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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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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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vital Cough device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or pass/fail format relative to a specific study outcome for the Vital Cough device. Instead, it employs a substantial equivalence approach by comparing the Vital Cough's features and performance parameters to a legally marketed predicate device, the Emerson Cough Assist (K002598).

The comparison table serves as the de facto "acceptance criteria" in this context, demonstrating that the Vital Cough performs at a comparable or improved level for key functions.

Note: The FDA's 510(k) clearance process fundamentally relies on demonstrating substantial equivalence to a predicate device, rather than strict, predefined numerical acceptance criteria against a clinical outcome. The "Met Acceptance Criteria?" column reflects whether the Vital Cough meets or exceeds the predicate's performance in the relevant parameter.

Study Proving Acceptance Criteria:

The document describes non-clinical testing to demonstrate compliance and performance:

• IEC 60601-1 general requirements for electrical safety
• IEC 60601-1-2 electromagnetic compatibility standards
• No toxic substances found in the output air of the device
• Conformity to ISO 9703 anesthesia and respiratory care alarm signals (auditory and visual)

Beyond these safety and performance standards, the primary "study" proving the device meets the acceptance criteria (i.e., is substantially equivalent) is the key feature comparison table itself, which presents direct measurements and design aspects of the Vital Cough against the predicate. This comparison would have involved internal engineering testing and measurements to generate the reported flow and pressure values.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical trial or image dataset. The "test set" here refers to the device itself and its measured performance. There's no mention of a human or patient test set for evaluating the device's immediate efficacy or diagnostic accuracy. The values (+50 cm H2O, 7.3 liters/sec, etc.) are likely derived from laboratory measurements of a small number of manufactured units or prototypes.
• Data Provenance: The data (flow rates, pressures) are technical measurements from the device itself, presumably generated through internal testing by Lung Assist, Inc. The country of origin for this data would be the USA (Boulder, CO) where Lung Assist, Inc. is located. It is
  retrospective in nature, as these measurements would have been completed prior to submission.
• Retrospective or Prospective: Retrospective, as these are measurements taken from the device prior to submission for clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable to this type of device and submission. "Ground truth" in the context of device performance usually refers to clinical outcomes or expert labels. For a mechanical device like Vital Cough, the "ground truth" for its operational parameters (pressure, flow) is established by direct physical measurement using calibrated equipment, not by expert consensus or clinical assessment.

4. Adjudication Method for the Test Set

Not applicable. There's no multi-reader or observational data requiring adjudication in this technical comparison.

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 Vital Cough is a mechanical medical device, not an AI-powered diagnostic or assistive tool for human readers. There are no "human readers" or "AI assistance" involved in its direct function.

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

Not applicable. This is not an algorithm or AI device. Its performance is inherent in its mechanical and software design.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims (e.g., maximum inhalation flow of 7.3 liters/sec, positive pressure of +50 cm H2O) is based on direct engineering measurements and physical testing of the Vital Cough device using calibrated instrumentation.

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning or AI that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is used.

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