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The Basic 30 and Dominant 50 Suction Pumps are indicated for vacuum extraction, aspiration an removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from removal or from a patient's airway or respiratory support system, either during surgery or at the patients bedside.

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This document is a 510(k) clearance letter from the FDA for the Medela AG Basic 30 and Dominant 50 suction pumps. It states that the FDA has found the device to be substantially equivalent to legally marketed predicate devices.

The letter does not contain information about:

• Acceptance criteria and reported device performance.
• Sample size, data provenance, or details of a test set.
• Number or qualifications of experts, or adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• Sample size for the training set or how ground truth for the training set was established.

Therefore, I cannot provide the requested information based on the provided text. This document is a regulatory clearance and not a performance study report.

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