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InterWorks™ product is intended to provide a completely scalable PACS solution for hospitals and other related sites, which will distribute, retrieve archive, and display, data and images from a variety of different modality and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other Mammo tools. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.

Application areas include imaging centers, radiologist central reading rooms and any other locations where trained medical professionals would require access or desire patient images, demographic information or other patient medical information captured in the system.

Inter Works™ is comprised of software modules that can work together to deliver an integrated solution that provides image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations.

The Image Management module that manages your imaging needs for a Radiology Enterprise. All of the different facets are unified under a single system that acquires, storages, displays and prints medical images. By interVIEW supporting DICOM 3.0 it can Plug-n-Play with other DICOM 3.0 compliant devices with minimal effort. For Practices that are in need of only Tele-Radiology functionality interVIEW TR will meet all the needs.

The Dictation/Transcription module that provides for reliable creation of Radiology reports for your Radiology Enterprise. Reports are created via Voice Recognition with interSCRIBE VR or Digital Dictation with interSCRIBE DD depending upon the individual preferences of the Radiologist and requirements of the Radiology Enterprise. In either case digital files are created by the Radiologist and sent to transcription worklists for transcribing or editing by transcriptionists using interSCRIBE DT. Once the report has been finalized it is electronically signed by the Radiologist and automatically delivered via fax and/or e-mail to referring physicians.

The Radiology Information System module manages your radiology workflow for your Front Desk, Back Office and Clinical operations. All of the different areas of operations are unified under a single system that extends beyond the physical walls to exchange information and perform transactions with important business partners. Most importantly, the rules engine that drives interFLOW can be tailored.

The provided 510(k) summary (K070755) for the Avreo InterWorks™ System does not include details about acceptance criteria, device performance studies, or clinical validation. This submission is for a Picture Archiving and Communications System (PACS) and primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, rather than presenting a performance study with specific metrics and acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

Here's why and what's missing:

• Acceptance Criteria & Reported Performance: The document states that "A comparison of the technological characteristics of the predicate and legally marketed devices available has been performed." and "Avreo, Inc. concludes that the intended use for the Avreo InterWorks™ System is that of the predicate devices, and that the technological characteristics demonstrate that they are equivalent to the predicate device." However, it does not provide a table of acceptance criteria or specific performance metrics for the device itself.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): None of these details are present because a formal performance study (e.g., a clinical trial or reader study) demonstrating the device's accuracy or efficacy against specific acceptance criteria was not part of this 510(k) submission. For PACS systems, the primary focus for substantial equivalence often revolves around functionality, interoperability (DICOM compliance), and safety rather than a performance study measuring diagnostic accuracy.
• Training Set Details: Similarly, no information about training sets is provided as this type of medical device (a PACS system) does not typically involve machine learning or AI models that require training data in the same way as diagnostic algorithms.

In essence, this 510(k) relies on the established safety and effectiveness of its predicate devices through a comparison of technological features, rather than presenting new performance data against a set of acceptance criteria.

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