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The Pulmonary Cytology Brush is intended to allow brush sampling of tissue or cells from the upper or lower respiratory tract and/or to perform surveillance cultures

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This document is a 510(k) Premarket Notification decision letter from the FDA for a device named "Pulmonary Cytology Brush." It explains that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this document is NOT a study report for an AI/ML medical device. It does not contain any information about acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes, expert qualifications, ground truth establishment, or any of the other details typically found in a clinical study report for an AI device.

The Pulmonary Cytology Brush is a physical medical instrument used for sampling tissue/cells, not an AI/ML algorithm that requires performance studies measuring its diagnostic or prognostic accuracy. Therefore, the requested information (acceptance criteria, study details, human reader performance, training set details) is not applicable to this document.

To answer your request, I would need a different type of document, specifically a clinical study report or a 510(k) submission summary for an AI/ML-based medical device.

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