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MultiView is a software application that is intended for use in processing, manipulating, and displaying magnetic resonance imaging (MRI) images as well as other multi-modality DICOM medical images and data that it receives from various sources (e.g. CT. US, secondary capture devices, scanners, imaging sources, and imaging gateways).

MultiView provides various image processing and measurement tools to facilitate the interpretation of breast MRI images and enable diagnosis. These computer-aided and/or userdefined processing functions include artifact minimization, image subtractions, multi-planar reformats, and maximum intensity projections. It also includes the following automatic functions: physiological analysis tools, diffusion analysis, and segmenting of lesions. MultiView also provides tools for automated targeting for breast interventional procedures.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and accepted by the FDA.

MultiView is typically used by trained professionals, including radiologists. technologists and clinicians and may provide information to be used for screening, diagnostic and interventional procedures. Patient management decisions should not be made solely on the results of MultiView analvsis.

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The provided text is a 510(k) clearance letter from the FDA for the device "MultiView." It describes the device's intended use and FDA's determination of substantial equivalence. However, this document does not contain the detailed acceptance criteria for the device's performance, nor does it describe the specific study that would prove the device meets these criteria.

The 510(k) clearance focuses on regulatory equivalence, not a detailed technical performance study with acceptance criteria and results. Such detailed information would typically be found in the manufacturer's 510(k) submission document itself, which is not provided here.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document states what the device is, its regulation, and the FDA's regulatory decision, but not how its performance was evaluated against specific metrics.

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