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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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