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Endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures as follows:
Clinical Application: Trans-esoph. (non-Card.), Other (spec.)
Mode of Operation: B, M, Combined (Spec.) B+M, Other (Spec.) Note 1
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, and imaging for guidance of biopsy.
Note 2: Specification for "Other" (1) the airways and tracheobronchial tree.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Trans-esoph. (non-Card.), Other (spec.)
Mode of Operation: B, M, Combined (Spec.) B+M, Other (Spec.) Note 1
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, and imaging for guidance of biopsy.
Note 2: Specification for "Other" (1) the airways and tracheobronchial tree.

Not Found

This document is a 510(k) summary for the OLYMPUS BF type UC160F-OL8 EVS EXERA Ultrasonic Bronchofibervideoscope.

The provided document describes the intended use and clinical applications of the device, which are limited to Diagnostic Ultrasound Indications for Use.

However, it does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone).

Therefore, I cannot provide the requested information based on the provided text. The document is primarily a regulatory submission outlining the device's classification and intended uses for substantial equivalence to a predicate device, not a performance study report.

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