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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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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 patients bedside.

Generally the Medela Vario 8/18/ci is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal and thoracic drainage (in combination with a water seal or dry seal chest drain) in either "constant" or "intermittent" mode. Especially for thoracic drainage the Medela Vario 8 is indicated in situations such as pneumothorax, after surgery (post operative), thorax injury, pleura effusion, pleuryempyem or other related conditions.

This notification for the Medela® Vario 8/18/ci Suction Pumps is for labeling change and to include additional indications. There have been no significant modifications or design changes to the currently cleared and marketed Medela® Vario, 510(k) No. K983552.

The Medela® Vario 8/18/ci Suction Pumps is a further innovative development of Medela's well-proven piston/cylinder system. 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 Medela® Vario 8/18/ci is an AC or an AC/DC-powered portable aspirator and incorporates in its medium sized housing an AC respectively DC-motor with a flat belt power transmission to the pistons and cylinders, an ON/OFF-switch, a vacuum gauge in kPa and mmHG, a self-bleeding membrane vacuum regulator, an overflow protection device (hydrophobic filter) and connection tubing, an electric cord and an instruction manual.

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

The Medela® Vario 18 "medium vacuum" suction pump has a suction capacity of 18 liters per minute and a maximum vacuum up to -50 kPa (-375 mmHq). The pump is marked "low flow - medium vacuum".

The Medela® Vario 8 "low vacuum" suction pump has 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. A variety of disposables for thoracic drainage are also available.

The provided text is a 510(k) summary for the Medela® Vario 8/18/ci Powered Suction Pumps. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. However, this document does not contain specific acceptance criteria, study details, or performance data in the way a clinical study report would.

The core of this 510(k) summary is that the new device is substantially equivalent to legally marketed predicate devices, meaning it is considered as safe and effective as those devices because there are no significant modifications or design changes that would raise new aspects regarding safety and effectiveness. The only modifications noted are a change from lead acid to NiMH batteries and more differentiated trade names.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not present in this type of regulatory filing because they are typically not required when demonstrating substantial equivalence for minor modifications.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

1. A table of acceptance criteria and the reported device performance

Explanation: The document states that the new device is "identical in construction and performance" to the predicate device (K983552) and that the modifications (battery type and naming) do not "significantly affect the safety or effectiveness." This implies that the device meets the performance and safety standards established for the predicate device. The specific acceptance criteria for these standards are not detailed in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No sample size, test set details, or data provenance information (country, retrospective/prospective) are provided in this 510(k) summary. The submission relies on demonstrating substantial equivalence to already cleared devices rather than providing new clinical test data.

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. No new clinical test set requiring expert ground truth establishment is mentioned in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new clinical test set 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. This device is a powered suction pump and does not involve AI or human readers for diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a powered suction pump and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new ground truth was established for this submission, as it relies on substantial equivalence. The "ground truth" for its safety and effectiveness is the regulatory clearance of its predicate device(s).

8. The sample size for the training set
Not applicable. This device is a powered suction pump and does not involve an algorithm that requires a training set.

9. How the ground truth for the training set was established
Not applicable. This device is a powered suction pump and does not involve an algorithm that requires a training set.

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