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The SmartSuction Solo device is an AC-powered, stand-alone device designed to be used as a suction source to replace wall suction in the operating room to remove fluids and debris from the surgical field during surgical procedures. The SmartSuction Solo device is intended for use by trained personnel under the direction of the physician.

The SmartSuction Solo device is not intended for endotracheal suction. The SmartSuction Solo device automatically adjusts suction up to 150 mmHg negative pressure when the suction tip is occluded. Do not use SmartSuction Solo device as a suction source in any procedure where 150 mmHg of suction could damage underlying tissue.

This device is intended for use by trained personnel under the direction of a physician. The attending physician is responsible for the proper use of these devices. Therefore, the device is to be used as a prescription medical device, which is indicated in the labeling as "Rx only".

Haemonetics® SmartSuction Solo™ (HSS) is a product line extension from the SmartSuction HARMONY™ device, which was cleared by FDA under K052626 in October 2005. The SmartSuction Solo device is an AC-powered, stand-alone device designed to be used as a suction source to replace wall suction in the operating room to remove fluids and debris from the surgical field during surgical procedures. The SmartSuction Solo device is intended for use by trained personnel under the direction of the physician. The attending physician is responsible for the proper use of these devices. Therefore, both these devices are to be used as a prescription medical device, which is indicated in the labeling as "Rx only".

Both electromechanical devices are the same and consist of a vacuum pump and control circuitry.

The provided text describes a 510(k) premarket notification for the Haemonetics® SmartSuction Solo™ device. It establishes substantial equivalence to a predicate device, the SmartSuction HARMONY™. However, the document does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format explicitly requested.

The document states: "Performance Testing - Bench Haemonetics has conducted testing to verify the electrical safety and performance characteristics as described in the Operation Manual. A detailed list of testing is provided with test protocols and reports." This indicates that performance testing was conducted, but the specifics of what those characteristics were, what the acceptance criteria for them were, and the results of those tests are not included in the provided text.

Therefore, I cannot fully complete the requested table and answer all questions directly from the provided input. However, I can extract the available information and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific quantitative acceptance criteria (e.g., maximum allowable leakage current, minimum/maximum flow rates, precise suction pressure ranges beyond "up to 150 mmHg").
• Detailed test results for each of the performance characteristics.

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

The document does not specify a "test set" in the context of a clinical study with patients or human subjects. The performance testing mentioned is "Bench testing." Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) for a clinical study is not provided.

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

This information is not applicable as the document describes bench testing, not a study involving expert-established ground truth for a test set of data.

4. Adjudication method for the test set

This information is not applicable as the document describes bench testing, not a study requiring adjudication of a test set.

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

This information is not applicable. The device is an AC-powered suction device, 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. The device is a physical medical device, not an algorithm. Bench testing constitutes a "standalone" evaluation of the device's technical performance.

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

For the bench testing, the "ground truth" would be established by engineering specifications, industry standards, and the predicate device's performance characteristics. The document states, "Haemonetics has conducted testing to verify the electrical safety and performance characteristics as described in the Operation Manual." This implies the operational manual and internal specifications serve as the "ground truth" against which the device's performance was measured.

8. The sample size for the training set

This information is not applicable. The document describes a physical medical device and bench testing, not a machine learning model requiring a training set.

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

This information is not applicable. The document describes a physical medical device and bench testing, not a machine learning model requiring a training set.

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