) summary, which typically provides a high-level overview. Detailed study results and acceptance criteria are usually found in the full 510(k) submission, which is not provided here.
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(29 days)
RCADIA MEDICAL IMAGING LTD.
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.
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(59 days)
RCADIA MEDICAL IMAGING LTD.
The COR Analyzer I is intended to assist a trained physician to analyze Computed Tomography (CT) Angiographic images. The COR Analyzer I 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 I 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. The application enables interactive user-software process in which the user chooses a CT slice, points on the selected coronary vessel and the software present the entire selected vessel as a stretched image. In a reversed process, the user can mark a specific point on the stretched vessel and the software retrieves and displays the original correspondent CT slice. COR Analyzer I output results can be stored for future analysis.
The provided text does not contain detailed acceptance criteria and the results of a study proving the device meets those criteria. The 510(k) summary states generally that "Bench and clinical data demonstrate that the COR Analyzer I meets the required specifications," but it does not specify what those specifications are, nor does it provide details about the clinical data.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed information about a study based on the provided text.
Here's an explanation of why the requested information cannot be generated from the given text:
- Acceptance Criteria Table and Performance: The document states, "Bench and clinical data demonstrate that the COR Analyzer I meets the required specifications." However, it does not define what those "required specifications" are (e.g., sensitivity, specificity, accuracy thresholds for specific tasks like lesion detection or vessel segmentation). Without these explicit criteria, a table cannot be created.
- Sample Size and Data Provenance: No information is provided regarding the number of cases or studies used, whether the data was retrospective or prospective, or the country of origin.
- Number of Experts and Qualifications: There is no mention of experts, how many were used, or their qualifications (e.g., radiologists, cardiologists, experience level).
- Adjudication Method: No adjudication method (e.g., 2+1, 3+1) is described.
- MRMC Comparative Effectiveness Study: The document does not describe any multi-reader multi-case study comparing human readers with AI assistance versus without. Therefore, an effect size cannot be determined or reported.
- Standalone Performance: While the device is a "post processing software application," the text doesn't explicitly state results from a standalone performance study. It mentions the application enables "interactive user-software process," suggesting a human-in-the-loop design without presenting separate standalone algorithm performance statistics.
- Type of Ground Truth: The document does not specify how ground truth was established for any claimed "clinical data." Options like expert consensus, pathology, or outcomes data are not mentioned.
- Training Set Sample Size and Ground Truth: There is no information provided about a training set, its size, or how its ground truth was established. The document focuses on regulatory submission and device description rather than a detailed study report.
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