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The Lung Flute® Therapeutic is indicated for Positive Expiratory Pressure (PEP) therapy.

The Lung Flute® Therapeutic is shaped like a pipe or flute with a plastic mouthpiece at one end. A Mylar reed is attached inside a square hardened plastic tube that flairs on the end to increase the internal air mass, which provides acoustical impedance. When the patient exhales through the "flute-like" device, the reed inside the tube oscillates and acts in tandem with the rest of the device and the lung cavity itself to produce a sound frequency that approximates the resonance frequency of pulmonary secretions. The Lung Flute® Therapeutic facilitates mucus clearing by generating and delivering a specific low frequency sound that vibrates the airways and lung secretions, causing lung secretions to thin and become expelled.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Performance standards have not been established by the FDA under section 514 of the Federal, Food, Drug and Cosmetic Act." Therefore, the acceptance criteria are implicitly derived from demonstrating substantial equivalence to the predicate device, Acapella.

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

The document does not explicitly state the exact sample size for the clinical study (test set). It mentions "A cohort of chronic bronchitic patients". The provenance of the data (country of origin, retrospective or prospective) is also not specified.

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

This information is not applicable. The device is a therapeutic device for mucus clearing, not a diagnostic device requiring expert interpretation for ground truth establishment. The performance was assessed through objective and patient-reported measures, not expert annotation.

4. Adjudication Method for the Test Set

This information is not applicable as the study did not involve expert adjudication of results.

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

This information is not applicable. The device is a therapeutic device, not an AI-assisted diagnostic tool for human readers.

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

This information is not applicable. The device is a physical therapeutic device used by a patient, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" or primary measures of effectiveness were:

• Sputum samples weighed: Objective physiological measurement.
• Spirometry performance: Objective physiological measurement.
• Chronic COPD Questionnaire (CCQ) and St. Georges Respiratory Questionnaire (SGRQ): Patient-reported outcomes.
• Daily diary recordings of breathlessness, cough, and sputum scale (BCSS): Patient-reported outcomes.
• Daily use of emergency inhaler: Patient-reported outcome/behavioral measure.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical therapeutic device, not an AI model that requires a training set.

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

This information is not applicable, as there is no training set for this type of device.

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