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Intended Use: AS-XXXX Suction Pump is intended to be used to remove bodily fluids from a patient's airvay or respiratory system.

The AS-XXXX (FAMILY SERIES) suction pump is a portable AC-powered suction pump. The AS-XXXX (FAMILY SERIES) suction pump creates a negative pressure (vacuum) that draws fluids through a disposable suction catheter that is connected by suction tubing to a collection container. The suctioned fluids are then trapped in the collection container for proper disposal. The device must only be used on the order of a physician. If practiced outside of the hospital setting, the care giver must be trained by a certified healthcare professional and the training must be recorded and documented. The AS-XXXX (FAMILY SERIES) suction pump consists of an on/off switch, a pump unit, a power cord, a collection container, relief valve, pressure adjustment knob, pressure gauge, microbial filter, long intermediate tubing, short intermediate tubing, and suction tubing. Disposable suction catheters are not packaged with this device and must be purchased separately.

The provided text describes the acceptance criteria and the study for the Ding Hwa AS-XXXX (Family Series) Suction Pump.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "non-clinical performance testing" and the results meeting "acceptance criteria," but does not detail the methodology, sample sizes, or data provenance for these tests beyond citing the standards. This device is a hardware product (suction pump), not an AI device, so typical AI study parameters like "test set" and "data provenance" often don't apply in the same way.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable for this type of medical device (a suction pump) and is not provided in the document. The "ground truth" for a suction pump would be its adherence to established performance and safety standards, not expert consensus on diagnostic images or other data typically associated with AI.

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

This information is not applicable for this type of medical device and is not provided in the document.

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 for this type of medical device (suction pump). MRMC studies are typically for medical imaging diagnostics or similar AI-assisted interpretation, which is not relevant here.

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

This information is not applicable for this type of medical device. The device is a physical pump, not an algorithm.

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

The "ground truth" for this device's performance is established through compliance with recognized international and national standards for medical electrical equipment and suction equipment, specifically:

• IEC 60601-1, 3rd Ed. (General Requirements for Basic Safety and Essential Performance)
• IEC 60601-1-2 (Electromagnetic compatibility)
• ISO 10079-1 (2009): Medical suction equipment -- Part 1: Electrically powered suction equipment -- Safety requirements.

The device also based its "ground truth" on substantial equivalence to a predicate device (EMG Suction Unit, Model SUA01-AXX Series 510(k)112421), implying its performance matches that of an already cleared device.

8. The sample size for the training set

This information is not applicable for this type of medical device. "Training set" is a concept related to machine learning and AI, not mechanical medical devices like a suction pump.

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

This information is not applicable for this type of medical device.

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Suction pump 2207 with its accessories is used to aspirate liquids in ultrasound lithotripsy. It has been designed for combined use with the ultrasound generator 2271 for aspiration of disintegrated kidney stones, bladder stones and ureter stones and the liquid involved.

The Suction pump 2207 is a roller pump that generates a continuous vacuum for aspirating the particles and liquids during ultrasound lithotripsy into a fluid trap (bottle).

The provided text describes a 510(k) summary for a medical device, the Richard Wolf Suction Pump 2207. It does not contain information about a study proving the device meets specific acceptance criteria in the way a diagnostic AI/ML device would. Instead, it describes general safety and performance aspects for regulatory submission.

However, I can extract information related to what would be considered "performance" in a medical device context for this submission:

Here's the breakdown of the available information structured to match your request, with an emphasis on what's not present:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. This document refers to the regulatory submission for a physical medical device (suction pump), not a diagnostic algorithm or a study with a test set of data. The "testing" mentioned is likely internal engineering and electrical safety testing.
• Data Provenance: Not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. Ground truth as typically defined for AI/ML models (e.g., expert consensus on images) is not relevant for this type of device submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method

• Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical suction pump, not a diagnostic imaging AI.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study: No, a standalone algorithm performance study was not done. This is a physical device, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the context of AI/ML. For this physical device, "ground truth" would refer to its physical conformity to engineering specifications and safety standards. The document states it conforms to UL 2601 and IEC 601-1.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no training set mentioned, as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not applicable.

In summary, the provided document describes a 510(k) submission for a medical device (a suction pump) focusing on its intended use, technological characteristics, and conformance to existing safety standards. It explicitly states, "No clinical tests performed." The "performance data" refers to compliance with electrical safety standards, not clinical efficacy trials or AI/ML diagnostic performance metrics.

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