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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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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 Monarch™ product is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging.

The Monarch™ Airway Clearance System is intended to be used in the Home Care environment by patients, 15 years and older.

The Monarch™ Airway Clearance System consists of a garment which contains actuators together with the Main Control Box and pendant controller. The Main control box contains the electronics used to control the actuators which are organized into 8 discrete zones. The pendant controller is tethered to the garment and consists of a LCD display and selection controls to facilitate visual feedback of the therapy and system information while allowing the user to adjust the therapy settings to adhere to the prescribed therapy ordered by the physician.

It has adjustment mechanisms over each shoulder and on each side of the mid chest area to provide the wearer with a personal and evenly distributed snug fit. The buckles on each side of the device together with the front zipper help provide a repeatable fitting by allowing the wearer to wear and remove the garment without making changes to the adjustment mechanisms. The product also includes an external charger for the battery and can run on either power source as per desired by the user.

The major components to the Monarch™ Airway Clearance System are:

• Garment which contains the "pods" .
• . Garment shell - covers the underlying the garment
• . Pendant – controls the device function
• . Battery - installed in the backpack cover
• Garment adjustment mechanisms means to secure and adjust the fit of the Garment to the . user

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance for the Monarch™ Airway Clearance System:

It's important to note that the provided document is a 510(k) Summary, which aims to demonstrate substantial equivalence to a predicate device rather than providing a detailed clinical trial report or a comprehensive standalone performance study. Therefore, some information typically found in a full study report (like the exact statistical methods used for comparison or detailed effect sizes for human-in-the-loop studies) might not be present or explicitly stated.

Acceptance Criteria and Reported Device Performance

The document describes the device's performance in comparison to predicate and reference devices, rather than against specific, pre-defined quantitative acceptance criteria in a strict sense. The "acceptance criteria" appear to be based on the concept of "substantial equivalence" to the identified predicate devices, particularly regarding performance parameters.

Table of Acceptance Criteria (as inferred from the "Discussion of Substantial Equivalence" and "Bench Testing" sections):

Specific parameters cited:

• Peak Force (N): 2.2 to 25.9 (Monarch™)
  • Predicate (Vest Model 105): 3.1 to 31.7
  • Reference (AffloVest): 4.9 to 9.5
    (Monarch™ falls largely within or near the range of the predicate and reference, consistent with the objective.)
• Acoustic energy: 43.6 dBA @ 0.3 m (Monarch™)
  • Predicate (Vest Model 105): 82.8 dBA @ 1 m
  • Reference (AffloVest): 48 dBA @ 1 m
    (Monarch™ appears quieter than both, which is typically a positive attribute.)
• Weight of worn components: 6.0 kg (Monarch™)
  • Predicate (Vest Model 105): 1.0 kg
  • Reference (AffloVest): 5.4 kg
    (Monarch™ is heavier than the predicate but comparable to the reference.)
• Durability: Garment cover durability to cleaning tested (5 years/60 cycles).
• Simulated Life Cycle Testing: Performed.
• Usability: Demonstrated for home environment. |
  | Biocompatibility: No direct patient contact, similar to predicate/reference. | No direct patient contact; user wears an undergarment. Similar to predicate and reference devices. |
  | Electrical Safety: Compliance with relevant standards. | Complies with ES 60601-1, CAN/CSA C22.2 No. 60601-1, IEC 60601-1-2, IEC 60601-1-11. |
  | Operating/Environmental Conditions: Within acceptable ranges for operation and storage. | Operating: Temp 41-95°F, Humidity 15-90%, Pressure 70-106 kPa. Environmental: Temp -4-140°F, Humidity 15-90%, Pressure 50-106 kPa. These ranges are comparable to or within the ranges of the predicate and reference devices. |

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • The document describes "Non-clinical Bench Testing" and "Human Factors / Usability Testing."
   • Bench Testing: No specific numerical sample sizes (e.g., number of garments, number of tests run) are provided for the bench tests (Peak Force, Durability, Simulated Life Cycle). The "test set" here refers to measurements taken on the device itself under various conditions (different chest locations on a mannequin, frequencies, intensity levels).
   • Human Factors / Usability Testing: The test included "individuals representing two distinct user groups." The exact number of participants is not specified.
   • Data Provenance: Not explicitly stated for bench testing, but typically performed in a controlled lab environment. Human Factors testing would involve human participants (countries not specified, but the applicant company is Hill-Rom Services Pte Ltd, Singapore, with a US consultant, so testing could have occurred in Singapore or the US). The document implies these were prospective tests performed to support the 510(k) submission.

2. 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):

   • For this type of device (Powered Percussor), the "ground truth" is primarily based on engineering specifications and comparative physical performance measurements rather than expert interpretation of medical images or conditions.
   • For the Human Factors / Usability testing, the "ground truth" is whether users can safely and effectively interact with the device. This is established by observing representative users. The document doesn't specify the number or qualifications of experts involved in the observation or assessment of usability, but usually, human factors specialists are involved.

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

   • Not applicable in the context of physical performance testing of a device or usability testing. Adjudication methods like '2+1' (two readers agree, third is tie-breaker) are common in diagnostic imaging studies where subjective interpretation is key. Here, the "truth" is either a measured physical parameter or an observed behavior.

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:

   • No, an MRMC comparative effectiveness study was not done. This device is a therapeutic medical device (airway clearance system), not an AI-powered diagnostic imaging tool. Therefore, a study comparing human readers with and without AI assistance is not relevant to this product. The evaluation focuses on the physical performance of the device and its usability.

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

   • Yes, in spirit, standalone performance was assessed for the physical device. The "Non-clinical Comparative Performance" bench testing section describes tests of the device's physical output (Peak Force, Durability, Life Cycle) operating on its own (or with a mannequin) without continuous human-in-the-loop real-time control other than setting parameters.

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

   • The "ground truth" for the performance evaluation relied on:
     • Physical measurements/benchtop data: Quantifiable output (peak force, acoustic energy, weight) directly measured from the device.
     • Engineering specifications/standards: Compliance with electrical safety (IEC 60601-1 series).
     • Comparative data: The performance of the predicate and reference devices served as the comparative "truth" against which the new device was evaluated for substantial equivalence.
     • Observed user interaction/usability: For the human factors testing, the ability of users to successfully perform tasks with the device.

7. The sample size for the training set:

   • Not applicable. This document describes the testing and comparison of a physical medical device, not an AI/ML algorithm that requires a "training set." The device's control system is likely based on traditional embedded software and hardware logic, not a machine learning model that learns from data.

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

   • Not applicable, as there is no "training set" for this type of device.

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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 MetaNeb® 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® 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 MetaNeb® System (K124032) based on the provided 510(k) summary, structured to address your specific points:

Since this is a 510(k) submission for a non-continuous ventilator, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to predicate devices, rather than meeting specific quantifiable performance targets like sensitivity or specificity for an AI device. The study performed is a "comparative effectiveness study" in the sense of comparing the new device's performance to the predicate devices through various bench tests.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MetaNeb® System are implicitly derived from demonstrating substantial equivalence to its predicate devices (PowerNeb® CoMedica K051964 and IPV - Percussionaire Corp K895485). This means the device must perform comparably in its intended use, safety, and effectiveness.

Table 1: Acceptance Criteria (as demonstrated by substantial equivalence to predicates) and Reported Device Performance

Study Details Proving Acceptance Criteria:

The submission relies on a series of non-clinical bench tests to demonstrate substantial equivalence, rather than human clinical trials.

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a "sample size" in the context of patients. The "test set" consists of mechanical/bench testing of the device and its components. The specific number of devices or components tested for each experiment (e.g., how many circuits were tested for particulate characterization, or how many full systems for life cycle testing) is not detailed.
   • Data Provenance: Retrospective, as it involves laboratory testing conducted by the manufacturer to support the 510(k) submission. Country of origin for the data is assumed to be Singapore where Hill-Rom Services Pte Ltd is located, or at a contracted testing facility.

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

   • Not Applicable. For a device performance bench test comparing against predicate devices, "ground truth" is established by validated testing methodologies and standards (e.g., aerosol particle sizing, pressure measurements) and comparison against the specifications/performance of legally marketed predicate devices. It doesn't involve expert consensus on medical images or clinical outcomes. The experts involved would be engineers and technical specialists conducting and analyzing the tests.

3. Adjudication method for the test set:

   • Not Applicable. As this is bench testing for substantial equivalence, clinical adjudication by medical experts isn't part of the process. Test results are compared directly against established engineering parameters, predicate device specifications, and relevant standards (e.g., ISO 10993-1).

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:

   • No. This is not an AI-powered diagnostic device, so a MRMC study is not relevant or applicable.

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

   • Yes, in essence. The "standalone performance" is represented by the non-clinical bench testing where the device's technical specifications and performance characteristics (e.g., pressure output, aerosol particle size, frequency of oscillation) are measured directly and compared against the established performance ranges of the predicate devices under controlled laboratory conditions, without human interaction beyond initiating the test.

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

   • Technical Specifications and Predicate Device Performance. The "ground truth" for this submission is based on:
     • Validated engineering and physics principles (e.g., how pressure is measured, how aerosol particles are characterized).
     • Internationally recognized standards (e.g., ISO 10993-1 for biocompatibility).
     • The established and cleared performance characteristics of the legally marketed predicate devices.

7. The sample size for the training set:

   • Not Applicable. This is a hardware medical device, not an AI/machine learning algorithm requiring a "training set."

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

   • Not Applicable. As there is no training set for an AI algorithm. The device's design and engineering are based on established pneumatic principles and medical needs for respiratory therapy.

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