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Clearo is indicated for use on adult or pediatric patients unable to cough or clear secretions effectively. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. The device is intended to be used in the hospital, institutional environment or in the home.

The Breas Medical Clearo is an airway clearance device that provides Mechanical Insufflation-Exsufflation (MI-E) therapy. Clearo is indicated for use on adult or pediatric patients who are unable to cough or clear secretions effectively. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. The device is intended to be used in the hospital, institutional environment or in the home.

The Clearo device is not intended to be used in line with a ventilator.

Clearo must be prescribed by a licensed physician and must be used only as directed by a physician or healthcare provider.

Clearo must be used with a single-limb patient circuits fitted an anti-bacterial filter.

Clearo functions by delivering ambient air at a defined positive pressure to the patient's airways (insufflation), followed by a rapid shift to negative pressure (exsufflation). This quick transition—known as "time through zero" – creates a high expiratory flow that stimulates or simulates a natural cough.

Optional oscillatory vibrations may further aid in loosening and mobilizing secretions. The continued rapid transition to negative pressure helps generate sufficient expiratory flow from the central airways, supporting the clearance of respiratory secretions.

Clearo achieves its intended use through a blower, which compresses air, a solenoid-controlled valve to manage air flow and pressure, and microcontroller electronics to control and monitor the operation. Clearo is powered from either a mains source or an internal battery.

Clearo includes the following device modes to accommodate both clinical and patient use:

• Unlocked (Clinical) Mode: Provides full access to all treatment settings and mode configurations, intended for use by healthcare professionals. Clinicians can enable specific modes for patient use and customize treatment protocols.
• Locked (Patient) Mode: Restricts access to pre-selected modes as set by the clinician. Patients cannot modify treatment parameters but may view compliance data and alarm history.

Clearo provides the following Treatment Modes:

• Manual Mode: The user controls the cycling between insufflation and exsufflation via a manual switch. This mode supports "Insufflation Rise" to control pressure ramp-up. Sessions can be recorded and stored for repeated use using the Treat-Repeat feature.
• Basic Auto Mode: Provides repeated, automatic cycling of insufflation, pause, and exsufflation, with configurable recruitment breaths, pause intervals, rise time, and optional patient-triggered breaths. Optional Stepped Insufflation Breaths gradually increases insufflation pressure across breaths for comfort.
• Program Auto Mode: Similar to Basic Auto but with a customizable, repeatable sequence of multiple insufflations followed by one exsufflation. Includes all features of Basic Auto Mode.

This FDA 510(k) clearance letter and summary primarily focus on demonstrating substantial equivalence through technical comparisons and compliance with relevant standards rather than a typical clinical study with acceptance criteria and reported device performance metrics in a tabular format. The document emphasizes performance testing which verifies conformance with requirements, but these are primarily engineering-level tests, not direct clinical performance metrics.

Therefore, many of the requested points regarding sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for clinical data are not explicitly detailed in this provided text because the clearance relies on non-clinical performance and substantial equivalence to a predicate device.

However, I can extract and infer information about the acceptance criteria and study proving device meets them based on the provided text, focusing on the engineering and non-clinical aspects:

1. A table of acceptance criteria and the reported device performance:

Based on the provided text, the "acceptance criteria" discussed are primarily adherence to specified technical characteristics and performance within defined ranges, as well as compliance with various medical device standards. The "reported device performance" is framed as the device meeting these specifications and showing comparable waveforms to the predicate.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated as a number of patients or cases. The testing described is primarily non-clinical performance testing (e.g., pressure, flow, timing, oscillation measurements on the device itself, EMC, electrical safety) and waveform comparison against a predicate device.
• Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective study for clinical data, as this filing relies on engineering performance tests and comparative technological characteristics. It's safe to assume the testing was conducted in a laboratory/engineering environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not mentioned, as the "ground truth" for this submission are the engineering specifications, relevant IEC and ISO standards, and the performance of the predicate device (CoughAssist T70). Expert opinion on clinical efficacy/diagnosis is not the basis for this 510(k) clearance documentation.

4. Adjudication method for the test set:

• Not applicable/Not mentioned. Adjudication methods are typically associated with clinical studies involving reader-based interpretations (e.g., radiology images). This submission focuses on objective engineering measurements and compliance with 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, an MRMC comparative effectiveness study was not conducted or described. This type of study is relevant for AI/radiology devices where human interpretation is assisted by AI. The Clearo device is a therapeutic device (mechanical insufflation-exsufflation device), not an AI diagnostic imaging tool.

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

• Not applicable. This device is a mechanical medical device, not an AI algorithm. While it has software and microcontroller electronics, its "performance" is its mechanical function, regulated by its design parameters and confirmed through physical measurements and standard compliance.

7. The type of ground truth used:

• The "ground truth" for this submission is primarily:
  • Engineering Specifications and Design Requirements: The device's internal design parameters for pressure, flow, timing, oscillation, etc.
  • International Standards: Conformance to standards like IEC 60601 series, ISO 18562 series, etc., which define safety and performance benchmarks.
  • Predicate Device Performance: The established, legally marketed performance of the Respironics CoughAssist T70 provides the benchmark for "comparable waveforms" and technological characteristics.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a "training set" of data in the typical sense for algorithm development.

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

• Not applicable, as there is no "training set" as understood in the context of AI/machine learning.

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The BiWaze Clear System is indicated for the loosening and mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and can provide supplemental oxygen when used with an oxygen supply.

The BiWaze Clear System is for use on adult or pediatric patients in acute care (aged 2 years and older) and home care environments (aged 5 years and older).

The BiWaze Clear System may be used with patient interfaces including face mask, mouthpiece, a trach adapter to endotracheal or tracheostomy tube in acute and home care environments. The BiWaze Clear System may be used in-line with a ventilator in acute care environment only.

The BiWaze Clear System is identical to the BiWaze Clear System cleared under K213564. The present submission extends BiWaze Clear System claims to include use in-line with a ventilator in the acute care environment only.

The BiWaze Clear System assists patients in loosening and mobilizing secretions as well as treating and preventing atelectasis by providing lung expansion and high frequency oscillation therapies. The oscillating lung expansion therapy of the BiWaze Clear System is intended to reduce airway obstructions caused by secretions occupving the lower airways. prevent respiratory tract infections, re-expand the collapsed areas of the lung, thereby enhancing gas exchanges and reducing inflammatory response.

BiWaze Clear provides three respiratory therapies: PEP, OSC, and NEB.

• Positive Expiratory Pressure (PEP): During PEP, the system delivers a programmed . positive pressure which the patient exhales against to open and expand the patient's airways. The nebulizer can be configured to run during PEP therapy to help move the aerosolized saline solution throughout the airways.
• Oscillation (OSC): During OSC, the system oscillates the airways with pulses of . positive pressure to thin secretions and mobilizes them from the lower airways to the upper airways so they can be coughed or suctioned out. The nebulizer can be configured to run during OSC therapy to help move the aerosolized saline solution throughout the airways.
• . Nebulize (NEB): During NEB. the system powers only the Aerogen Solo vibrating mesh nebulizer. This therapy gives the patient a break from PEP or OSC while the patient receives their nebulized aerosolized saline.

The BiWaze Clear System provides a closed-circuit the Dual Lumen Breathing Circuit that prevents aerosolized exhalation of air from escaping the handset or breathing tube before being filtered by a coaxial bacterial/viral filter.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BiWaze Clear System.

Important Note: The provided document is a 510(k) summary for a medical device and describes its substantial equivalence to a predicate device, rather than providing a detailed clinical study with specific performance metrics against pre-defined acceptance criteria for a new AI/software diagnostic device. The "acceptance criteria" here refer to the criteria for demonstrating substantial equivalence for a non-continuous ventilator, and the "study" is primarily non-clinical bench testing. Therefore, many of the requested fields are not directly applicable or cannot be extracted from this type of document, particularly those related to AI algorithm performance, human readers, ground truth establishment, and sample sizes for training/test sets in an AI context.

Description of Acceptance Criteria and Supporting Study

The BiWaze Clear System (K231728) is a non-continuous ventilator. The acceptance criteria described in this 510(k) summary are centered around demonstrating substantial equivalence to a predicate device (Hill-Rom Volara™ System, K200988) and a reference device (BiWaze Clear System, K213564). This involves showing that the proposed device has similar indications for use, operating principles, technology, and performance, with a specific focus on extending its claims to include "use in-line with a ventilator in the acute care environment only."

The "study" that proves the device meets these acceptance criteria primarily consists of performance bench testing and adherence to various medical device standards.

1. A table of acceptance criteria and the reported device performance

• Specific extended claim: BiWaze Clear use in-line with ventilator is intended only in the acute care environment. |
  | Technology/Performance (Functionality, Safety, Effectiveness): | - Operating principle (Electro-Mechanical device, Air or Oxygen).
• Therapy Modes (PEP, OSC, NEB, with specified pressure/frequency limits).
• Patient Circuit Configurations (Disposable circuit with handset and in-line nebulizer connection).
• Patient Interface (Mouthpiece, Facemask, Trach Adapter, Ventilator Tee Adaptor).
• SpO2 Connection (Supports connection and displays SpO2 values and heart rate).
• Adherence to relevant medical device standards (e.g., IEC 60601 series, ISO 18562 series, ISO 10993-1, IEC 62304, ISO 14971). | - "Functionally, the performance and therapy mode functions are similar to the predicate device."
• "The proposed modifications are changes to the labelling with supporting data from testing without a change in device technology."
• "The core capabilities of the modified BiWaze Clear System remained unaltered compared to the predicate device."
• "The device modifications discussed do not alter the BiWaze Clear device's safety or effectiveness and neither do they change its indication for use compared to the predicate device."
• "Validated through non-clinical bench testing and determined to be substantially equivalent to the predicate."
• Biocompatibility: "no change in design and materials in the gas and fluid pathways are identical to the reference device, BiWaze Clear System (K213564)." |

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

This information is not provided in the document because it pertains to performance data typical for diagnostic AI devices, clinical studies, or usability studies involving human participants. The "test set" here refers to the actual physical device undergoing non-clinical bench testing, not a dataset in the AI sense.

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 and is not applicable for this type of device submission, which relies on engineering and performance standards rather than expert-established ground truth for diagnostic accuracy.

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

This information is not provided and is not applicable for this type of device submission. Adjudication methods are typically used in clinical studies or when establishing ground truth for AI algorithms, which is not the focus here.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, which is not what the BiWaze Clear System is.

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

This question is not applicable. The BiWaze Clear System is a physical medical device (ventilator) that the document clarifies has no change in underlying technology, but an extended use claim supported by bench testing. It does not employ a standalone AI algorithm in the context typically discussed for diagnostic or assistive AI software.

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

The "ground truth" for this submission is based on established engineering and performance standards for non-continuous ventilators, as well as the performance characteristics of the legally marketed predicate device (Volara™ System). The equivalence is demonstrated through non-clinical bench testing according to these standards, not against a clinical "ground truth" like pathology or outcomes data in the usual sense for a diagnostic device.

8. The sample size for the training set

This information is not provided and is not applicable. The device is not an AI/ML algorithm that requires a training set.

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

This information is not provided and is not applicable, as there is no training set for an AI/ML algorithm in this context.

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The BiWaze Clear System is indicated for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis and has the ability to provide supplemental oxygen supply.

The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 2 years in the acute care setting.

The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 5 years in the home care setting.

The BiWaze Clear System assists patients in loosening and mobilizing secretions as well as treating and preventing atelectasis by providing lung expansion and high frequency oscillation therapies. The oscillating lung expansion therapy of the BiWaze Clear System is intended to reduce airway obstructions caused by secretions occupying the lower airways, prevent respiratory tract infections, re-expand the collapsed areas of the lung, thereby enhancing gas exchanges and reducing inflammatory response.

BiWaze Clear provides three respiratory therapies: PEP. OSC. and NEB.

• Positive Expiratory Pressure (PEP): During PEP, the system delivers a programmed positive pressure which the patient exhales aqainst to open and expand the patient's airways. The nebulizer can be configured to run during PEP therapy to help move saline throughout the airways.
• Oscillation (OSC): During OSC, the system oscillates the airways with pulses of . positive pressure to thin secretions and mobilize them from the lower airways to the upper airways so they can be coughed or suctioned out. The nebulizer can be configured to run during OSC therapy to help move saline throughout the airways.
• Nebulize (NEB): During NEB, the system powers only the Aerogen Solo vibrating mesh . nebulizer. This therapy qives the patient a break from PEP or OSC while the patient receives nebulized saline.

The BiWaze Clear System can be used in coniunction with the various patient interfaces such as facemask, mouthpiece or a trach adapter which connects to a patient's endotracheal or tracheostomy tube. It is intended to deliver therapy to pediatric and adult patients in acute. post-acute, and home care settings.

The BiWaze Clear System provides a closed-circuit the Dual Lumen Breathing Circuit that prevents aerosolized exhale air from escaping the handset or breathing tube before being filtered by a coaxial bacterial/viral filter.

Here's a breakdown 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 does not explicitly present a table of acceptance criteria with corresponding performance metrics for each criterion against a specific threshold. Instead, it focuses on demonstrating substantial equivalence to a predicate device through various performance data and comparisons. The "acceptance criteria" are implied by the performance characteristics of the predicate device and the new device's ability to match or be comparable to them.

However, based on the text, we can infer the key areas of performance that were evaluated and for which the new device (BiWaze Clear System) was found to be "substantially equivalent" to the predicate (Volara™ System).

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

• Sample Size: The document does not specify a numerical "sample size" in terms of number of patient cases or units for the test set. The performance data is based on "bench testing" and "non-clinical testing." This implies laboratory-based tests on device units rather than patient data.
• Data Provenance: Not applicable in the context of patient data, as no clinical studies with human subjects were conducted or submitted. The testing was entirely non-clinical bench testing.

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

• This question is not applicable as there was no ground truth established by experts in the context of human physiological or pathological conditions. The "ground truth" for the device's performance was established by engineering and performance specifications and comparison to the predicate device's measured performance in a bench setting.

4. Adjudication Method for the Test Set

• This question is not applicable as there was no expert adjudication process due to the absence of clinical studies and human-based ground truth establishment. Performance was directly measured against specifications and predicate device behavior.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• This question is not applicable. The BiWaze Clear System is a mechanical therapeutic device (Noncontinuous Ventilator for secretion mobilization and lung expansion), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI assistance effect size is irrelevant to this device.

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

• This question is not applicable. The device is not an algorithm; it is a standalone mechanical medical device that performs therapies. Its performance is inherent to the device itself, not dependent on or enhanced by a human-in-the-loop interaction in the way AI algorithms are evaluated.

7. The Type of Ground Truth Used

• The ground truth used for demonstrating substantial equivalence was primarily engineering specifications, direct comparative measurements against a legally marketed predicate device (Volara™ System), and compliance with recognized industry standards (e.g., IEC 60601-1, ISO 10993-1). No expert consensus, pathology, or outcomes data from human patients were used.

8. The Sample Size for the Training Set

• This question is not applicable. The BiWaze Clear System is a physical device, not a machine learning model. Therefore, it does not have a "training set" in the context of AI.

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

• This question is not applicable for the same reason as point 8; there is no training set. Design and development would have been guided by engineering principles and existing medical knowledge of respiratory therapies.

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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 combines 2 main types of therapies referred to as:

• MIE (Mechanical Insufflation-Exsufflation) Synclara®
• OLE (Oscillation and Lung Expansion) - Volara™

The modification is to add the ability to provide aerosol from the nebulizer via the Ventilator Tee adaptor during Continuous High Frequency Oscillations (CHFO) mode when connected to a ventilator. All components were cleared under K192143.

The provided text describes a 510(k) premarket notification for the Maximus™ System, a noncontinuous ventilator. The submission is for a modification to an already cleared device (K192143) to add the ability to provide aerosol from the nebulizer via a Ventilator Tee adapter during Continuous High Frequency Oscillations (CHFO) mode when connected to a ventilator.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparative testing conducted, aiming to demonstrate equivalence to the predicate device. The performance metrics reported are related to aerosol delivery, specifically Mass Median Aerodynamic Diameter (MMAD), Total Respirable Dose, and Fine Particle. The acceptance criteria for these metrics were that they should be "equivalent" across different patient interfaces.

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

• Sample Size for Test Set: Not explicitly stated as a number of devices or clinical cases. The testing was described as "comparative particle characterization testing comparing the following patient interfaces: Mouthpiece, Face Mask (already cleared under K192143) and delivery through the already cleared Ventilator Tee Adaptor." It was performed at "Adult flow rates (28 Lpm) and Pediatric flow rates (12 Lpm) with 1 drug at the lowest and highest set pressures (5 and 70 cmH2O)." This indicates bench testing rather than patient data.
• Data Provenance: The data is from bench testing performed by the manufacturer, Hill-Rom Services Pte Ltd. There is no mention of country of origin for the data or if it was retrospective or prospective, as it is not human subject data.

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

Not applicable. The ground truth for this submission is based on objective measurements from bench testing of aerosol delivery parameters, not expert human assessment.

4. Adjudication Method for the Test Set

Not applicable, as the evaluation is based on objective measurements from bench testing.

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

No. This submission describes a modification to a medical device (ventilator) and involves bench testing of its physical performance (aerosol delivery), not a diagnostic algorithm or human interpretation task. Therefore, an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study

No. This is a physical device, and the testing focuses on its mechanical and delivery performance. There is no AI or algorithm involved in the direct clinical function being evaluated.

7. Type of Ground Truth Used

The ground truth is established through objective physical measurements of aerosol particle characteristics (MMAD, Total Respirable Dose, Fine Particle) using standardized test methods.

8. Sample Size for the Training Set

Not applicable. This device does not involve a machine learning algorithm that requires a training set.

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

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to establish for it.

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This device is designed for use on patients unable to cough or clear secretions effectively due to reduced peak cough exspiratory 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 or tracheostomy tube. For use in hospital, institutional setting, or at home. For use on adult patients 3 years old and up.

The BiWaze Cough is a device intended for clearing bronchopulmonary secretions. The therapy provided by BiWaze Cough mimics a cough and consists of three phases which mimic a cough; inhale, exhale, and pause phase. The inhale phase is positive airway pressure to expand the lungs. Then the exhale phase is a sudden shift to negative pressure to pull the air out of lungs. Finally, the pause phase provides positive pressure which keeps the airways open in between the therapy cycle. The Peak Inspiratory Flow can be selected on three different levels: High, Medium, Low. The device can be operated via a power supply and is also battery operated. Performance is controlled from a touch screen panel in manual or automatic modes. The device is controlled by software algorithms, and error messages are displayed in cases where the normal functioning doesn't occur. Advanced features include inspiratory trigger and oscillations.

The provided text does not contain information about acceptance criteria and the study proving a device meets these criteria in the context of an AI/Machine Learning device. Instead, it's a 510(k) summary for a medical device called "BiWaze Cough," which is a non-continuous ventilator.

The document discusses the device's substantial equivalence to predicate devices based on its technical characteristics, safety protocols, and performance data from bench testing and software code reviews, not from a clinical study involving human patients or ground truth established by experts.

Therefore, I cannot provide the requested information about acceptance criteria, test set sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for a machine learning model, as this information is not present in the provided text for this specific device.

The "Performance Data" section explicitly states: "Performance testing was conducted on BiWaze Cough and the device was found substantially equivalent to the predicate device. Verification activities have been performed to verify that the device modifications did not affect the safety and effectiveness of the subject device. This included bench testing, software unit testing, and code reviews." This confirms that the evaluation was engineering-based for a physical device, not an AI/ML model.

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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 MetaNeb® 4 System is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.

The MetaNeb® 4 System is a therapeutic device that uses a systematic approach to enhance normal mucus clearance and resolve or prevent patchy atelectasis. The system has three modes: Aerosol, CHFO (Continuous High Frequency Oscillation), and CPEP (Continuous Positive Expiratory Pressure). There are three major components: Circuit, Controller, and Stand.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria, structured according to your request:

Device Name: MetaNeb® 4 System

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices, particularly the MetaNeb® (K124032), rather than establishing new, specific performance acceptance criteria for the MetaNeb® 4 System itself. The acceptance criteria are implicitly met by showing the MetaNeb® 4 System performs equivalently or better than the identified predicates in key performance parameters.

The key performance comparisons are related to peak pressure in different therapy modes.

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

• Performance Comparison (Peak Pressure): The sample size for the bench tests is not explicitly stated as a numerical value (i.e., 'n'). The testing involved comparing the MetaNeb® 4 System to the MetaNeb® (K124032), PowerNeb (K051964), and IPV (K895485). The data provenance is generally "bench testing" performed by the manufacturer (Hill-Rom Services Pte Ltd). It's a prospective study of the device's physical performance characteristics.
• Usability Study: The sample size is referred to as "2 user groups: caregivers and lay users." The specific number of participants within each group is not provided in this summary. The data provenance is a usability study conducted to evaluate the device's use in the home environment, likely a prospective study. The country of origin of the data is not specified.

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

This type of information is not applicable to this submission. The "ground truth" for the performance tests (peak pressure) is the physical measurement of the device's output, compared against its own specifications and the previously cleared predicate devices' performance. For the usability study, the "ground truth" is the observation of user performance, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable as it typically refers to methods for resolving discrepancies in expert interpretations (e.g., in medical image analysis). For bench testing, direct measurement and data collection are used. For the usability study, observations of user performance were recorded, often with predefined criteria for success/failure, but an adjudication method for conflicting expert opinions is not mentioned because experts (in the sense of adjudicators) are not setting the "ground truth."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The MetaNeb® 4 System is a therapeutic medical device (non-continuous ventilator), not an AI/CAD (Computer-Aided Detection/Diagnosis) system. Therefore, MRMC studies and AI-assisted improvements for human readers are not relevant.

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

This information is not applicable. The MetaNeb® 4 System is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• Performance Comparison (Peak Pressure): The ground truth is established through physical measurements and engineering specifications of the device's output in various modes, compared to the previously established performance of predicate devices. This falls under bench testing data.
• Usability Study: The ground truth is established through direct observation of user performance in conducting critical tasks with the device in a simulated environment. This is a form of empirical user performance data.

8. The Sample Size for the Training Set

This information is not applicable. Since this is a physical medical device (MetaNeb® 4 System) and its development involved engineering design and validation against performance specifications and predicate devices, there isn't a "training set" in the context of machine learning or AI.

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

This information is not applicable for the reasons stated above (not an AI/ML device). Engineering validation and design controls are used during device development, which are different from establishing ground truth for a "training set" in AI.

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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 Vital Cough is intended 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 device is an electromechanical software controlled device housed in a metal and polymer case. A touch screen displays outputs and receives commands from the user. The device develops positive and negative pressure through an adjustable blower. In inhale mode the lungs are inflated. The device rapidly shifts to providing negative pressure with the intended goal of rapidly deflating the lungs to stimulate an effective patient cough. A flutter feature developed by an oscillator butterfly valve may be activated during exhalation to assist in loosening and removing secretions.

Here's a breakdown of the acceptance criteria and the study information for the Vital Cough device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for the Vital Cough with flutter feature are implicitly established through substantial equivalence claims to two predicate devices: the Vital Cough without a flutter feature (K120277) and the Acapella flutter device (K002768). The study aims to demonstrate that the new device's performance, particularly with the added flutter feature, is comparable and safe for its intended use.

Explicit Performance Characteristics and Comparison:

Summary of Device Meeting Acceptance Criteria:

The Vital Cough with flutter demonstrates substantial equivalence primarily by matching or exceeding the performance characteristics of its predicate devices where applicable.

• Pressure and Flutter Characteristics: It achieves the same maximum positive/negative pressures as the original Vital Cough (K120277) and offers a comparable flutter frequency range and waveform technology to the Acapella (K002768).
• Fundamental Functionality: The core MI/E (Mechanical Insufflation-Exsufflation) design is present in both the new device and the predicate Vital Cough. The added flutter feature is directly compared to the Acapella.
• Indications for Use: The new device maintains the same broad indications for use as the original Vital Cough, which covers a wider patient population and method of use than the Acapella.
• Operating Modes and Settings: It shares the same microprocessor-controlled automatic and manual modes, and adjustable time intervals as the original Vital Cough.

The submission specifically highlights that "The Vital Cough with flutter is substantially equivalent to the Vital Cough cleared device cleared under K120277 based on intended use, comparative testing, frequency and waveform. The MIE design is in both devices. The added flutter feature has the same indication for use to clear secretions as the original Vital Cough and the Acapella. The pressure and flow differences are due to the Vital Cough MI/E activity. The flutter activity is substantially equivalent. The Vital Cough with flutter is a mechanical device driven by a fan. The Acapella is driven by himan effort. The Vital Cough device does the work for the patient."

Study Information

The 510(k) summary provided does not describe a clinical study involving human subjects or a large-scale data analysis (like an AI study). Instead, it relies on non-clinical testing to demonstrate substantial equivalence.

1. Sample size used for the test set and the data provenance: Not applicable. The documentation refers to "comparative testing" and "waveform characterization and analysis" between the new device and the predicate devices, implying bench testing and engineering comparisons rather than a human-subject test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic AI or clinical studies, is not established here. The comparison is against established technical specifications and performance characteristics of predicate devices.
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. This is not an AI-assisted diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an electromechanical device, not a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for comparison is the published technical specifications, performance data, and established intended uses of the predicate devices (Vital Cough K120277 and Acapella K002768). For non-clinical testing, this would involve laboratory measurements against those specifications.
7. The sample size for the training set: Not applicable. This device does not use machine learning or AI algorithms requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Non-Clinical Testing Details Provided:

The summary states the following non-clinical testing was conducted:

• Compliance with IEC 60601-1 (general requirements for electrical safety).
• Compliance with IEC 60601-1-2 (electromagnetic compatibility standards).
• Verification that no toxic substances were found in the output air.
• Conformity to ISO 9703 (anesthesia and respiratory care alarm signals, auditory and visual).
• Characterization by pressure and flow of the Acapella predicate and the Vital Cough with flutter feature. This is the core of the performance comparison for substantial equivalence.

In essence, the study focuses on engineering and safety testing to demonstrate that the new device, with its added flutter feature, is functionally equivalent and safe compared to already legally marketed devices, primarily the original Vital Cough and the Acapella.

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