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Cardiac Function Analysis: The Cardiac Function Analysis software option for use with Ziostation is intended for noninvasive post-processing of DICOM compliant cardiac CT images to semi-automatically calculate and display various functional parameters, such as left ventricular ejection fraction, end diastolic volume, end systolic volume, stroke volume, cardiac output, cardiac index, wall thickness, wall thickness ratio and regional wall motion display. These measurements can be used to assist the clinician in a cardiac evaluation.

Calcium Scoring: The Calcium Scoring software option for use with Ziostation is a non-invasive post processing software tool that can be used with CT images to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease.

Cardiac Function Analysis and Calcium Scoring are add-on software packages designed to be used with the basic Ziostation image management system to further aid clinicians in their analysis of anatomy and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation software. The additional capabilities provided by these two new devices are:

Cardiac Function Analysis software post-processes ECG-gated cardiac CT images and extracts the following left ventricular parameters from multi-phase data.

• Left ventricular ejection fraction
• End diastolic volume
• End systolic volume
• Stroke volume
• Cardiac output
• Cardiac Index
• Wall thickness
• Wall thickness ratio
• Wall movement .
• . Volume Curve

Calcium Scoring software post-processes DICOM-based cardiac CT images and evaluates calcified plaque in the coronary arteries, providing the clinician with both Agatston and Volume calcium scores. These regions of interest are selected by the user.

The provided text does not contain detailed acceptance criteria for the "Cardiac Function Analysis" and "Calcium Scoring" software, nor does it describe a specific study proving the device meets acceptance criteria in terms of performance metrics like sensitivity, specificity, or agreement with ground truth.

The document mainly focuses on the regulatory submission process, intended use, device description, and substantial equivalence to predicate devices, rather than detailed performance studies against specific acceptance criteria.

Therefore, many of the requested sections cannot be filled from the given text.

Here's what can be extracted based on the provided information:

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

No explicit acceptance criteria (e.g., minimum accuracy, sensitivity, or agreement percentages) are stated, and no specific performance metrics are reported in the provided text. The document states "The Cardiac Function Analysis and Calcium Scoring software packages will successfully complete integration testing/verification testing prior to Beta validation. Software Beta testing/validation will be successfully completed prior to release." This indicates that internal testing was conducted, but no results are presented.

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

Not mentioned 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)

Not mentioned in the document.

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

Not mentioned 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

Not mentioned in the document.

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

The "Intended Use" section for both Cardiac Function Analysis and Calcium Scoring states that the software is intended for semi-automatic calculations and is a post-processing software tool where "regions of interest are selected by the user." This implies that the device is not purely standalone but is designed to assist a human user (human-in-the-loop). However, no standalone performance study results are provided.

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

Not mentioned in the document.

8. The sample size for the training set

Not mentioned in the document.

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

Not mentioned in the document.

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