Search Results

The PEGASO A-COUGH PERC is designed for the use on patients 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, mouthpiece, or an adapter to a patient's endotrached tube. For use in hospital, institutional setting, or home use given adequate training.

For use on adult patients and pediatric patients 3 years old and up.

The PEGASO A-COUGH is designed for the use on patients 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, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. For use in hospital, institutional setting, or home use given adequate training.

For use on adult patients and pediatric patients 3 years old and up.

The PEGASO COUGH is designed for the use on patients 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, mouthpiece, or an adapter to a patient's endotracheal tube. For use in hospital, institutional setting, or home use given adequate training.

For use on adult patients and pediatric patients 3 years old and up.

The Dima Italia Srl Pegaso Cough assists patients in clearing retained bronchopulmonary secretions by gradually applying a positive pressure to the airway, then rapidly shifting to a negative pressure. This rapid shift in pressure, via a facemask, mouthpiece or an endotracheal or tracheostomy tube, produces a high expiratory flow rate from the lungs, simulating a cough.

The Dima Italia Srl Pegaso Cough is an electric device useful in clearing retained bronchopulmonary secretions. It acts a "cough" patient simulation, applying a positive air pressure to the airway, then rapidly shifting to a negative air pressure. At the end of this pressure shifting, the Pegaso Cough leaves the airways free, at zero pressure, for a pause time determined by operator.

The Inspiratory Flow rising time can be selected on four levels: Peak, High, Medium, Low.

This "Forced Insufflation" is destinated to patients with reduced coughing possibilities due to muscular dystrophy, myasthenia gravis, poliomyelitis respiratory muscles paralysis, such as spinal cord injury. Even patients with other diseases, such emphysema, cystic fibrosis, can be treated with Pegaso Cough.

It can be used with a facemask or, with an adapter, to an endotracheal or tracheostomy tube.

The Pegaso Cough is realized with a blower, used as pressure and flow generator, and a mechanical valve, commanding the sign and the air pressure intensity outing to the patient.

The blower takes air from atmosphere, and compresses it in order to generate a positive or negative pressure. The pressure value is controlled by an electronic sensors.

In order to reduce the risks of adverse reactions, an (optional) Masimo oximeter has been added.

An optional flow sensor (trigger) has been added in order to synchronize the inspiration cycles to the first or all the inspiratory efforts of the patient.

An optional high frequency oscillatory vibration (percussion mode) has been added in order to help to clear retained bronchopulmonary secretions.

So, Pegaso Cough (without options), Pegaso A-Cough (with the trigger option), Pegaso A-Cough Perc (with trigger and percussion options) identification names will be used.

Pegaso Cough, Pegaso A-Cough, Pegaso A-Cough Perc are equivalent devices.

The Inspiratory/Expiratory cycles are determined by the blower rotation and the mechanical valve positioning. This valve is connected to a step-motor, whose position is detected through an optical sensor. The valve lets the positive flow go toward the patient and the negative flow toward the atmosphere or, instead, the positive flow to the atmosphere and the negative flow toward the patient.

The working parameters are visualized on a colour TFT display and modified through a touch keyboard.

The provided text describes the Pegaso Cough, Pegaso A-Cough, and Pegaso A-Cough Perc devices, which are noncontinuous ventilators. The submission is a 510(k) premarket notification for device modifications.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with specific thresholds for device performance. Instead, it details that various features and modifications were verified to meet product requirements/specifications or performed as intended. The "performance data" section focuses on testing methodologies and successful verification of features against design inputs and product specifications, rather than numerical performance metrics against pre-defined acceptance criteria.

However, based on the Comparison of Device technological Characteristics to predicate device and Device Modification Testing Summary, we can infer some performance expectations and the results of the testing:

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

The document does not specify a separate "test set" in the context of patient data or clinical trials. The performance data discussed is based on non-clinical bench testing, black-box testing, white-box testing, software unit testing, code reviews, and simulations.

• Sample Size: Not applicable in the traditional sense of patient samples. The testing involved various worst-case scenario inputs and simulations. For the oximeter verification, a "Clinical Dynamic Simulator Validation Report" was run.
• Data Provenance: The data is generated from bench testing methodologies, simulating use environments and inputs for the device itself. It's retrospective in the sense that it evaluates the device's adherence to pre-defined specifications after manufacturing/design. No country of origin for patient data is mentioned as this was not a clinical study involving patients.

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

Not applicable. This was a non-clinical, bench-testing focused evaluation. There were no "experts" establishing clinical ground truth for a patient test set, nor were patient outcomes involved. The ground truth for the engineering tests was the device's design specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. No "adjudication method" in the context of expert review or consensus for patient data was performed. The verification activities (bench testing, code reviews, etc.) served as the method to determine if the device met its design inputs and relevant standards.

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

No MRMC study was done. This device is a noncontinuous ventilator used for secretion clearance, not an AI-assisted diagnostic or imaging device that would typically involve human "readers." The submission focuses on the safety and effectiveness of the device itself and its modifications, demonstrating substantial equivalence to predicates through engineering and performance testing.

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

Yes, the testing described is primarily standalone device performance. The "device modification testing summary" and "non-clinical testing" sections detail evaluations of the device's various features (User Interface, AutoSync/EasyStart, Oscillations, Data Management, Oximetry Connection, Case, Electrical Safety) independent of human operators, ensuring the device functions according to specifications. While "AutoSync" and "EasyStart" relate to patient inspiratory effort, the testing of these features focuses on the device's ability to detect and respond to that effort, not on human-in-the-loop performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used for these non-clinical tests was the product design specifications, engineering requirements, and recognized international standards (e.g., ISO 14971, ISO 10993-1, IEC 60601-1, ISO 9919, IEC 62304). For the oximeter, a "Clinical Dynamic Simulator Validation Report" by Masimo was used, implying that the simulator's output served as the ground truth for oximetry values.

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning or AI that would require a "training set" in the computational sense. The device's operation is based on programmed logic and physical mechanisms.

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

Not applicable, as there was no training set for an AI/ML algorithm.

Ask a specific question about this device