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The Vibralung Acoustical Percussor is indicated as an airway secretion clearance device that creates vibrations in the airways and as a lung expansion device that applies Positive Expiratory Pressure (PEP) as a patient breathes through the device. It may be used to promote bronchial drainage, airway clearance and expectoration. The Vibralung may be used simultaneously with aerosol drug delivery.

The proposed Vibralung Acoustical Percussor provides airway clearance therapy (ACT) and promotes mucokinesis by inducing vibration in airways by vibrating the column of gas in the airways at a variety of different frequencies. It is an acoustic device that induces oscillatory sound waves by means of an electro-acoustical transducer (audio speaker), referred to as the "Hand-held Transducer" or HHT, which is interfaced to the patient's airway through a mouthpiece. The transducer unit is connected to a frequency generator, referred to as the "Treatment Control Unit" or TCU, which is set to produce frequencies between 5 and 1,200 Hz in different ranges that are user-selectable.

The HHT directs sound waves into the patient's airways through a waveguide and a mouthpiece.

In addition, the Vibralung can provide Positive Expiratory Pressure (PEP) and may simultaneously provide nebulized aerosol drug delivery.

There are two different Y-adapters available that act as "waveguides" to direct sound waves from the audio speaker in the HHT to the mouthpiece that is held in the patient's mouth in the same manner as with other breathing treatment mouthpieces.

The purpose of the Y-adapters is two-fold:

• · To direct the sound waves into the airway opening, and
• · To provide separate pathways for inhalation and exhalation gas flow with minimal mixing and rebreathing of exhaled gas.

Here's a breakdown of the acceptance criteria and study information for the Vibralung Acoustical Percussor, based on the provided document:

Acceptance Criteria and Device Performance

The document describes a substantial equivalence comparison rather than explicitly stating numerical acceptance criteria for device performance against predefined thresholds. Instead, the device's performance is deemed "substantially equivalent" to predicate devices, implying that its performance is comparable and acceptable. The core "performance" criteria are based on its ability to generate acoustic frequencies and provide Positive Expiratory Pressure (PEP) within ranges consistent with the physiological effects of the predicate devices.

Table of Acceptance Criteria (Implied by Substantial Equivalence) and Reported Device Performance:

Study Information

2. Sample Sizes Used for the Test Set and Data Provenance:

• Study 1: 10 subjects (mild to moderate Cystic Fibrosis). Retrospective/Prospective information is not explicitly stated, but the description "were subjected to two treatments... on two different days" suggests a prospective, interventional design. The country of origin is not specified.
• Study 2: 11 subjects. Retrospective/Prospective information is not explicitly stated, but the description "designed to assess the effects... for five days" suggests a prospective, interventional design. The country of origin is not specified.
• Non-clinical Testing: Details on sample size for components/materials are not provided, only the types of tests performed.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the sense of independent review or adjudication of study outcomes. The studies focused on objective physiological measurements (LCI, sputum production, pulmonary function) and safety assessments.

4. Adjudication Method for the Test Set:

Not applicable. The studies did not involve subjective assessments requiring adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:

Not applicable. This device is not an AI-powered diagnostic or interpretive tool that would involve human readers or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a medical device for airway clearance, not an algorithm. The "standalone" performance would be its inherent physical and physiological effects, which are what the non-clinical and clinical studies assess.

7. The Type of Ground Truth Used:

• Clinical Studies (Study 1 & 2): Physiological measurements and clinical outcomes, such as:
  • Lung Clearance Index (LCI)
  • Pulmonary function (FVC, FEV1)
  • Peripheral oxygen saturation (SaO2)
  • Total sputum production (wet weight, pellet weight, dry weight)
  • Patient symptoms and safety assessments.
• Non-Clinical Testing: Engineering and performance specifications, such as inspiratory resistance, airway pressure, sound pressure level, mechanical dead space, particle characterization (for aerosol performance), acoustical testing (frequency ranges), electrical safety (IEC standards), accelerated aging, and cleaning validation.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI or machine learning system that requires a "training set."

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

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

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