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This software displays medical images and associated documents. With appropriate display monitors, lighting, image quality, and level of lossy image compression, the software is intended for use as a primary diagnostic (on desktop platform) and non-diagnostic review tool (on mobile platform) for use by trained healthcare professionals. Each healthcare professional must determine if the level of loss is acceptable for their purpose. This software is not suitable for primary diagnosis of mammograms.

RapidResults is a cutting edge application that provides of interactivity while maintaining the ease of use and security you've come to expect from RamSoft. Patient images and reports are available to view with zero footprint as there is no need to download special software. With RapidResults, the software allows users to perform image manipulations, including windowlevel, rotation, flip, zoom, panning, hanging protocol layout, measurement, localizer line, and study linking.

Available on popular mobile and desktop platforms with keyboard, mouse, and touch inputs, RapidResults provides access to medical images and associated documents in a convenient way for health care professionals to use as primary diagnostic and review tools.

RapidResults supports major desktop and mobile browsers such as Internet Explorer 10.0 or higher, Chrome, and Safari, Apple iOS, Android, Windows Mobile. It has been extensively tested with iOS (iPad Retina, iPad 2, and iPhone), Android (Galaxy Tab Pro, Galaxy Notes), Windows Mobile (Dell Latitude 10-ST2 Windows 8 Pro Tablet).

The provided text describes a 510(k) premarket notification for the device "RapidResults" by RamSoft, Inc. The document aims to demonstrate substantial equivalence to a predicate device, focusing on its intended use as a medical image display and review tool.

However, the provided text does not contain detailed information about specific acceptance criteria, a study proving the device meets those criteria, or the methodology of such a study. The document primarily focuses on establishing substantial equivalence to a predicate device (Centricity Universal Viewer Zero Footprint client, K131977) by comparing general characteristics and intended uses.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies based solely on the provided text.

The closest information related to "performance" is a general description of the device's functionality and a comparison of features with the predicate device, but not quantitative performance against pre-defined acceptance criteria.

Key points from the document that are relevant to the requested categories (but lack the specific details you're looking for):

• Device Name: RapidResults
• Intended Use: Primary diagnostic (on desktop platform) and non-diagnostic review tool (on mobile platform) for medical images and associated documents. Not suitable for primary diagnosis of mammograms.
• Predicate Device: Centricity Universal Viewer Zero Footprint client (ZFP) - K131977
• Testing Mentioned: "It has been extensively tested with iOS (iPad Retina, iPad 2, and iPhone), Android (Galaxy Tab Pro, Galaxy Notes), Windows Mobile (Dell Latitude 10-ST2 Windows 8 Pro Tablet)." This refers to compatibility testing, not a clinical performance study.
• HIPAA Compliance: The viewer "secured connects to the PACS using HTTPS" and "Images stay in the PACS, not on the device."

To answer your request, I would need a different type of document, such as a detailed design validation report or a clinical study report, which would typically be submitted as part of the 510(k) submission but are not included in this summary.

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