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The Aerobika* Oscillating Positive Expiratory Pressure device intended for use as a Positive Expiratory Pressure (PEP) device. The Aerobika* Oscillating PEP device may also be used simultaneously with nebulized aerosol drug delivery. The device is intended to be used by patients capable of generating an exhalation flow of 10 lpm for 3 – 4 seconds.

The Aerobika* OPEP with Manometer device combines Positive Expiratory Pressure (PEP) with oscillations upon exhalation with visual feedback relative to the patient's expiratory pressure. The device is mechanically driven using only the energy from the patient's exhaled breath. Upon exhalation, a portion of the patient's exhaled breath is routed through the manometer device and exits through it. While the manometer is pressurized by the patient's exhaled breath, an indicator contained within the manometer housing indicates the patient's exhaled pressure. The manometer adapter consists of plastic components constructed of polypropylene material, and the manometer is a purchased component to TMI, and is previously cleared under K040991.

This document, a 510(k) Premarket Notification for the Aerobika* OPEP with Manometer, describes non-clinical testing performed to establish substantial equivalence to a predicate device. It does not contain information about clinical studies with human participants. Therefore, many of the requested details about acceptance criteria for clinical performance, ground truth, expert adjudication, or MRMC studies are not applicable or available in this document.

Here's a breakdown of the available information:

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

The document details several non-clinical tests performed. While explicit "acceptance criteria" are not numerically stated in a table format, the narrative indicates that the device "meets specifications and performs comparably to the predicate Aerobika* OPEP device." The performance reported is that the device did meet these specifications.

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

This document describes non-clinical laboratory testing. Specific sample sizes for each mechanical or environmental test are not provided in this summary. The data provenance is Trudell Medical International, located in London, ON, Canada, conducting design verification and validation activities. The studies are prospective in nature as they are conducted for the purpose of the 510(k) submission.

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 document describes non-clinical mechanical and material testing, not diagnostic or clinical performance requiring expert ground truth establishment.

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

Not applicable. This document describes non-clinical mechanical and material testing, not diagnostic or clinical performance 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 device is not an AI-assisted diagnostic tool, and no MRMC study was conducted.

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

Not applicable. This device is a mechanical OPEP device, not an algorithm. The "standalone" performance refers to the device's inherent mechanical function. The non-clinical testing evaluates this.

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

For the non-clinical tests, the "ground truth" is established by engineering specifications, recognized standards (like ISO 10993-1:2009 for materials), and the performance characteristics of the legally marketed predicate device (Aerobika* OPEP device, K123400).

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for a mechanical device.

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The Vital Cough is intended for use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. For use in a hospital, institutional setting, or home use given adequate training. For use on adult or pediatric patients.

The device is an electromechanical software controlled device housed in a metal and polymer case. A touch screen displays outputs and receives commands from the user. The device develops positive and negative pressure through an adjustable blower. In inhale mode the lungs are inflated. The device rapidly shifts to providing negative pressure with the intended goal of rapidly deflating the lungs to stimulate an effective patient cough. A flutter feature developed by an oscillator butterfly valve may be activated during exhalation to assist in loosening and removing secretions.

Here's a breakdown of the acceptance criteria and the study information for the Vital Cough device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for the Vital Cough with flutter feature are implicitly established through substantial equivalence claims to two predicate devices: the Vital Cough without a flutter feature (K120277) and the Acapella flutter device (K002768). The study aims to demonstrate that the new device's performance, particularly with the added flutter feature, is comparable and safe for its intended use.

Explicit Performance Characteristics and Comparison:

Summary of Device Meeting Acceptance Criteria:

The Vital Cough with flutter demonstrates substantial equivalence primarily by matching or exceeding the performance characteristics of its predicate devices where applicable.

• Pressure and Flutter Characteristics: It achieves the same maximum positive/negative pressures as the original Vital Cough (K120277) and offers a comparable flutter frequency range and waveform technology to the Acapella (K002768).
• Fundamental Functionality: The core MI/E (Mechanical Insufflation-Exsufflation) design is present in both the new device and the predicate Vital Cough. The added flutter feature is directly compared to the Acapella.
• Indications for Use: The new device maintains the same broad indications for use as the original Vital Cough, which covers a wider patient population and method of use than the Acapella.
• Operating Modes and Settings: It shares the same microprocessor-controlled automatic and manual modes, and adjustable time intervals as the original Vital Cough.

The submission specifically highlights that "The Vital Cough with flutter is substantially equivalent to the Vital Cough cleared device cleared under K120277 based on intended use, comparative testing, frequency and waveform. The MIE design is in both devices. The added flutter feature has the same indication for use to clear secretions as the original Vital Cough and the Acapella. The pressure and flow differences are due to the Vital Cough MI/E activity. The flutter activity is substantially equivalent. The Vital Cough with flutter is a mechanical device driven by a fan. The Acapella is driven by himan effort. The Vital Cough device does the work for the patient."

Study Information

The 510(k) summary provided does not describe a clinical study involving human subjects or a large-scale data analysis (like an AI study). Instead, it relies on non-clinical testing to demonstrate substantial equivalence.

1. Sample size used for the test set and the data provenance: Not applicable. The documentation refers to "comparative testing" and "waveform characterization and analysis" between the new device and the predicate devices, implying bench testing and engineering comparisons rather than a human-subject test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic AI or clinical studies, is not established here. The comparison is against established technical specifications and performance characteristics of predicate devices.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 not an AI-assisted diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an electromechanical device, not a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for comparison is the published technical specifications, performance data, and established intended uses of the predicate devices (Vital Cough K120277 and Acapella K002768). For non-clinical testing, this would involve laboratory measurements against those specifications.
7. The sample size for the training set: Not applicable. This device does not use machine learning or AI algorithms requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Non-Clinical Testing Details Provided:

The summary states the following non-clinical testing was conducted:

• Compliance with IEC 60601-1 (general requirements for electrical safety).
• Compliance with IEC 60601-1-2 (electromagnetic compatibility standards).
• Verification that no toxic substances were found in the output air.
• Conformity to ISO 9703 (anesthesia and respiratory care alarm signals, auditory and visual).
• Characterization by pressure and flow of the Acapella predicate and the Vital Cough with flutter feature. This is the core of the performance comparison for substantial equivalence.

In essence, the study focuses on engineering and safety testing to demonstrate that the new device, with its added flutter feature, is functionally equivalent and safe compared to already legally marketed devices, primarily the original Vital Cough and the Acapella.

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