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For endoscopic ultrasound applications using the balloon method in the upper or lower gastrointestinal tract.

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The provided text is a U.S. FDA 510(k) clearance letter for a medical device called the "Ultramatrix EUS Balloon." This document is a regulatory communication and does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing the manufacturer to market it. It outlines regulatory requirements the manufacturer must adhere to but does not include any performance data, study designs, or ground truth establishment details.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, qualifications of experts, or adjudication methods for a test set.
3. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
4. Information on a standalone algorithm performance study.
5. Type of ground truth used.
6. Sample size for the training set.
7. How ground truth for the training set was established.

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