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

The subject devices are single use aspiration needles to be used in conjunction with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).

The subject devices consist of a handle section, needle section, and sheath section and needle sizes ranging from 19 to 25G are available. The subject devices are sterilized and packaged in a sterilization package. The Syringe (VACLOK Syringe and Stopcock), which is supplied by Merit Medical System and packaged in an individual sterilization package, is bundled. The subject devices and the Syringe are put in one carton. When users use the device, the syringe is attached to the aspiration port on the handle section of the subject devices.

This document describes the premarket notification (510(k)) for the Olympus Single Use Aspiration Needle NA-U200H. It does not contain information about an AI/ML device or its performance criteria. The performance data provided are for a medical device (a biopsy needle) based on sterility, biocompatibility, and bench/animal/clinical performance evaluations, not AI/ML model metrics.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets those criteria, as the provided text pertains to a traditional medical device premarket notification.

If you have a document describing an AI/ML device, please provide it, and I will do my best to extract the relevant information.

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