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510(k) Data Aggregation
(51 days)
vascuCAP is a medical image analysis system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired with contrast from CT imaging devices.
vascuCAP is intended to assist trained physicians in the stratification of patients identified to have atherosclerosis. The software post processes images obtained using a multidetector CT. The package provides tools for the measurement and visualization (color coded maps) of arterial vessels.
Clinicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross-sectional measurements can be obtained using standard vascuCAP software measuring tools. Clinicians can semi-automatically determine contrasted lumen boundaries, stenosis measurements, and maximum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Hounsfield unit or signal intensity statistics. Clinicians can also manually measure vessel length along the centerline in standard curved MPR views.
The measurements provided by vascuCAP are not intended to provide a diagnosis or clinical recommendations. vascuCAP is intended as a tool to complement standard of care.
vascuCAP is an image analysis software package for evaluating CT images of arterial vessels. It allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from CT scanners. vascuCAP provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and tissue characteristics. The vascuCAP software application user interface follows typical clinical workflow patterns to process, review, and analyze digital images.
The provided text describes the performance data for the vascuCAP A.1.2 device, comparing it to a predicate device. Here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as pass/fail thresholds against which the device was evaluated. Instead, it presents "analytic performance metrics" as established results from the testing. For each metric, the reported performance includes bias, intercept, slope, quadratic term, and R^2, along with 95% confidence intervals. The "tested range" indicates the range of true values for the measurand.
Table: Reported Device Performance Metrics (Implicit Acceptance Criteria)
| Structure/Composition | Measurand (Tested Range) | Reported Performance (Point Estimate [95% Confidence Interval]) |
|---|---|---|
| Structure | Lumen Area (0.3 - 290.1mm²) | Bias: 0.81mm² [0.3, 1.9], Intercept: 0.65mm² [-0.6, 0.9], Slope: 1.01 [0.9, 1.0], Quadratic term: 0.0 [0.0, 0.0], R²: 0.9987 |
| Wall Area (9.4 - 448.6mm²) | Bias: 0.50mm² [-1.08, 1.29], Intercept: -0.59mm² [-4.1, 2. 8.0], Slope: 1.0 [0.99, 1.04], Quadratic term: 0.0 [0.0, 0.0], R²: 0.9974 | |
| Stenosis** (33-69%) | Vessels ≥5.9mm: Bias: 3.7% [1.29, 4.47], Intercept: 5.99% [-0.81, 9.93], Slope: 0.96 [0.84, 1.1], Quadratic term: -0.01 [-0.02, 0.01], R²: 0.8034 Vessels <5.9mm: Bias: 9.3% [2.14, 12.72], Intercept: 34.0% [-2.3, 38.9], Slope: 0.55 [0.42, 1.21], Quadratic term: 0.001 [-0.02, 0.06], R²: 0.9549 | |
| Wall Thickness (1.0 - 9.0mm) | Bias: 0.5mm [0.3, 0.6], Intercept: 0.27mm [-0.1, 0.5], Slope: 1.05 [1.01, 1.1], Quadratic term: -0.008 [-0.02, 0.01], R²: 0.9855 | |
| Plaque Burden (0.4 -1.0 ratio) | Bias: -0.01 [-0.01, .004], Intercept: 0.01 [-0.1, 0.04], Slope: 0.99 [0.9, 1.1], Quadratic term: 0.03 [-0.1, 0.3], R²: 0.9794 | |
| Composition | Calcified Area (0.0 - 51.2mm²) | Difference: 0.15mm² [-0.5, 0.97], Intercept: 0.4mm² [-0.02, 1.6], Slope: 0.9 [0.6, 1.1], Quadratic term: -0.01 [-0.1, 0.04], R²: 0.875 |
| LRNC Area (0.0 - 26.8mm²) | Difference: 0.8mm² [-0.7, 2.6], Intercept: 1.44mm² [0.2, 3.4], Slope: 0.8 [0.2, 1.1], Quadratic term: 0.004 [-0.1, 0.3], R²: 0.5222 | |
| Matrix Area (2.6 - 57.1mm²) | Difference: -1.6mm² [-3.6, 0.32], Intercept: 2mm² [-3, 5], Slope: 0.83 [0.7, 1.0], Quadratic term: -0.01 [-0.04, 0.01], R²: 0.7469 |
Note on "Acceptance Criteria": The document doesn't define explicit numerical acceptance criteria (e.g., "Bias must be less than X"). Instead, the presentation of these metrics with their 95% confidence intervals implies that the demonstrated performance as reported is considered acceptable for substantial equivalence to the predicate device. The narrative emphasizes "demonstrating that the product meets defined system requirements and features" and "established analytic performance metrics," without listing specific pre-defined thresholds.
2. Sample Size Used for the Test Set and Data Provenance
The document indicates that "Validation testing using phantom and clinical images was conducted."
-
Phantom Data:
- Sample size: Not explicitly stated as a number of phantom images or measurements, but it mentions, "The mean tested phantom vessel size is 8.7mm [3.9mm]."
- Provenance: This is lab-generated data from anthropomorphic phantoms. No country of origin is specified, but it's typically an in-house or contracted lab study.
- Retrospective/Prospective: Phantom studies are inherently prospective, as they are designed experiments.
-
Clinical Image Data:
- Sample size: Not explicitly stated as a number of clinical images/patients.
- Provenance: The document refers to "histopathologic specimens" which were "ex vivo tissue specimens with paired CTA." "The tissue specimens are from the carotid artery." No country of origin is specified.
- Retrospective/Prospective: The use of "ex vivo tissue specimens with paired CTA" and "clinically-accepted scanning protocols" suggests these were likely retrospective collections of clinical images and corresponding tissue samples.
3. Number of Experts and Qualifications for Ground Truth
-
Structural measurements (from phantoms):
- Number of Experts: Not applicable, as ground truth for anthropomorphic phantoms is established using "micrometer measurements."
- Qualifications: "Micrometer measurements on anthropomorphic objects."
-
Composition (tissue types from clinical images):
- Number of Experts:
- Pathologists: Three (3) independent pathologists for histopathology interpretation.
- Radiologists: Two (2) independent radiologist users for aligning annotated sections with 3D radiology volume.
- Qualifications:
- Pathologists: "Board certified pathologists."
- Radiologists: Not explicitly stated, but inferred to be qualified radiologists ("independent radiologist users").
- Number of Experts:
4. Adjudication Method for the Test Set
-
Composition (tissue types):
- Pathologist Agreement: "Three independent annotations were used for these results to account for acknowledged discordance in histopathology interpretation." This implies that the ground truth for pathology was derived from the consensus or agreement among these three pathologists, though the specific adjudication rule (e.g., majority vote, specific expert's decision) is not detailed.
- Radiologist Agreement: "four combinations resulting from two unique positioners crossed with two independent radiologist users were used for these results to account for differences in judgment on where the annotated section data applies within the in vivo volume, blinded to vascuCAP results." Similar to pathologists, this suggests a method to account for variability in radiologist interpretation for ground truthing, though the specific adjudication rule is not provided.
-
Structural measurements (phantom data): Adjudication is not applicable as the ground truth is micrometric measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication of an MRMC comparative effectiveness study that assesses how much human readers improve with AI vs. without AI assistance. The study focuses on the analytical performance of the device's measurements compared to ground truth, not on human reader performance.
6. Standalone Performance
The study primarily describes the standalone (algorithm only without human-in-the-loop performance) of the vascuCAP device. The performance metrics presented (bias, slope, R^2) are direct measures of the algorithm's accuracy against established ground truth for various vascular measurements and compositions.
7. Type of Ground Truth Used
- Structural Measurements (Lumen Area, Wall Area, Wall Thickness, Plaque Burden):
- Phantom Data: Micrometer measurements on anthropomorphic objects.
- Stenosis: Derived from the lumen diameters, with ground truth for lumen diameters from micrometer measurements on phantoms.
- Composition (Calcified Area, LRNC Area, Matrix Area):
- Clinical Data: Expert consensus/interpretation by "board certified pathologists of histopathologic specimens" with paired CT angiogram (CTA) data. This is further refined by "three independent annotations" from pathologists and "four combinations" from two radiologists for positioning. This suggests a multi-expert consensus ground truth for tissue characterization.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set. It focuses on the validation testing performance.
9. How the Ground Truth for the Training Set was Established
Since the training set size is not provided, the method for establishing its ground truth is also not described in this document. The description of ground truth establishment is specifically for the test set used in performance validation.
Ask a specific question about this device
(203 days)
vascuCAP is a medical image analysis system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired with contrast from CT imaging devices.
vascuCAP is intended to assist trained physicians in the stratification of patients identified to have atherosclerosis. The software post processes images obtained using a multidetector CT. The package provides tools for the measurement and visualization (color coded maps) of arterial vessels ≥ 4.5mm in diameter.
Clinicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross-sectional measurements can be obtained using standard vascuCAP software measuring tools. Clinicians can semi-automatically determine contrasted lumen boundaries, stenosis measurements, and maximum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Hounsfield unit or signal intensity statistics. Clinicians can also manually measure vessel length along the centerline in standard curved MPR views.
The measurements provided by vascuCAP are not intended to provide a diagnosis or clinical recommendations. vascuCAP is intended as a tool to complement standard of care.
vascuCAP is an image analysis software package for evaluating CT images of arterial vessels ≥ 4.5mm in diameter. It allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from CT scanners. vascuCAP provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and tissue characteristics. The vascuCAP software application user interface follows typical clinical workflow patterns to process, review, and analyze digital images.
The provided document is a 510(k) premarket notification letter from the FDA to Elucid Bioimaging, Inc. concerning their device, vascuCAP. While it outlines the device's intended use and the general process of software verification and validation, it does not contain specific details regarding acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment methods, or whether MRMC studies were conducted.
The document indicates that software verification and validation were performed consistent with FDA guidance on "General Principles of Software Validation," and that "Validation testing using phantom and clinical images was conducted to address performance qualification of the subject device under typical operating conditions." However, it does not present the results of this validation in a quantitative manner or specify the details requested in your prompt.
Therefore, I cannot extract the information required to populate the table or answer the specific questions about the study design and results from the provided text. The document concludes that "vascuCAP is as safe and effective as the predicate device for the intended use" based on this general testing, but the specifics of how that was demonstrated are not included.
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