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The Merits Pioneer U601 Series Aspirator is to be used to remove bodily fluids from the patients' airway or respiratory support system. It is for use on the order of a physician only

The Merits Pioneer U601 Series Aspirator operates using standard AC Power from a wall outlet. This device consists of a motor-driven oil-less dual piston pump, a vacuum regulation components, a gauge, a bacterial filter and collection system.

The provided text is a 510(k) summary for the Merits Health Products Pioneer U601 Series Aspirator. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed performance study information specifically requested in your prompt.

Specifically, the document states under "9.8 Performance": "The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device." And under "9.9 Conclusion": "Based on the design, performance specifications and testing and intended use, the Merits U601 Aspirator is substantially equivalent to the currently marketed device, Thomas Aspirator model 1135."

These statements indicate that performance testing was conducted, and the device met specifications, but the document does not provide the specific acceptance criteria, reported performance values, or any details about the study design (sample sizes, ground truth establishment, expert qualifications, etc.).

Therefore, I cannot populate the table or answer most of your questions based solely on the provided text.

Here's a breakdown of what can and cannot be answered from the provided text:

1. Table of acceptance criteria and reported device performance:

• Cannot be provided. The document states "the device meets specifications" but does not list the specifications or the specific performance results.

2. Sample size used for the test set and the data provenance:

• Cannot be provided. No information on sample sizes or data provenance for any testing is included. This is typically found in the test reports, which are not part of this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A. Since this is a physical medical device (aspirator) and not an AI/imaging device, the concept of "ground truth" established by human experts for a test set in the way you've described for AI models does not directly apply here. Performance testing for an aspirator would typically involve engineering tests (e.g., vacuum pressure, flow rate, durability) against established technical standards.

4. Adjudication method for the test set:

• N/A. See point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• N/A. This is a physical aspirator, not an AI-powered diagnostic or decision-support system. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• N/A. See point 5.

7. The type of ground truth used:

• N/A. Performance is likely assessed against engineering specifications and possibly clinical performance metrics as defined by relevant standards for aspirators (e.g., ISO, ASTM).

8. The sample size for the training set:

• N/A. This is not an AI algorithm that requires a "training set."

9. How the ground truth for the training set was established:

• N/A. See point 8.

In summary: The provided 510(k) summary confirms that performance testing was done and the device met its specifications to demonstrate substantial equivalence to the predicate. However, it does not detail what those specifications were or how the testing was conducted in the granular manner requested by your prompt for AI/diagnostic studies. This type of detailed performance data (acceptance criteria, test methods, results) is typically found in the full 510(k) submission, not the summary.

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