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Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.

Apogee 1100 Digital Color Doppler Ultrasound Imaging System with Convex Array Transducer C3L60C, Linear Array Transducer L8L38C, Convex Array Transducer C5L40C, Phased Array Transducer P3F14C

The provided document is a 510(k) clearance letter from the FDA for an ultrasound imaging system. It primarily lists the approved indications for use for the system and its various transducers. Crucially, it does not contain information about acceptance criteria or specific studies demonstrating the device meets those criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not present in the provided text.

The document essentially states what the device is cleared for, not how its performance was evaluated against specific metrics.

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