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The Exhale Probe is intended for blood-flow detection and electrosurgery procedures (i.e. coagulation/cauterization, hemostasis, etc.) in the upper airways and tracheobronchial tree through a bronchoscope.

The Exhale Probe is a multi-function catheter that provides: (1) Doppler audio output in the presence of pulmonary vessel blood-flow; and (2) radiofrequency (RF) energy to a target site within the upper airway or tracheobronchial tree. The probe is inserted into through the 2 mm working channel of a standard bronchoscope and connects to the Exhale Doppler Processing Unit and a standard, commercially available, electrocautery radiofrequency generator.

This document is a 510(k) summary for the "Exhale Probe," a medical device cleared by the FDA in 2001. It describes the device and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trials for new medical devices or AI algorithms.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices. Substantial equivalence is a pathway for market clearance where a new device is shown to be as safe and effective as a legally marketed device (the predicate). This usually involves demonstrating similar intended use, technological characteristics, and performance, often through non-clinical testing.

Therefore, I cannot provide the requested information for this specific device based on the provided text. The document is primarily a regulatory submission demonstrating equivalence, not a performance study against predefined acceptance criteria.

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