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The Maximus™ System provides features of both the Synclara™ System and the Volara™ System.

The Maximus™ System, when used as a Synclara™ Cough System is intended for use on patients who are unable to cough or clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness.

The Maximus™ System, when used as a Volara™ System is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with oxygen supply.

The Maximus™ System is a 2 in 1 device which is a combination of two (2) already cleared devices. The Maximus™ System provides the individual therapies of the predicates: Vital Cough and MetaNeb®. The Maximus™ can be programmed to allow the user to provide both therapies or one only. The 2 main types of therapies are referred to as:

• . MIE (Mechanical Insufflation-Exsufflation)
• OLE (Oscillation and Lung Expansion) ●

The provided text is a 510(k) premarket notification for the Maximus™ System, a medical device for respiratory therapy. It outlines the device's indications for use and compares it to predicate devices to establish substantial equivalence with respect to safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a formal "acceptance criteria" table with numerical targets, as is common for diagnostic accuracy studies. Instead, it argues for substantial equivalence to predicate devices. This means the primary acceptance criterion is that the Maximus™ System performs functionally and safely similar to its predicates (MetaNeb® and Vital Cough) and does not raise new or different questions of safety or effectiveness.

The comparison tables (Table 1, Table 2, Table 3 – although some are presented partially) serve as the 'reported device performance' against the implicit acceptance criterion of equivalence to the predicates.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes bench testing and comparative performance testing against predicate devices and reference devices. It does not refer to clinical studies with patient test sets in the context of diagnostic accuracy. Therefore, details regarding "sample size for the test set" or "data provenance (country of origin, retrospective/prospective)" for patient data are not applicable to this 510(k) submission, which focuses on substantial equivalence based on performance and safety characteristics compared to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. As this is a medical device submitting for substantial equivalence based on engineering and performance criteria rather than diagnostic accuracy with a ground truth established by experts, this type of detail is not expected or relevant in this context. The "ground truth" here is the established safe and effective operation of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no human adjudication of a "test set" in the context of diagnostic performance as described in the document.

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. The Maximus™ System is a therapeutic device (noncontinuous ventilator), not a diagnostic AI system that "assists human readers." Therefore, an MRMC comparative effectiveness study is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The Maximus™ System is a physical electro-mechanical device that delivers therapy, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this 510(k) submission for substantial equivalence is the established safe and effective performance of the predicate devices (Hill-Rom MetaNeb® and Vital Cough), as well as reference devices (Bird IPV and Philips Respironics Cough Assist T70) for specific performance parameters. The device's performance is compared against these established benchmarks through various bench tests.

8. The sample size for the training set

Not applicable. The document describes a physical medical device, not a machine learning model that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no machine learning model or "training set," this question is not relevant.

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The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non-invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications.

The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively.

The VOCSN unified respiratory support system is a mechanical ventilator which combines additional conventional therapies into a single device. Additional therapies include oxygen, cough assist, and suction.

The device description will be broken down by therapy; i.e., ventilation, oxygen concentration and delivery, cough assist, and suction.

The provided text describes a medical device, the VOCSN Unified Respiratory System, and its various components, along with comparisons to predicate devices and adherence to performance standards. However, it does not describe a study involving an AI algorithm's performance or human reader improvements. Therefore, I cannot provide details on sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC studies, as these elements are not present in the document.

Instead, the document focuses on the VOCSN Unified Respiratory System's regulatory submission (510(k)) to the FDA, demonstrating its substantial equivalence to previously cleared medical devices. This involves non-clinical performance testing against user and product requirements and compliance with international standards.

I will structure the answer based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance (as derived from the text):

The acceptance criteria are generally framed as compliance with specific international and FDA guidance standards, as well as meeting internal User Requirements and Product Requirements Specifications. The "reported device performance" is essentially the statement that the device is compliant with these standards and requirements, and that verification/validation testing was successfully completed. Specific quantitative performance targets are not always explicitly stated in the summary but are implied by compliance with the referenced standards.

Ventilation Component:

Oxygen Concentrator Component:

Cough Assist Component:

Suction Component:

Heated Wire Patient Circuit Accessory:

Bacteria Filter Accessory:

Regarding AI-specific questions:

The provided document describes a physical medical device (VOCSN Unified Respiratory System), not an AI algorithm. Therefore, the following information is not present in the text:

2. Sample size used for the test set and the data provenance: Not applicable as no AI test set is described. The device performance was validated and verified through simulated use conditions and testing against various standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Device validation and verification typically involve engineering and clinical experts during the design and testing phases, but not specifically for establishing "ground truth" in the context of an AI model's performance.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is relevant for AI-assisted human reading tasks, which is not the subject of this document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable. The "ground truth" here is compliance with engineering specifications and regulatory standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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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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