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This instrument has been designed to be used with the ultrasonic endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).

This instrument has been designed to be used with the ultrasonic endoscope for ultrasonically guided fine needle aspiration(FNA) of submucosal and extramural lesions of the gastrointestinal tract(i.e. pancreatic masses, mediastinal masses perirectal masses and lymph nodes).

The NA-10J-KB consists of a handle section and a sheath section. This instrument is designed to be used with the needle section, MAJ-363.

The handle section is connected to the endoscope channel opening.

The handle section facilitates to advance the sheath section and the needle section manually. And the handle section projects the needle section rapidly by its spring mechanism. This spring mechanism is equipped to facilitate puncturing of indurated lesions. The projection length by the spring mechanism is adjustable.

The setting for projection length by spring-loaded needle is determined by observing the ultrasonic image.

The provided document describes an Olympus NA-10J-KB Aspiration Needle and its 510(k) submission for market clearance. It does not contain information about acceptance criteria, device performance, a specific study proving the device meets acceptance criteria, or details regarding AI/machine learning components.

The document is a regulatory submission for a medical device (aspiration needle) and focuses on demonstrating substantial equivalence to a predicate device (Olympus NA-10J-1 Aspiration Needle K973128) based on intended use, method of operation, material, or design. It explicitly states: "When compared to the predicate device, the Olympus NA-10J-KB Aspiration Needle does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness."

Therefore, based on the provided text, I cannot extract the information required for your request, as it pertains to AI/ML device validation which is not present in this document.

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