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The GIP/ Medi-Globe Needle System for Ultrasonic FNA is specifically designed for ultrasonically guided fine needle aspiration (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes).
The Medi-Globe Needle System for Ultrasonic FNA is designed to be used with the Pentax FG32, 34, 36, 38 UA ultrasound endoscopes for ultrasonically guided fine needle aspiration (FNA of submucosal and extra-luminal lesions of the gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes).

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The provided document is a 510(k) summary for the GIP/Medi-Globe Needle System for Ultrasonic FNA. It is a premarket notification for a medical device and, as such, does not contain the detailed information required to describe acceptance criteria and a study proving a device meets those criteria.

510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device, rather than providing comprehensive efficacy studies that would include acceptance criteria, performance metrics, sample sizes, ground truth establishment, or human reader studies.

Therefore, none of the requested information can be extracted from the provided text, as it focuses on regulatory submission details and claims of substantial equivalence.

Specifically, the document does not contain information related to:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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