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The Dominant 35 cfi Suction Pump is indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from wounds or from a patient's airway or respiratory support system, either during surgery or at the patients bedside. Generally the Dominant 35 c/i is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal, wound and thoracic drainage (must be used only in combination with a chest drainage unit with a built in flow adjustment valve) in either "constant" or "intermittent" mode.

The Dominant 35 c/i Powered Suction Pump is an advancement of the approved Medela® Basic 30 and Dominant 50 Series of Secretion and Surgical Aspirators, which are all based on the well-proven Medela pistoncylinder system.

The Dominant 35 c/i Powered Suction Pump provides the choice of two suction modes:

• -Constant Suction (c) with a flow rate of 35 liters/min (high flow)
• Intermittent Suction (i) with a flow rate of 8 liters/min (low flow) and default settings of 16 seconds ONTime / 8 seconds OFFTime.

The new Dominant 35 c/i is based on the Dominant 50 and has additionally fixed to it's housing a jar holder which quarantees that the iar is approximately 20 cm above patient level.

The Dominant 35 c/i is an AC-powered aspirator and incorporates an ACmotor with gearbox, pistons and cylinders, an operation panel, a vacuum gauge in kPa and mmHG, a self-bleeding membrane vacuum regulator, a safety device of polysulfone with overflow protection device and connection tubing, an electric cord and an instruction manual.

The standard version includes a mobile stand with fitting rails 10 x 25 mm and four antistatic castors, two with locking device. The internal and external foot "ON/OFF"-switches have been retained unchanged, but please note, that these switches are only active while working in the constant mode!

The provided text describes a 510(k) submission for the Medela® Dominant 35 c/i Suction Pump, aiming to demonstrate substantial equivalence to predicate devices, rather than a study with specific acceptance criteria related to AI performance or detailed clinical efficacy.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding a study proving acceptance criteria for a device, particularly those referencing AI performance metrics, clinical trials, or expert adjudication, cannot be filled from the given text as this information is not present. The submission focuses on technological equivalence and intended use.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly state "acceptance criteria" in the context of numerical performance metrics for the Dominant 35 c/i. Instead, the submission aims to demonstrate that the new device is "substantially equivalent" to predicate devices, implying that its performance is at least comparable and that there are no new issues regarding safety and effectiveness.

The reported device performance features are:

• Intermittent Suction (i) with a flow rate of 8 liters/min (low flow) and default settings of 16 seconds ON-Time / 8 seconds OFF-Time |
  | Technological Characteristics | Based on the Dominant 50, with an additional operation panel to choose constant or intermittent mode and change time settings in intermittent mode. Technology is identical to legally marketed (unmodified) devices. |
  | Safety and Effectiveness | Concluded to be safe and effective for the intended use, based on technological characteristics being identical to predicate devices and not raising new aspects regarding safety and effectiveness. |
  | Intended Use | Same as the predicate devices: aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from wounds or from a patient's airway or respiratory support system. Includes nasopharyngeal, tracheal, surgical, gastrointestinal, wound, and thoracic drainage. |

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 submission is a 510(k) for a powered suction pump, which typically relies on demonstrating equivalence to existing devices rather than new clinical trials with test sets in the context of AI or diagnostic performance studies.

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)

Not applicable. This information is not relevant to a 510(k) submission for a powered suction pump and is not present.

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

Not applicable. No such study or adjudication method is mentioned.

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. The device is a powered suction pump, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a powered suction pump, not an AI algorithm.

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

Not applicable. The submission focuses on demonstrating equivalence in mechanical performance and safety, not on diagnostic accuracy against a ground truth.

8. The sample size for the training set

Not applicable. The device is a mechanical suction pump, not an AI model requiring a training set.

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

Not applicable. (See #8)

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