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The Olympus NA-10J-1 Aspiration Needle is specifically designed to be used with the Olympus GF-UM30P ultrasound gastroscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes).

Olympus NA-10J-1 Aspiration Needle

This is a 510(k) premarket notification for a medical device (Olympus NA-10J-1 Aspiration Needle) and does not contain information about acceptance criteria or a study proving device performance in the context of AI/algorithm-based diagnostic devices.

The provided document is a regulatory submission for a physical medical device (an aspiration needle) and focuses on establishing substantial equivalence to a predicate device for market clearance. It primarily covers:

• Device Name and Intended Use: Specifies the Olympus NA-10J-1 Aspiration Needle for ultrasonically guided fine needle aspiration (FNA) of lesions.
• Regulatory Classification: Identifies the classification name (Gastroenterology-Urology Biopsy Instruments) and product code (78 FOG).
• Predicate Device: States the Olympus NA-1C Aspiration Needle (K904667) as the predicate.
• FDA Clearance Letter: Confirms the FDA's review and determination of substantial equivalence, allowing the device to be marketed.

Therefore, the requested information regarding acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/algorithm-based device is not present in this document. This document describes a traditional medical device, not an AI/ML diagnostic system.

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The Olympus NA-10J-1 Aspiration Needle is specifically designed to be used with the Olympus GF-UM30P ultrasound gastroscope for ultrasonically guided fine needle aspiration (FNA) within the gastrointestinal tract.

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This document is a 510(k) summary for a medical device (Olympus NA-10J-1 Aspiration Needle). It does not contain the kind of information requested in the prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.). This document is a regulatory submission, not a study report or clinical trial summary.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device