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The LibAirty Airway Clearance System is intended to provide airway clearance therapy and promote bronchial drainage when external manipulation of the thorax is the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging.

The LibAirty Airway Clearance System is intended for hospital, home, and clinic use.

The LibAirty Airway Clearance System is designed to assist in the loosening and elimination of mucus from the lungs. It consists of a vest with inflatable chambers, connected to a control unit (equipped with an air compressor) that inflates and deflates the vest in a pre-defined cycle, and a mobile application.

The LibAirty Airway Clearance System was designed to provide airway clearance therapy when external manipulation of the thorax is the physician's choice or treatment, while using an inflatable vest connected to an air supply unit.

The LibAirty Airway Clearance System is designed to promote breathing at different volumes, as the inflatable vest applies oscillating pressure on the chest and back, to augment peripheral and tracheal mucus movement towards the airway opening. The system's mode of operation is inspired by the principles of the Autogenic Drainage (AD) airway clearance technique, in which adjusting the depth and location of lung volumes during respiration generates shearing forces induced by airflow which loosen, mobilize, and move secretions (i.e., mucus) from the peripheral towards the central airways. Once the mucus reaches the larger airways, it can be expelled through coughing.

The LibAirty™ Airway Clearance System is a mobile, non-sterile, single patient use device, operated by mains power supply only.

The LibAirty™ Airway Clearance System consists of:

• . A control unit equipped with an air compressor that delivers air at regulated pressures to the vest and includes a display screen and operation buttons allowing the user to adjust therapy settings and manage device operation.
• . An inflatable vest (available in different sizes) that is fastened around the chest and consists of several air chambers.
• . A hose bundle that transfers the air from the control unit to the vest's chambers.
• . A Mobile Application (App) that is used to operate the system and provide instructions.

Synchronization Medical's LibAirty Airway Clearance System is an airway clearing device designed to promote bronchial drainage and aid in secretion clearance. The device consists of a vest with inflatable chambers, a control unit with an air compressor, and a mobile application. It operates by applying oscillating pressure to the chest and back, promoting movement of mucus from peripheral to central airways, where it can be expelled by coughing. The core principle of operation is based on Autogenic Drainage (AD) airway clearance technique.

The device was compared to the predicate device, The Vest Airway Clearance System, cleared under K142482.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list "acceptance criteria" in a quantitative manner for specific performance metrics from a clinical study for the purpose of regulatory clearance. Instead, it demonstrates substantial equivalence to a predicate device through a comparative clinical study. The primary effectiveness endpoint was the sputum weight expectorated. Non-clinical performance data included various verification and validation tests, but their specific acceptance criteria values (e.g., specific thresholds for pressure, noise, etc.) are not detailed in this summary.

Given the available information, the table below reflects the primary clinical performance finding and the general conclusion regarding acceptance:

2. Sample Size and Data Provenance

• Test Set Sample Size: 28 subjects completed the entire study.
• Data Provenance: The study was a randomized controlled two-sequence crossover study performed at the Medical University of South Carolina, Charleston, South Carolina, USA. It was a prospective clinical study designed for regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

The provided document does not specify the number of experts used to establish ground truth or their qualifications. The primary effectiveness endpoint was objectively measured sputum weight, which does not inherently require expert consensus for its establishment as ground truth in the same way an image interpretation study might.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set. Since the primary endpoint was the objective measurement of sputum weight, it's unlikely that an adjudication process (common in subjective assessments or image interpretation) would be necessary for this primary outcome.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or conducted as described for AI-assisted image interpretation. This study compared two devices (LibAirty and The Vest) in a crossover design based on objective sputum weight.
• Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable here, as this is a medical device performance study, not an AI diagnostic aid study.

6. Standalone (Algorithm-Only) Performance

• This concept is not applicable to the LibAirty Airway Clearance System. The LibAirty system is a physical medical device (vest, compressor, mobile app) that directly provides therapy, not a diagnostic algorithm. Its performance is intrinsically linked to its physical application by a human user (the patient).

7. Type of Ground Truth Used

• The primary ground truth used for the clinical effectiveness comparison was objective outcomes data: the weight of sputum expectorated. This is a direct physiological measure of the device's effectiveness in aiding secretion clearance.

8. Sample Size for the Training Set

• The concept of a "training set" is not applicable to this medical device, as it is not an AI/machine learning model that learns from a dataset. The LibAirty system is a physical device.

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

• This question is not applicable as there is no "training set" for this physical medical device.

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