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To evacuate air and/or fluid from the chest cavity or mediastinum.

To help re-establish lung expansion and restore breathing dynamics.

To facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.

Atrium Medical Corporation Express™ Chest Drain

This document is solely a 510(k) clearance letter for the Atrium Express Chest Drain. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Therefore, I cannot populate the requested table and information based on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a comprehensive premarket notification submission that details the performance data.

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