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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:

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