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The ASA01 Heavy Duty Suction Pump is a vacuum suction device designed to remove bodily fluids from the patients' airway or respiratory support system. It is intended for use by trained personnel under the direction of the physician.

The ASA01 Heavy Duty Suction Pump is an AC-powered, stand-alone device, designed to collection of nonflammable fluid materials in medical applications.

The provided text describes a 510(k) submission for the ASA01 Heavy Duty Suction Pump, but it does not contain specific acceptance criteria or a study proving the device meets them in the way typically expected for an AI/CADe device.

This device is a physical medical device (a suction pump), not an AI or software-controlled device for diagnostic imaging or similar applications. Therefore, many of the requested categories (like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "ground truth" in the context of image interpretation, "training set size") are not applicable to this type of submission.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance

The submission focuses on demonstrating "substantial equivalence" to a predicate device (K052650 Pioneer U601 Series Aspiration) rather than meeting precise performance metrics derived from a clinical study for diagnostic accuracy.

Table of Acceptance Criteria and Reported Device Performance (as far as applicable to this type of device):

Study Details (as applicable)

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

   • Test Set Sample Size: Not applicable in the context of a "test set" for AI/CADe performance. The evaluation was primarily through bench testing and compliance with standards.
   • Data Provenance: Not applicable for a physical suction pump. The testing was laboratory-based.

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

   • Not applicable. "Ground truth" in the AI/CADe sense (e.g., expert interpretation of images) is not relevant for a physical suction pump's functional testing.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. This concept applies to human reader consensus for diagnostic truth, which is not part of this device's evaluation.

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, not a physical suction pump.

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

   • No, a standalone (algorithm only) study was not done. This device does not involve an "algorithm" in the AI sense. Its performance is inherent to its physical operation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable. The "ground truth" for a suction pump would be its ability to achieve certain vacuum pressures, flow rates, and maintain sterility, as measured by calibrated equipment and adherence to engineering specifications and standards.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

   • Not applicable, as there is no training set.

Summary for this specific device:

The ASA01 Heavy Duty Suction Pump is a basic physical medical device. Its acceptance criteria and proof of performance are based on engineering bench testing, compliance with relevant industrial and medical device standards (IEC, ISO), hazard analysis, and demonstrating "substantial equivalence" in technological characteristics and intended use to a legally marketed predicate device (K052650 Pioneer U601 Series Aspiration). Concepts related to AI/CADe performance evaluation (like ground truth, test sets, training sets, reader studies) are not relevant to this submission.

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