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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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• To evacuate air and/or fluid from the chest cavity or mediastinum. .
• To help re-establish lung expansion and restore breathing dynamics. .
• To facilitate collection of autologous blood from the patient's pleural cavity or . mediastinal area for reinfusion purposes in post-operative and trauma blood loss management.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the Atrium Medical Corporation Express™ Chest Drain, indicating that the device is substantially equivalent to legally marketed predicate devices.

The letter lists the indications for use but does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or the number/qualifications of experts.
• Information on adjudication methods, MRMC studies, or standalone algorithm performance.
• Specifics about the type of ground truth used or the training set for any AI/algorithm.

Therefore, I cannot fulfill your request for this specific document.

Ask a specific question about this device