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The Resound EUS-FNA device is intended for sampling targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

The Resound Endoscopic Ultrasound Aspiration Needle (EUS-FNA) is an endoscopic ultrasound aspiration needle that can be coupled to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope with a standard luer connection and delivered into the digestive tract. The needle is used to acquire aspiration samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. An aspiration sample is obtained by penetrating the lesion with the needle while applying suction.

The provided text describes a medical device, the Resound™ Endoscopic Ultrasound Aspiration Needle (EUS-FNA), and its 510(k) submission for substantial equivalence. However, the document does not contain information related to specific acceptance criteria, studies proving the device meets those criteria, or details regarding performance data in the structured format requested (e.g., sample sizes, expert qualifications, MRMC studies, ground truth establishment methods).

The "Performance Data" section explicitly states:

• "Bench Testing has been performed on the finished Resound EUS-FNA device to demonstrate that the proposed device is substantially equivalent to the predicate devices."

This indicates that the main type of study conducted was bench testing (physical and/or mechanical testing), not clinical performance studies involving human subjects or AI algorithms, which are typically where the detailed performance metrics, sample sizes, and expert adjudications mentioned in your request would originate.

The submission focuses on demonstrating substantial equivalence to predicate devices (Wilson-Cook EchoTip Ultrasound Needle and Olympus Single-Use Aspiration Needle) based on technological characteristics and bench testing, rather than establishing specific clinical performance metrics against a defined set of acceptance criteria.

Therefore, I cannot provide the requested information from the given text because it is not present. The document focuses on regulatory approval through substantial equivalence, which often relies on non-clinical data for devices of this type (biopsy needles used for aspiration).

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