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The FAMIO SSA-530A is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, cardiac, transrectal, transvaginal, peripheral vascular and, musculo-skeletal (both conventional and superficial).

The FAMIO SSA-530A Diagnostic Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array and convex array with a frequency range of approximately 3.75MHz to 12MHz.

This document is a 510(k) premarket notification for the Toshiba FAMIO SSA-530A Diagnostic Ultrasound System. It details the device's substantial equivalence to previously cleared devices. The document does not contain information about acceptance criteria or a study proving that the device meets those criteria, as it is a submission for substantial equivalence based on comparison to predicate devices, not an efficacy study.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them because the provided text does not contain this information. The document focuses on establishing substantial equivalence to existing devices rather than presenting new performance data against specific acceptance criteria for a novel device.

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