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

The subject device is a Single Use Aspiration Needle NA-U200H to be used with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).

The subject device consists of a handle section, needle section, and sheath section. When users use the device, the syringe needs to be attached to the subject device. The subject device is used to obtain an acceptable specimen. The lesion is punctured by the Needle equipped at the distal end of the subject device and aspirated by the syringe. Subsequently, the tissue of the lesion in the needle is taken out by feeding air from the syringe or pushing the tissue with the stylet for sampling.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter and a 510(k) summary for the "Single Use Aspiration Needle NA-U200H".

While it states that "Performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended," and that "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007," it does not provide specific details on:

• A table of acceptance criteria and reported device performance (with specific metrics and values).
• Sample sizes used for test sets or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
• Standalone algorithm performance (as this is a physical medical device, not an AI algorithm).
• Type of ground truth used.
• Sample size for the training set (again, not applicable to a physical device in the context of AI).
• How ground truth for the training set was established.

This document focuses on regulatory clearance by demonstrating substantial equivalence to predicate devices, rather than detailed performance study results with specific acceptance criteria that would be typical for an AI/software device.

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