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X-RAY VVA is software intended to be used for performing calculations in X-ray angiographic images of the chambers of the heart and of blood vessels. These calculations are based on contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing. X-RAY VVA is also intended to be used for performing caliper measurements. The results obtained are displayed on top of the images and provided in reports. The analysis results obtained with X-RAY VVA are intended for use by cardiologists and radiologists: to support clinical decisions concerning the heart and vessels to support the evaluation of interventions or drug therapy applied for conditions of the heart . and vessels. X-RAY VVA is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the heart and of blood vessels, for use on individual patients with cardiovascular disease. When the quantified results provided by X-RA Y VVA are used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnoiss of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, intefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.

X-RAY VVA (Vessel and Ventricular Analysis) is image post-processing software for the viewing and quantification of digital x-ray angiographic images of blood vessels and of the chambers of the heart. Semi-automatic contour detection forms the basis for the analyses. Its functionality is independent of the type of vendor acquisition equipment. The analysis results are available on screen, and can be exported in various electronic formats. X-RAY VVA has been developed as a standalone application to run on a Windows based operating system. The import of images and the export of analysis results are via CD / DVD, a PACS or network environment. X-RAY VVA has a modular structure that consists of its previously cleared predicate devices: OCA-CMS, QVA-CMS, QLV-CMS, and CMS-VIEW. X-RAY VVA comprises their respective functionalities for analyzing the blood vessels and the left ventricle. In addition, X-RAY VVA includes new functionality for the analysis of: the right ventricle, stent and sub-segments, coronary anewysms, and bifurcations.

The provided text for K112807 does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and study design. The document is a 510(k) summary focusing on substantial equivalence to predicate devices. It states that "Testing and validation have produced results consistent with design input requirements" but does not elaborate on what those requirements or results were.

Therefore, many of the requested fields cannot be accurately filled based on the provided text.

Here's a breakdown of what can and cannot be answered:

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

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

• Sample size for test set: Not specified in the document.
• Data provenance: Not specified 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 specified in the document.

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

• Not specified 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 study is not mentioned in the document. The device is described as "image post-processing software" that assists with quantification, suggesting it's an aid, but no comparative effectiveness study with human readers is described regarding improvement with or without AI assistance.

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

• The document implies that the software's automatic contour detection is presented for review and manual editing, indicating a human-in-the-loop workflow. A standalone performance study of the algorithm alone is not described.

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

• Not specified in the document.

8. The sample size for the training set

• Not specified in the document.

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

• Not specified in the document.

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