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The Siemens Digital Stereotactic Biopsy Attachment System (DSBAS) marketed as OPDIMA (Optimized Digital Mammography) is a digital small field x-ray option for the commercially available Mammomat 3000 mammographic x-ray system. The Mammomat 3000 with DSBAS option is intended for use in small field mammographic x-ray imaging. Such small field imaging is used during stereotactic biopsy and spot localization.

The fully functional OPDIMA mammographic x-ray system configuration consists of the commercially available Mammomat 3000 mammographic x-ray system configured with the DSBAS (Digital Stereotactic Biopsy Attachment System) option. The Mammomat 3000 with DSBAS option is a Digital Stereotactic Biopsy Mammography System intended for use in small field digital mammographic examinations. The Mammomat 3000 with the DSBAS option consists of the Mammomat 3000 stand and generator configured with a camera assembly, i.e., CCD detector, biopsy unit and a workstation for the display and processing of images, modem, MO drive, trolley, Biopsy controller and DSBAS software (Application Software and Biopsy Controller software).

The provided text does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding ground truth establishment, expert involvement, or sample sizes for training and test sets.

The document is a 510(k) summary for a medical device (Digital Stereotactic Biopsy Attachment System for a mammographic x-ray system) and focuses on describing the device's technical characteristics, intended use, and its substantial equivalence to predicate devices. It does not include a detailed performance study with acceptance criteria.

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