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The Safersonic® Sonography Cover is intended to be used as a sterile, single-use protective cover of an ultrasonic transducer. The Safersonic provides a sterile, microbial barrier between the transducer and the patient's tissue, helping to prevent the transfer of microorganisms, body fluids and particulates to the patient. The Safersonic Covers are for use during procedures with sector, linear, intravaginal and rectal transducers.

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This document is an FDA 510(k) clearance letter for the Safersonic® Sonography Cover. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The information provided describes a decision by the FDA that the Safersonic® Sonography Cover is substantially equivalent to legally marketed predicate devices for its intended use as a sterile, single-use protective cover for ultrasonic transducers. The letter refers to the device's function as a sterile, microbial barrier to prevent the transfer of microorganisms, body fluids, and particulates.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study from this document as it pertains to the type of device described (a physical medical cover, not an AI/ML algorithm).

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