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The Dideco D902 Lilliput 2 Membrane Oxygenator is intended for use in infants less than 20 Kg (44 Lb.) who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir is intended to collect blood during normal operation, to always assure the proper oxygenation capability of the device. The D 902 LILLIPUT 2 should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

Dideco D902 Lilliput 2 Membrane Oxygenator

The provided document is a 510(k) clearance letter from the FDA for the "Lilliput 2 Infant Hollow Fiber Oxygenator." This document is a regulatory approval for a medical device and does not contain any information about acceptance criteria, device performance studies, or the methodologies for validating AI or other software-based medical devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This type of information would typically be found in a separate clinical study report or a detailed technical submission to the FDA, not in the clearance letter itself.

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