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The Aspiration Pump is indicated for vacuum extractions, aspiration and removal of surgical fluids, bodily fluids, or infection materials during surgical procedures.

The Aspirating Pump consists of battery powered microprocessor controlled diaphragm pump, pressure release valve, and disposable collection chamber with bacterial filter and overflow protection. Suction tubing from a patient connected to collection chamber by means of lure connector.

The provided text is a 510(k) summary for an Aspiration Pump and a letter from the FDA. It details the device's identification, description, intended use, and its substantial equivalence to a predicate device. However, this document does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

The document states:

• Device: Aspiration Pump
• Intended Use: "The Aspiration Pump is indicated for vacuum extractions, aspiration and removal of surgical fluids, bodily fluids, or infection materials during surgical procedures."
• Predicate Device: Medela AG, Basic 30 (510(k) K021368)
• Rationale for Substantial Equivalence: "The Aspiration Pump shares the same general indications for use, similar design features, and functional features as predicated device. Therefore, the technological differences between Aspiration Pump and predicated device do not raise any new issues of safety, effectiveness, or performance of the product. We believe that Aspiration is substantially equivalent to the above legally marketed predicate device."

To address the specific points of your request:

1. A table of acceptance criteria and the reported device performance: This information is not available in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data against specific acceptance criteria.
2. Sample size used for the test set and the data provenance: This information is not available in the provided text. No specific performance testing or clinical study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not available in the provided text. No ground truth establishment is described.
4. Adjudication method for the test set: This information is not available in the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not applicable and not available. The device is an Aspiration Pump, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not applicable and not available. The device is an Aspiration Pump, not an algorithm.
7. The type of ground truth used: This information is not available in the provided text, as no specific performance testing or clinical study is detailed.
8. The sample size for the training set: This information is not available in the provided text. No machine learning model or training set is mentioned.
9. How the ground truth for the training set was established: This information is not available in the provided text.

In summary, the provided document is a regulatory submission for a medical device (an Aspiration Pump) based on substantial equivalence. It does not contain the detailed performance study data, acceptance criteria, or ground truth information typical for an AI/ML device or a device requiring specific performance claims beyond general functional equivalence.

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