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The Prowin™ software program is a Windows-based application used on a personal computer intended for viewing carotid ultrasound images and measuring arterial wall thickness. It is specifically indicated for the measurement of carotid artery far and near wall intima-media thickness (IMT) from images obtained from an ultrasound system. A physician may use this information in conjunction with other medical data in the assessment of a patient's cardiovascular risk.

Prowin™ is a software program designed to measure carotid artery intimamedia thickness from ultrasound images. Prowin™ operates on a stand-alone personal computer running a Microsoft Windows™ operating system. Carotid artery images from any ultrasound machine are transferred to the computer running Prowin™ by way of any media. Following the transfer of images, Prowin™ uses proprietary, patent-pending algorithms to measure intima-media thickness (IMT) of the near and far walls of the carotid artery. The Prowin™ software also has the capability to generate a report indicating the IMT value.

Here's a breakdown of the acceptance criteria and study information for K050376, Prowin™ Medical Image Measurement Software, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state acceptance criteria in terms of performance metrics (e.g., minimum accuracy, maximum deviation). Instead, it focuses on demonstrating measurement repeatability as an indicator of performance.

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