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The Penumbra Aspiration Pump is intended for general suction use in hospitals or clinics.

The Aspiration Pump is designed to provide general suction for use in hospitals or clinics. The Aspiration Pump is designed to be powered by the Power supply and is designed to be portable if needed. The Aspiration Pump provides vacuum of up to 558 mmHg.

I am sorry, but based on the provided document, there is no information about acceptance criteria, specific studies, sample sizes, expert involvement, or any performance metrics related to a device's effectiveness or accuracy that would allow me to populate the requested table and answer the subsequent questions.

The document is a 510(k) summary for the Penumbra Aspiration Pump, focusing on its substantial equivalence to a predicate device for general suction use. It mentions that the device "meets both internal performance requirements and Underwriters Laboratory (UL) electrical safety and electromagnetic compatibility testing," but it does not specify what those "internal performance requirements" are, nor does it provide any data from such tests.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set or data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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