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For use on any patient 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 or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube.

· Clinical Settings: For use in a hospital / institutional environment, or in the home, given adequate training and a physician's prescription.

• Patient Population: For use on children and adults. It should not be used on neonates and infants.

• Contraindications: Any patient with a history of bullous emphysema, known susceptibility to pneumothorax or pneumomediastinum or known to have any recent barotrauma, should be carefully considered before use.

The Comfort Cough is a portable electric device which utilizes a blower and a valve to apply alternately a positive and then a negative pressure to a patient's airway in order to assist the patient in clearing retained bronchopulmonary secretions. It includes a means to adjust the pressure and suction levels applied, a pressure gauge to measure the pressures, and a means to reduce the positive pressure flow. The Comfort Cough system includes accessories such as a breathing hose, a face mask, an adapter and a power cable, but not a bacteria filter. The Comfort Cough can be used with a 510K cleared bacteria filter made by other manufacturers. The compatible size information is specified in the manual.

The provided 510(k) summary for the Comfort Cough (SICC2001) device describes performance testing to support its substantial equivalence, but it does not provide a typical acceptance criteria table with specific performance metrics and a detailed study proving the device meets those criteria in a clinical or robust standalone setting.

Instead, the submission focuses on:

• Compliance with safety standards: IEC/EN60601-1 and 60601-1-2.
• Bench testing comparison: A side-by-side test with a predicate device (Cough Assist K002598) to compare pressure and flow rates.
• Toxicological safety: Tests for volatile organic compounds (VOCs), carbon monoxide (CO), carbon dioxide (CO2), particulate matters, and ozone (O2).

Here's a breakdown of the available information based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide a table of acceptance criteria with specific numerical targets for performance metrics (e.g., minimum pressure, flow rate, or accuracy ranges) that the device must meet to be considered "accepted."

Instead, it states the following with respect to performance:

Note: The submission highlights the "similar performance" without quantifying the similarity or defining what range constitutes "similar."

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

The document does not specify a "sample size" in the context of a clinical test set with patient data. The performance claims are based on:

• Bench Testing: An unspecified number of tests for electrical safety and toxic substance emissions.
• Side-by-side comparison: A bench test comparing the Comfort Cough to a predicate device (Cough Assist K002598). The sample size for this comparison (e.g., how many devices of each type were tested, how many measurements were taken) is not provided.
• Data Provenance: The tests appear to be laboratory/bench tests conducted by the manufacturer or a contracted lab. There is no indication of clinical data from patients (retrospective or prospective), and thus no country of origin for such data.

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

Not applicable. The reported studies are bench tests directly measuring physical parameters (pressure, flow, emissions) or compliance with technical standards. They do not involve expert interpretation or establishment of ground truth in a clinical sense.

4. Adjudication Method for the Test Set

Not applicable, as no clinical ground truth or expert-adjudicated test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The submission does not describe any MRMC comparative effectiveness study involving human readers or the effect of AI assistance. This device is a mechanical medical device, not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The entire performance data presented is "standalone" in the sense that it evaluates the mechanical and electrical performance of the device itself (Comfort Cough) and compares it to a predicate device through bench tests. There is no algorithm or AI component mentioned, nor is there any "human-in-the-loop" performance being measured.

7. The Type of Ground Truth Used

For the bench testing described:

• Electrical Safety: Standards (IEC/EN60601-1 and 60601-1-2) themselves serve as the "ground truth" or reference for compliance.
• Pressure and Flow Rate: The performance of the predicate device (Emerson Cough Assist, K002598) served as the comparative reference. The implicit ground truth is that the new device should perform similarly to the legally marketed predicate.
• Toxic Emissions: Established EPA, OSHA, and NIOSH methods and thresholds served as the ground truth for determining safe emission levels.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical medical device and does not involve AI or machine learning algorithms that require a "training set."

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

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

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