(439 days)
iCAD's VeraLook™ CTC CAD is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
The VeraLook is a software-based CAD system for detecting the location and extent of polyps in CTC exams. The product is intended to receive CTC images in standard DICOM format from any 3D workstation manufacturer, perform automated analysis on the images to identify polyps, and then produce information about the identified regions that can be received and displayed by CTC review workstations to help radiologists in the detection of polyps.
This looks like a medical device submission, specifically a 510(k) summary for iCAD's VeraLook™ CTC CAD Software. The provided text doesn't contain a detailed study report with specific acceptance criteria and performance metrics. Instead, it offers a high-level overview of the device, its intended use, and a general statement about clinical data being supplied to satisfy the FDA's requirements.
Therefore, I cannot populate all the requested information directly from the provided text. I can only extract what is explicitly stated or can be reasonably inferred. Many of the requested details (like sample sizes, number of experts, adjudication methods, ground truth types for training and testing, and specific performance metrics) are not present in this summary document.
Here's a response based on the available information:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The provided 510(k) summary states that "iCAD has supplied clinical data in addition to bench testing and simulations to assess safety and effectiveness of this claim" (referring to the claim of identifying "additional potential polyps that may not have been identified on initial review"). However, the summary does not provide specific acceptance criteria or the detailed results of that study.
Based on the provided text, the specific acceptance criteria and the detailed study proving the device meets them are not described. The summary only mentions that clinical data was supplied to address potential safety and effectiveness issues related to the device's specific claim.
1. Table of Acceptance Criteria and Reported Device Performance
Cannot be fully populated from the provided text. The document does not list specific acceptance criteria (e.g., sensitivity, specificity thresholds) nor does it provide a table of reported device performance metrics against such criteria.
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Specific Acceptance Criteria | (Not explicitly stated in the provided text) | (Not explicitly stated in the provided text) |
| Device Performance (e.g., Sensitivity, Specificity) | (Not explicitly stated in the provided text) | (Not explicitly stated in the provided text) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only generally states that "clinical data was supplied."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The provided text does not specify the number of experts used or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
The provided text does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
The provided text does not explicitly state whether an MRMC comparative effectiveness study was done. It mentions the intent to identify "additional potential polyps that may not have been identified on initial review," which suggests an assist-read paradigm, but the details of such a study are not included. Therefore, the effect size of human readers' improvement with AI vs. without AI assistance is not provided.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The provided text does not explicitly state whether a standalone (algorithm only) performance study was done. The indication for use describes the device as providing "highlighted" polyps "after initial review of the CTC exam," implying human-in-the-loop performance.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The provided text does not specify the type of ground truth used for either the test set or the training set.
8. The Sample Size for the Training Set
The provided text does not specify the sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
The provided text does not describe how the ground truth for the training set was established.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.