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Rapid Aortic Measurements (AM) is an image analysis and measurement device to evaluate aortic and iliac arteries in contrast enhanced and non-contrast CT imaging datasets acquired of the chest, abdomen, and/or pelvis. The module segments the aorta, iliacs, and major branching vessels and provides 2D and 3D visualizations of the segmented vessels.

Outputs of the device include: Centerline measurements of the aorta and iliacs, Aortic Zone Measurements (Maximum Oblique Diameter), Fixed Measurements of the aorta and left and right iliacs, 3D Volume Renderings, Rotations, Curved Planar Reformations (CPRs) of the isolated left and right iliacs, aortic oblique Multiplanar Reconstructions (MPRs), and Longitudinal Tracking visualizations.

Rapid Aortic Measurements is an aid to physician decision making. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment.

Rapid Aortic Measurements is indicated for adults.

Precautions/Exclusions:

• Series containing excessive patient motion or metal implants may impact module output quality.
• The AM module will not process series that meet the following module exclusion criteria:
  • Series acquired w/cone-beam CT scanners (c-arm CT)
  • Series that are non-axial or axial oblique greater than 5 degrees
  • Series containing improperly ordered or missing slices where the gap is larger than 3 times the median inter-slice distance (e.g., as a result of manual correction by an imaging technician)
  • Series with less than 3cm of target anatomical zones (e.g. aorta or right/left iliac artery)
  • NCCT, CECT, CTA, or CTPA datasets with:
    1. in-plane X and Y FOV < 160mm
    2. Z FOV (cranio-caudal transverse anatomical coverage) < 144 mm.
    3. in-plane pixel spacing (X & Y resolution) < 0.3 mm or > 1.0 mm.
    4. inter-slice distance of < 0.3 mm or > 3 mm.
    5. slice thickness > 3 mm.
    6. data acquired at x-ray tube voltage < 70kVp or > 150kVp, including single energy, dual energy, or virtual monochromatic datasets

Rapid Aortic Measurements (AM) is a Software as a Medical Device (SaMD) image processing module and is part of the Rapid Platform. It provides analysis of chest, abdomen, and pelvis non-contrast CT (NCCT), contrast enhanced (CT, CTP (CT- Pulmonary Angiogram, and CTA (CT-Angiography)) for the reconstructed 3D visualization and measurement of arteries from the aortic root to the iliac arteries.

Rapid AM is integrated into the Rapid Platform which provides common functions and services to support image processing modules such as DICOM filtering and job and interface management along with external facing cyber security controls. The Integrated Module and Platform can be installed on-premises within customer's infrastructure behind their firewall or in a hybrid on-premises/cloud configuration. The Rapid Platform accepts DICOM images and, upon processing, returns the processed DICOM images to the source imaging modality or PACS.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for "Rapid Aortic Measurements":

Acceptance Criteria and Device Performance

Study Details:

1. Sample Sizes and Data Provenance:

• Test Set Sample Size: 108 cases from 115 unique patients.
• Data Provenance:
  • Country of Origin: 54 US, 24 OUS (Outside US), 30 unknown.
  • Retrospective/Prospective: Not explicitly stated, but the description "data used during model training" and "test dataset was independent" suggests a retrospective approach.

2. Number of Experts and Qualifications for Ground Truth (Test Set):

• Number of Experts: Up to three clinical experts (for segmentation quality/clinical accuracy). The number of experts involved in establishing ground truth for quantitative segmentation and measurement accuracy metrics is not explicitly stated but implies expert involvement.
• Qualifications of Experts: Not explicitly stated beyond "clinical experts."

3. Adjudication Method (Test Set):

• Adjudication Method: "Consensus of up to three clinical experts" for the segmentation quality/clinical accuracy endpoint. For other endpoints where "agreement between readers" is mentioned, it implies a consensus or agreement-based adjudication. No specific scheme like "2+1" or "3+1" is detailed.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was it done? No, an MRMC comparative effectiveness study was not explicitly mentioned. The FDA letter describes standalone device performance against ground truth and expert consensus.
• Effect Size of Human Readers with/without AI: Not applicable, as an MRMC study was not conducted or reported.

5. Standalone Performance Study:

• Was it done? Yes, both a "Segmentation Quality Study" and a "Segmentation Accuracy Study" were conducted to assess the algorithm's standalone performance. The results reported in the table above are from these standalone evaluations.

6. Type of Ground Truth Used:

• Ground Truth Type:
  • Expert Consensus: Used for segmentation quality and clinical accuracy, determined by the "consensus of up to three clinical experts against the source DICOM images."
  • Approved Ground Truth Segmentations: For measurement reports, AM measurements were compared to "measurements taken from approved ground truth segmentations using a validated technique." This implies expert-derived and validated segmentations serve as the reference for measurements.

7. Sample Size for Training Set:

• Training Set Sample Size: Not explicitly stated. The document mentions "The test dataset was independent from the data used during model training," but does not provide details on the size of the training dataset itself.

8. How the Ground Truth for the Training Set was Established:

• How Ground Truth Established: Not explicitly stated in the provided text. The document only mentions that the test dataset was independent from the training data.

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