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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.

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The MINI 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 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 MINI 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. 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 MINI 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 Mini 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 Mini 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 Mini Pegaso Cough. It can be used with a facemask or, with an adapter, to an endotracheal or tracheostomy tube. The Mini 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, Mini Pegaso Cough (without options), Mini Pegaso A-Cough (with the trigger option), Mini Pegaso A-Cough Perc (with trigger and percussion options) identification names will be used. Mini Pegaso Cough, Mini Pegaso A-Cough, Mini 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.

This document describes the Dima Italia Srl Mini Pegaso Cough, Mini Pegaso A-Cough, and Mini Pegaso A-Cough Perc devices, which are secretion clearance devices. The information provided is primarily focused on demonstrating substantial equivalence to existing predicate devices for FDA 510(k) clearance.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like a typical clinical study would. Instead, it describes "product requirements" and various types of testing to verify that the device meets "specifications." The closest it comes to a direct comparison of performance is in the "Technological Characteristics" table (pages 11-12) which compares the Mini Pegaso Cough's specifications to those of predicate devices.

Interpretation for Acceptance Criteria: The "acceptance criteria" here are implicitly the device's design input specifications and its ability to achieve performance comparable to predicate devices within those defined parameters.

Reported Device Performance (Excerpted from "Technological Characteristics" and "Performance Data" sections):

Study Proving Acceptance Criteria:
The document states that the devices were proven to meet these criteria through non-clinical testing, specifically:

• Bench testing: including black-box and white-box testing.
• Software unit testing.
• Hardware unit testing (for SpO2 introduction).
• Code reviews.
• Clinical Dynamic Simulator Validation Report (specifically for oximeter verification, run by Masimo).

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

• Test Set Sample Size: The document does not specify a numerical sample size for the test set. It refers to "patient case simulations" for AutoSync/EasyStart verification and "extreme therapy settings" for percussion testing, suggesting a range of conditions were tested on a bench/simulator, but no number of individual "cases" or "samples" is given.
• Data Provenance: The data provenance is from non-clinical bench testing and simulations, conducted by the manufacturer, Dima Italia Srl, and Masimo for oximeter verification. It is not patient data; therefore, there is no country of origin or retrospective/prospective designation in the human health context.

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

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document.

Given that the testing involved non-clinical bench testing and simulations, the "ground truth" would be established by the expected outputs/measurements based on the device's design specifications and engineering principles, rather than expert clinical consensus on actual patient data.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method like 2+1 or 3+1, which are typically used for disagreements among human experts evaluating clinical data. Since the testing was non-clinical and primarily bench-based, such a method would not be applicable. Device performance was assessed against predefined technical specifications.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states that "non-clinical tests" were used for validation, and only mentions a "clinical dynamic simulator" for pulse oximetry. There is no mention of human readers, clinical cases, or AI assistance for human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This question is not directly applicable in the context of this device. The Mini Pegaso Cough is a medical device, not an AI algorithm. Its "standalone" performance refers to its ability to operate according to its specifications during bench testing, which was done (e.g., "black-box performance testing," "white-box testing"). The device's operation is essentially "algorithm only" in the sense that it functions based on its programmed logic and hardware, without requiring human intervention for its core function during a therapy cycle, though it is human-operated.

7. Type of Ground Truth Used

The ground truth used was primarily engineering specifications and expected physical measurements/outputs based on the device's design. This includes:

• Expected pressure values (e.g., 0 to 50 cmH2O).
• Expected flow characteristics (Low, medium, High, Peak).
• Correct operation of modes (Manual, Auto).
• Accurate display of therapy parameters.
• Correct triggering performance for AutoSync/EasyStart.
• Accurate percussion frequency and waveform on a lung simulator.
• Proper data management functionality.
• Accurate pulse oximetry data visualization and alarm activation as verified by a clinical dynamic simulator.
• Compliance with various electrical safety, biocompatibility, and risk management international standards (e.g., IEC 60601-1, ISO 10993-1, ISO 9919).

8. Sample Size for the Training Set

This information is not applicable and not provided. This device is a hardware-based medical device with integrated software, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The software development process likely involved various levels of testing and verification, but not "training" using a specific dataset like an AI model.

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

This information is not applicable and not provided for the same reasons mentioned in point 8.

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The New Negavent Ventilator DA-3 Plus Pegaso V is a timed-cycled, pressure ventilator that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient. The ventilator works with a cuirass, poncho, or a ventilating chamber (Porta-Lung).

The Pegaso V is an assisted/controlled non-invasive ventilation system. It can work with a cuirass, poncho, or a ventilating chamber (Porta-Lung). An optional Trigger can be installed, sensing the spontaneous demands of the patient and permitting the use in Synchro/Timed, Spontaneous/Timed and Spontaneous with Plateau modes. If the Triggers are installed, the Autoparameters Function is enabled too, permitting the evaluation of the Respiratory Frequency and I/E Ratio of the patient in automatic mode. The negative pressure ventilation is a mechanical kind of ventilation similar to the human spontaneous ventilation. The Pegaso V is designed around 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 the atmosphere, compresses it in order to generate a pressure/depressure controlled by electronic sensors. Leaks are compensated cycle by cycle. 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 compressed flow go toward the patient and the depressed flow toward the atmosphere or, instead, the compressed flow to the atmosphere and the depressed flow toward the patient. The working parameters are displayed on an LCD and controlled through a touch keyboard.

The provided text describes a 510(k) premarket notification for the Pegaso V ventilator, asserting its substantial equivalence to a predicate device, the Lifecare NEV-100. The document primarily focuses on demonstrating this equivalence through a comparison of features, technical specifications, and safety standards, rather than detailing a specific study designed to meet quantitative acceptance criteria for device performance.

Therefore, many of the requested details about acceptance criteria, study sample sizes, ground truth establishment, and expert involvement are not explicitly stated in this document. The "acceptance criteria" appear to be satisfied by demonstrating substantial equivalence to the predicate device and meeting relevant electrical and safety standards.

Here's an attempt to extract and infer the information based on the provided text:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" are implied to be meeting various safety standards and demonstrating comparable performance parameters to the predicate device. The device performance is reported through a comparison table.

Study Details

The provided document is a 510(k) summary, which is a premarket notification for a medical device. It aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than providing detailed results of a clinical study or a standalone performance study as might be expected for an AI/CADe device.

As such, for many of the requested points, the answer is "Not applicable" or "Not provided in this document" within the context of a typical AI/CADe diagnostic device performance study.

1. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a performance study with a test set of patient data. The "test" here refers to demonstrating compliance with engineering and safety standards, and comparing technical specifications to a predicate device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in the context of diagnostic interpretation is described. The "truth" is established by engineering specifications and compliance with standards.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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: Not applicable. The device is a ventilator, not a diagnostic imaging aid.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Its performance is evaluated against engineering specifications and predicate device characteristics, not clinical algorithm performance.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" or basis for evaluation is the engineering specifications of the device, its function, and compliance with recognized safety and performance standards (IEC, EN standards). For substantial equivalence, the "ground truth" is the established characteristics and safety profile of the predicate device.
7. The sample size for the training set: Not applicable. The device is a hardware ventilator, not an AI model requiring a training set of data.
8. How the ground truth for the training set was established: Not applicable.

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For 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 a hospital, institutional setting, or home use given adequate training. For use on adult or pediatric patients.

The Pegaso Cough Assist is a negative pressure, non-invasive ventilation system useful in clearing retained bronchopulmonary secretions. It produces a patient "cough" simulation, applying a positive pressure to the airway, then rapidly going to a negative pressure. At the end of this pressure shifting, the Pegaso Cough leaves the airway free, at zero pressure, for a pause time determined by the operator. The Peak Inspiratory Flow can be selected on three different levels: High, Medium, Low.

This "forced insufflation-exsufflation" is designated for patients with reduced coughing possibilities due to muscular dystrophy, myasthenia gravis, poliomyelitis, and respiratory muscle paralysis such as spinal cord injury. Even patients with other diseases, such as emphysema and cystic fibrosis, can be treated with the Pegaso Cough. It may be used with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. The Pegaso Cough is indicated for use in a hospital, institutional setting, or home use given adequate training.

The Cough Assist device applies a positive pressure in the airway initially. The device shifts to a negative pressure through a facemask, mouthpiece, or an adapter to the patient's endotracheal tube or tracheostomy tube. The rapid shift produces a high expiratory flow from the lungs simulating a cough and clearing secretions. At the end of this pressure shifting, the Pegaso Cough leaves the airway free at zero or ambient pressure. A pause time between cycles is operator selected.

FDA classifies this device as a noncontinuous ventilator under 868.5905. Product Code NHJ under the Anesthesiology Review Panel. The device meets the requirements for medical equipment general requirements for basic and essential safety performance and electromagnetic compatibility.

The Pegaso Cough is comparable to the Emerson Cough Assist cleared under K002598 and have the similar indications for use.

The device is software controlled and has safety alarms for no pressure, high pressure, valve fault, low pressure, and power failure. Performance is controlled from a touch screen keyboard in manual or automatic modes.

This 510(k) summary describes the Pegaso Cough device and its substantial equivalence to the Emerson Cough Assist. It primarily focuses on comparing specifications and features rather than reporting on a specific study designed to meet acceptance criteria through device performance metrics.

Therefore, many of the requested sections (e.g., sample size, data provenance, ground truth establishment, MRMC study, standalone performance) cannot be fully populated as the document provided does not contain a detailed performance study with quantitative results against acceptance criteria.

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" with numerical targets for device performance in the form of a study. Instead, substantial equivalence is claimed based on comparable features and meeting general safety and ventilator standards. The performance metrics are presented as device specifications.

2. Sample sized used for the test set and the data provenance
The document does not describe a clinical performance study with a test set. This 510(k) relies on comparing device specifications and meeting recognized standards, rather than clinical data from a human test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring ground truth establishment by experts is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication is described.

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
Not applicable. This device is not an AI-assisted diagnostic device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device for physical therapy, not an algorithm. Its performance is inherent to its mechanical and electrical specifications and functionality. The document implies that the device performs its intended function based on its design and compliance with safety standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable for device performance comparison. The "ground truth" for demonstrating substantial equivalence is the predicate device's established performance and the general safety and ventilator standards (IEC 60601 series, EN 794-1 and -2).

8. The sample size for the training set
Not applicable, as no machine learning algorithm development (which would require a training set) is described.

9. How the ground truth for the training set was established
Not applicable, as no machine learning algorithm development is described.

Study Proving Device Meets Acceptance Criteria:

The provided document does not describe a specific clinical study with defined acceptance criteria and corresponding performance metrics demonstrating safety and effectiveness. Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Emerson Cough Assist, Model CA-3000, K002598) and compliance with recognized safety and performance standards.

The "study" for this 510(k) is essentially a comparison of technical specifications, intended use, and adherence to regulatory standards.

Key aspects of this demonstration include:

• Comparison Table: A detailed comparison table ([{3}]) outlines the similarities and differences between the Pegaso Cough and the predicate device across various features, including pressure ranges, modes of operation, timing control, power supply, and safety features.
• Statements of Similarities and Differences: The document explicitly lists 11 similarities and 4 differences to highlight the comparable nature of the devices ([{5}]). The differences (e.g., higher max pressure, wider timing range, lighter weight, software control) are presented as not raising new questions of safety or effectiveness.
• Standards Met: The Pegaso Cough is stated to meet a range of international and European standards, including IEC 60601-1 (Medical Equipment), IEC 60601-1-4 (Programmable Electrical Medical Systems), EN ISO 9703-3 (Alarm Signals), EN 60601-1-2 (Electromagnetic Compatibility), and EN 794-1 and -2 (Lung Ventilator) ([{2}]). These standards serve as proxies for demonstrating basic safety and performance "acceptance criteria."

The FDA's letter of clearance ([{6}]-[{7}]) confirms that based on the provided information, the device is deemed "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market under general controls. This determination itself serves as the "proof" that the device meets the implied regulatory acceptance criteria for market authorization via the 510(k) pathway, specifically by demonstrating equivalence to a predicate.

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