Search Results

The SmartGuide is intended for use in punctures of anatomical sites such as in organs, cysts, lymph nodes, and tissue spaces, for purposes of aspiration biopsy, drainage, injection, or fluid collection. SmartGuide can be used in punctures where non-penetrable anatomic obstacles (e.g. bone, spine) or vital structures (e.g. blood vessels, nerves) are to be avoided. The device is intended for use in environments such as CT and radiographic ultrasound.

The SmartGuide is a puncturing device capable of extending an inner cannula which deflects in a curved shape.

The provided text is a 510(k) summary for a medical device called "SmartGuide." This document describes the device, its intended use, and claims substantial equivalence to predicate devices. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested information based solely on the input text. The 510(k) summary focuses on regulatory submission requirements and substantiating claims of equivalence, not detailed performance studies or statistical analyses of device accuracy.

Ask a specific question about this device