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The OLYMPUS UM-S30-25R ULTRASONIC PROBE have been designed to be used with an OLYMPUS Endoscopic Ultrasound System for intraluminal sonographic imaging of the upper airways and tracheobronchial tree.

The Olympus UM-S30-25R Ultrasonic Probe has been designed to be used with an Olympus Endoscopic Ultrasound center, Probe Driving Unit and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree. The probe is connected to the endoscopic ultrasound center through the probe driving unit. The probe is attached to the endoscope which allows the user to use probe. The probe is inserted into the patient through a channel of the endoscope. A probe driving unit controls the rotation of the transducer. UM-S30-25R Ultrasound Probe produces a B-mode scans using the de-aerated water immersion method and balloon method. The probe offers 360 degree mechanical /radial scanning of the tissue under observation. The outer diameter of the insertion tube is 2.4mm and the length is 2050mm.

This document is a 510(k) Summary for the OLYMPUS UM-S30-25R ULTRASONIC PROBE and associated ancillary equipment for bronchial use. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly addressed in this type of regulatory submission. The document emphasizes non-clinical tests for design and material compliance to established standards, which are a different kind of "acceptance criteria."

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The document refers to non-clinical tests (e.g., for electrical safety, EMC, material compatibility) rather than a clinical "test set" with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as there is no mention of a formal clinical test set or ground truth establishment by experts in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as there is no mention of a formal clinical test set or adjudication process in this document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study is not mentioned in this 510(k) summary. This document is for an ultrasonic probe, not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

A standalone performance study for an algorithm is not applicable and not mentioned in this document, as the device is an ultrasonic probe and not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided as there is no mention of a formal clinical test set or ground truth in this document. The "ground truth" for this type of submission largely resides in meeting prescribed engineering and safety standards, as well as demonstrating equivalence to previously cleared devices.

8. The sample size for the training set

This information is not applicable as this document describes a physical medical device (ultrasonic probe), not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

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