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The SonoTip II Endobronchial Ultrasound-Guided Transbronchial Fine Needle Aspiration, (EBUS-TBNA) Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II EBUS-TBNA Needle System is used for ultrasonically guided fine needle aspiration, (FNA) of submucosal and extra-luminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract.

The Medi-Globe SonoTip II EBUS-TBNA Needle System is a complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single patient use only.

The provided text describes a medical device submission (510(k)) for the Medi-Globe SonoTip II EBUS-TBNA Needle System. However, it does not contain the detailed information required to answer your specific questions about acceptance criteria and the study proving the device meets those criteria.

The document makes a general statement about performance data:

"Design verification data has demonstrated that the proposed Medi-Globe SonoTip II EBUS-TBNA Needle System meets the same performance requirements and is as safe and effective as Medi-Globe's currently cleared predicate device."

This indicates that the device's performance was compared to a predicate device, and it was found to be "as safe and effective." However, it does not provide the specifics of:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document only states the device "meets the same performance requirements" as the predicate.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned. This type of study is more common for diagnostic imaging AI algorithms, not typically for a needle system.
6. If a standalone performance study was done: The wording suggests performance was evaluated relative to a predicate, not necessarily in a standalone clinical trial with specific performance metrics.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not applicable as this is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on its intended use, technological characteristics, and general range of descriptive features. It does not include a detailed breakdown of specific performance acceptance criteria or the study data proving those criteria were met, which is typical for a 510(k) summary that emphasizes equivalence rather than novel performance claims backed by clinical trials.

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