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AVIEW CAC provides quantitative analysis of calcified plaques in the coronary arteries using non-contrast/non-gated Chest CT scans. It enables the calculation of the Agatston score for coronary artery calcification, segmenting and evaluating the right coronary artery and left coronary artery. Also provide risk stratification based on calcium score, gender, and age, offering percentile-based risk categories by established guidelines. Designed for healthcare professionals, including radiologists and cardiologists, AVIEW CAC supports storing, transferring, inquiring, and displaying CT data sets on-premises, facilitating access through mobile devices and Chrome browsers. AVIEW CAC analyzes existing non-contrast/non-gated Chest CT studies that include the heart of adult patients above the age of 40. Also, the device's use should be limited to CT scans acquired on General Electric (GE) or its subsidiaries (e.g., GE Healthcare) equipment. Use of the device with CT scans from other manufacturers has not been validated or recommended.

The AVIEW CAC is a software product that can be installed on a PC. It shows images taken with the interface from various storage devices using DICOM 3.0, the digital image and communication standard in medicine. It also offers functions such as reading, manipulation, analyzing, post-processing, saving, and sending images by using software tools. And is intended for use as a quantitative analysis of CT scanning. It also provides a calcium score by automatically analyzing coronary arteries from the segmented arteries.

The provided text indicates that the device, AVIEW CAC, calculates the Agatston score for coronary artery calcification from non-contrast/non-gated Chest CT scans. It segments and evaluates the right and left coronary arteries and provides risk stratification based on calcium score, gender, and age, using percentile-based risk categories by established guidelines. The device is for healthcare professionals (radiologists and cardiologists) and analyzes existing CT studies from adult patients over 40 years old, acquired on GE equipment.

The document states that a clinical study was not considered necessary and that non-clinical testing supports the substantial equivalence of the device to its predicate. However, it does not provide specific acceptance criteria or an explicit study description with performance metrics for the AVIEW CAC device. It states that the device is substantially equivalent to a predicate device (K233211, also named AVIEW CAC) and that the substantial equivalence is supported by non-clinical testing.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment are not present in the provided text.

Based on the available information:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state acceptance criteria or report specific device performance metrics in a tabular format. It generally states that "the results of the software verification and validation tests concluded that the proposed device is substantially equivalent" and "the nonclinical tests demonstrate that the device is safe and effective."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

A MRMC comparative effectiveness study is not mentioned in the document. The document explicitly states: "This Medical device is not new; therefore, a clinical study was not considered necessary prior to release. Additionally, there was no clinical testing required to support the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document implies that the "nonclinical tests" evaluated the device's performance, which would typically involve standalone algorithm performance. However, specific details about such a study or its results are not provided. The device's function is centered on automatic analysis (calculation of Agatston score, segmenting and evaluating arteries).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not provided in the document.

8. The sample size for the training set:

This information is not provided in the document.

9. How the ground truth for the training set was established:

This information is not provided in the document.

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AVIEW CAC provides quantitative analysis of calcified plaques in the coronary arteries using non-contrast non-gated Chest CT scans. It enables the calculation of the Agatston score for coronary artery calcification, segmenting and evaluating the right coronary artery and left coronary artery. Also provide risk stratification based on calcium score, gender, and age, offering percentile-based risk categories by established guidelines. Designed for healthcare professionals, including radiologists and cardiologists, AVIEW CAC supports storing, inquiring, and displaying CT data sets on-premises, facilitating access through mobile devices and Chrome browsers. AVIEW CAC analyzes existing noncontrast/non-gated Chest CT studies that include the heart of adult patients above the age of 40. Also, the device's use should be limited to CT scans acquired on General Electric (GE) or its subsidiaries (e.g., GE Healthcare) equipment. Use of the device with CT scans from other manufacturers has not been validated or recommended.

The AVIEW CAC is a software product that can be installed on a PC. It shows images taken with the interface from various storage devices using DICOM 3.0, the digital image and communication standard in medicine. It also offers functions such as reading, manipulation, analyzing, post-processing, saving, and sending images by using software tools. And is intended for use as a quantitative analysis of CT scanning. It also provides a calcium score by automatically analyzing coronary arteries from the segmented arteries.

The provided text describes the acceptance criteria and the study conducted for the AVIEW CAC device.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the quantitative analysis of calcified plaques is primarily based on the Intraclass Correlation Coefficient (ICC) of the Agatston score against a ground truth and a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • 150 CSCT (gated) cases
  • 150 Chest CT (non-gated) cases
  • Additionally, 280 datasets collected from multiple institutions were used for a separate "MI functionality test report" which also evaluated correlation.
• Data Provenance: The document does not explicitly state the country of origin. The test cases were derived from "multiple institutions". It is implied to be retrospective as the device analyzes "existing" non-contrast/non-gated chest CT studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used or their detailed qualifications (e.g., "radiologist with 10 years of experience") for establishing the ground truth.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (such as 2+1, 3+1) for establishing the ground truth. It simply refers to "ground truth" without detailing its consensus process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on the standalone performance of the algorithm against a defined ground truth and comparison against a predicate device, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The performance data section explicitly states, "we evaluated the agreement in A coronary calcium scoring between the subject device and the ground truth" and "the correlation coefficient A between the AVIEW CAC automatic analysis results of the chest CT based on the heart CT and the Agatston scores was over 90%". This indicates the algorithm's performance without human intervention.

7. The Type of Ground Truth Used

The ground truth used was Agatston scores for coronary artery calcification. The document does not specify if this ground truth was established by expert consensus of human readers, pathology, or outcomes data. However, the comparison is made to "Ground Truth" for Agatston Score measurements, which implies a highly reliable, perhaps manually derived or reference Agatston score.

8. The Sample Size for the Training Set

The document does not provide the sample size for the training set. It only mentions the test set sizes.

9. How the Ground Truth for the Training Set Was Established

The document does not describe how the ground truth for the training set was established. It only refers to deep learning for automatic segmentation but does not detail the process for creating the ground truth data used to train the deep learning model.

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