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

The APLIO 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, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.

This a medical device 510(k) Premarket Notification. The provided text is a summary of safety and effectiveness, and as such, it does not describe acceptance criteria for performance, nor does it present any studies proving the device meets specific performance criteria.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices. Substantial equivalence means that the new device is as safe and effective as a legally marketed device that it is compared to (the predicate).

Therefore, I cannot extract the requested information about acceptance criteria and performance studies because it is not present in the provided text. The document primarily identifies the device, its intended use, safety considerations, and lists the transducers that are substantially equivalent to previously cleared devices.

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