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The Medela Vario 8/18/ci Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from a patient's airway or respiratory support system, either during surgery or at the patient's bed-side.

Generally the Medela Vario 8/18/ci is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal in either "constant" or "intermittent" mode.

The Medela Vario 8/18/ci suction pump is an AC or AC/DC-powered aspirator and incorporates in its medium sized housing a motor with a flat belt power transmission to the pistons and cylinders, an ON/OFF-switch, a vacuum gauge in kPa and mmHg, a membrane vacuum regulator, an overflow protection device (hydrophobic filter) and connection tubing, an electric cord and an instruction manual.

With its QuatroFlex™ technology, the drive power is transferred to the four piston/cylinder modules by means of high-grade, flexible thin-films hinges. The required suction value is rapidly built-up. High suction performance and low weight are positive features of the Vario pump.

The Models Vario 18 "high vacuum" suction pump have a suction capacity of 18 liters per minute and a maximum vacuum up to -75 kPa (-563 mmHg). The pump is marked "low flow high vacuum".

The Model Vario 18 c/i "medium vacuum" suction pump has a suction capacity of 18 liters per minute and a maximum vacuum up to -55 kPa (-375 mmHg). The pump is marked "low flow medium vacuum".

The Models Vario 8 "low vacuum" suction pump have a suction capacity of 8 liters per minute and a maximum vacuum up to -9 kPa (-68 mmHg). The pump is marked "low flow - low vacuum".

A variety of reusable and disposable accessories are available.

This document describes the FDA's acceptance of the Medela Vario 8/18/ci Suction Pump. As such, it details testing and compliance with various standards but does not include a comparative study with a test set, ground truth established by experts, or any elements that involve analyzing performance against a specific set of criteria where the "device performance" would be distinct from simply meeting regulatory standards.

Therefore, many of the requested sections (2-8) cannot be answered from the provided text. The document focuses on showing substantial equivalence to a predicate device rather than a standalone performance study as would be seen for AI/ML devices or novel therapies.

Here's a summary of the information that can be extracted or inferred from the provided text, along with explanations for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on demonstrating compliance with recognized voluntary standards and showing that the device's technical characteristics are substantially equivalent to a predicate device, with expanded specifications supported by testing. The "reported device performance" is essentially that the device met these standards and specifications.

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. The testing described is primarily engineering and bench testing against standards and specifications, not clinical data with a "test set" in the context of device performance on patients or specific cases.

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 and therefore not provided. "Ground truth" established by experts is typically for clinical data assessment (e.g., image interpretation, diagnosis), which was not part of this submission as per section 10 ("SUMMARY OF CLINICAL TESTS: Clinical testing was not required...").

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

Not applicable, as there was no test set requiring expert 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 device is a powered suction pump and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is irrelevant.

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

"Standalone" performance in this context refers to the device's ability to operate according to its specifications (e.g., flow, vacuum, battery life). The non-clinical tests described are indeed standalone tests of the device's physical and functional performance. It is not a standalone algorithmic performance as might be seen for an AI/ML device.

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

The "ground truth" for the non-clinical tests was established by published voluntary standards (e.g., ISO, IEC, EN ISO) for safety and performance, as well as the manufacturer's own internal specifications which were validated against the predicate device. There was no expert consensus, pathology, or outcomes data used to establish ground truth in this context.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product and does not involve a "training set."

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

Not applicable, as there is no training set for this type of device.

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