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QCA-CMS provides quantitative and reproducible information regarding the calculated dimensions of arterial segments imaged during angiographic x-ray procedures typically performed in cardiac cath labs. This information is suitable for use by physicians and scientists in the following applications:

1. Scientific and research studies, assessing the angiographic condition of patients and the results of device and drug therapies,

2. Review and analysis of patient angiographic imaging records, providing additional information to physicians and administrators.

QCA-CMS performs quantitative analysis of angiograms that are input to the system in formats that include digitized video (from 35 mm cinefilm) and DICOM-file standard formats. The analysis results of the QCA-CMS operation may be printed or archived in files for export to a general-purpose database.

The provided document does not contain an acceptance criteria table, a study that proves the device meets specific acceptance criteria, or information regarding the device's performance metrics (e.g., accuracy, sensitivity, specificity).

The document is a 510(k) summary for a software device called QCA-CMS, which performs quantitative analysis of coronary angiograms. It focuses on demonstrating substantial equivalence to a predicate device (Cardiovascular Measurement System - CMS) and describes the intended use and technological characteristics.

Therefore, I cannot provide the requested information based on the input document.

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