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The Ardo Suction Pumps master and senator are indicated for vacuum extraction, aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.

The Ardo Suction Pumps master and senator are high performance suction pumps with maintenance-free glass piston/cylinder technology and a modern, functional design. They are the successor models of the egnell compact suction pump operating on the same basic principles. The mechanical over-flow safety device in the lid jar and the bacterial filter protect the pump against contamination. The suction pump is connected to the collection jars by means of collapse-resistant suction tubing. A longer piece of patient tubing is also connected to the jar. The latter transports the fluids from the patient to the jar. However, the tubing does not contact the patients directly. When the suction pump is switched to the ON position, the circuits direct electrical current from the external AC power supply to the pump/motor assembly. The pump operates to evacuate air from the collection jar. The resulting subatmospheric condition causes air to flow upward from the patient suction tubing and into the jars. Vacuum can be set by turning the adjustment knob. The difference between the master and senator is the suction capacity (master: 45 liter/minute, senator: 30 liter/minute). All other features are substantially equivalent.

The provided text does not contain detailed information regarding acceptance criteria for device performance or a specific study that proves the device meets those criteria in the context of clinical or diagnostic accuracy. Instead, it describes a medical device, the Ardo Suction Pumps (master and senator), and its regulatory submission (510(k)).

The document states that the device was tested against recognized international standards for medical suction equipment and general safety:

• ISO 10079-1: Medical Suction Equipment Part 1: Electrically powered suction equipment
• ISO 10079-3: Medical Suction Equipment -- Part 1: Suction equipment powered from a vacuum or pressure source
• IEC 601-1: Medical Electrical Equipment -- Part 1: General requirements for safety

These standards typically define performance requirements (e.g., maximum vacuum pressure, flow rate, safety features) and testing methodologies for such devices. Therefore, the "acceptance criteria" are implied to be compliance with these standards, and the "study" is the testing performed against these standards.

Here's an attempt to answer your questions based only on the provided text, acknowledging that much of the requested information for AI/diagnostic devices is not applicable to this type of medical hardware submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states the device "was tested" against these standards, implying compliance, as the FDA granted 510(k) clearance based on these tests.

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

• This information is not explicitly stated. For a hardware device like a suction pump, "sample size" typically refers to the number of units tested, which is not detailed.
• Data provenance: Not applicable in the context of clinical data. The tests were likely conducted in a laboratory setting by the manufacturer or a third-party testing facility.

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. The "ground truth" for a mechanical device is its adherence to engineering specifications and safety requirements defined by the standards. No clinical experts were involved in establishing a diagnostic ground truth for this type of device.

4. Adjudication method for the test set

• Not applicable. The tests against the standards are objective measurements, not subjective evaluations requiring adjudication.

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

• Not applicable. This is a medical hardware device, not an AI/diagnostic imaging system.

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

• Not applicable. This is a medical hardware device, not an algorithm. The device functions independently in its suction capacity.

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

• The "ground truth" for this device is based on engineering specifications and safety standards (ISO 10079-1, ISO 10079-3, IEC 601-1). Compliance with these standards confirms the device's functional and safety performance.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device; there is no "training set."

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

• Not applicable. There is no training set for this type of device.

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