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The Endoscopic Ultrasound Aspiration Needle is designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope in adult patients only.

The proposed Endoscopic Ultrasound Aspiration Needle is a sterile single-use device, designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope.

It consists of three parts, Aspiration Needle, Syringe and Stopcock. The aspiration needle is offered with multiple types with different dimension, needle tip design and needle material. Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample.

There are 12 specifications, the difference is the diameter, material and tip design of needle.

The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10t and placed in a sterility maintenance package to ensure a shelf life of 2 years.

This document is a 510(k) summary for the Endoscopic Ultrasound Aspiration Needle, which is a medical device. It does not contain information about the acceptance criteria or a study proving the device meets performance criteria for an AI/ML powered device. The document focuses on regulatory approval for this specific type of medical device by demonstrating substantial equivalence to predicate devices, not on proving performance through specific metrics associated with AI/ML.

Therefore, I cannot provide the requested information. The document does not describe:

• Acceptance criteria in terms of AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
• A study that proves the device meets such acceptance criteria.
• Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth types related to an AI/ML algorithm.
• Training set sample size or how ground truth for a training set was established.

This document describes a traditional medical device approval process based on comparison to existing legally marketed devices, not an AI/ML product.

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