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The VibraPEP™ Mucus Clearing Device is a Positive Expiratory Pressure, PEP device. It was designed to exercise patient's lungs and to improve secretion clearance. The device may be connected via a Valved T-adapter for use with a jet nebulizer for aerosol drug delivery. The VibraPEP™ Mucus Clearing Device is not intended to be used while connected to a jet nebulizer which is delivering nebulized steroidal drugs or antibiotics.

The proposed device is the identical VibraPEP™ cleared under K153441 but with a Valved T-adapter and mouthpiece that allow the user to connect a general purpose jet nebulizer.

The VibraPEP™ is an Oscillatory PEP (OPEP) device that looks like a curved shaped pipe with a plastic mouthpiece at one end. A long hose is attached inside. As the patient blows through the VibraPEP™, the hose pressure increases and buckles at the bending of the tube. When the peak pressure is reached, the hose end opens and is catapulted against the wall releasing its pressure. This process is repeated, providing an oscillation effect with pressure during the exhalation phase. By rotating the therapy selector, pressure and flow can be adjusted to achieve optimal therapy for each patient. The VibraPEP™ facilitates mucus clearing by generating and delivering an oscillation effect that vibrates the airways and lung secretions, causing lung secretions to thin and become expelled.

This document is a 510(k) Summary for the VibraPEP™ Mucus Clearing Device, detailing its substantial equivalence to previously cleared devices. It primarily focuses on the device's physical and functional characteristics, and its performance in comparison to predicate devices, particularly regarding its use with a nebulizer.

However, the provided text does not contain information typically found in acceptance criteria or study designs for performance of an AI/ML device. This document describes a medical device (a mechanical positive expiratory pressure device), not an AI/ML algorithm. Therefore, many of the requested elements regarding AI/ML device performance (e.g., sample size for AI test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) are not applicable or present in this document.

I will attempt to answer the questions based on the information available, noting when the information is not present or not applicable to this type of device.

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

The document frames "performance" in terms of physical characteristics (pressure, amplitude, flow, frequency) and how these are maintained when new accessories are added, rather than acceptance criteria for an AI model's output metrics (e.g., accuracy, sensitivity, specificity). The acceptance criterion is implicitly that the device's performance characteristics are "not significantly changed" or "no differences" compared to the predicate devices, ensuring functional equivalence.

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

• Test Set Sample Sizes:
  • For PEP Performance: "samples of the VibraPEP™ with the T-adapter" were tested, and compared to "the VibraPEP without T-adapter" and "the predicate RC Cornet and its T-adapter." Specific number of samples/units is not provided, but it implies multiple units were tested for consistency.
  • For Nebulizer Performance: "samples of cleared small volume jet nebulizers" were tested. Specifically, two types of nebulizers (Westmed - VixOne and Hudson RCI MicroMist) were tested with 3 different drugs. The number of samples/units for each nebulizer type is not specified.
  • For Biocompatibility: "all components of the VibraPEP including the new components" were tested.
  • For Aging, Cleaning, Drop Testing: "samples of the VibraPEP™" and "new components, Valved T-adapter and mouthpiece" were tested.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of performance testing for a mechanical device, these would almost certainly be prospective lab experiments rather than studies on patient 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)

This is not applicable as this is a mechanical device, not an AI/ML algorithm requiring expert interpretation of output. The "ground truth" for performance is measured by physical parameters (pressure, flow, particle size) using standard testing methodologies and equipment, not human expert consensus.

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

Not applicable. This is not an AI/ML or diagnostic device that requires human expert adjudication of results. Performance is measured objectively.

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 mechanical medical device, not an AI/ML diagnostic or assistive technology for human experts.

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

Not applicable. This is a mechanical device, not an algorithm.

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

The "ground truth" here is the result of objective physical measurements of the device's performance characteristics (pressure, amplitude, flow, frequency) and particle size distribution for nebulizer efficacy, using standard laboratory equipment and test methods. There is no biological "ground truth" in the way one might have for diagnostic medical devices.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML system. There is no "training set."

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

Not applicable. There is no training set for a mechanical device.

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