Search Results

The Olympus Distal Attachment is intended to be used for the following:

• a) for use with electrosurgical snares for endoscopic mucosal resection within the gastrointestinal tract; and
• b) for use in keeping the suitable depth of endoscopic field of view.

Olympus Distal Attachment has the shape of short transparent tube. Olympus Distal Attachment is to be attached to the distal end of the endoscope to facilitate endoscopic therapy.

The provided document is a 510(k) summary for the Olympus Distal Attachment. It details its purpose and comparison to a predicate device, but it does not contain details about acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human improvement with AI vs. without AI assistance
6. If a standalone performance (algorithm only) study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This document primarily focuses on demonstrating substantial equivalence to a previously marketed device (Olympus MH-189) based on design, materials, and intended use, rather than presenting a performance study with specific acceptance criteria.

Ask a specific question about this device