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The SIMEOX 200 airway clearance device is intended to promote airway clearance and to improve bronchial drainage by enhancing mobilization of bronchial secretions via high frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation. The device is intended to be prescribed for use in patients capable of independently generating cough.

SIMEOX 200 is intended for use in the home, hospital, and other healthcare institutions by individuals weighing at least 23 Kg.

The SIMEOX 200 Airway Clearance Device consists of a portable generator and a single patient use expiratory kit. The patient inhales from the ambient environment, naturally and independent of the device, and then exhales into the device mouthpiece. During the patient's exhalation, the SIMEOX 200 generates a pneumatic vibration throughout the airway. This vibration, applied at 6 Hz or 12 Hz via negative pressure pulses, disseminates throughout the bronchial tree in order to decrease mucus viscosity and increase secretion mobility. During or after therapy, the patient can clear the secretions by coughing independently.

This document describes the FDA's 510(k) clearance for the SIMEOX 200 Airway Clearance Device. It primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and non-clinical performance testing.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of human-in-the-loop performance, AI assistance, or expert-based ground truth establishment for diagnostic purposes.

The document states:

• "Performance verification testing was conducted on the bench with the SIMEOX 200 Airway Clearance Device to demonstrate the subject device performs to its pre-specified requirement specifications, which align with those of the predicate devices."
• "The SIMEOX 200 device also went through comprehensive software verification and validation testing to confirm the device operates within specification."
• "Testing demonstrated the SIMEOX 200 performed as intended and was safe and effective."
• "A human factors validation study was conducted with simulated first-time use of the product in adult users and dyads of children with caregivers. The study concluded that the device is safe for its intended users."

This indicates that the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and safety performance specifications, rather than clinical performance metrics typically associated with AI/diagnostic devices (like sensitivity, specificity, or reader improvement).

Therefore, I cannot populate the requested table and study details as they are not present in the provided text. The document describes a medical device (Airway Clearance Device), not an AI or diagnostic device that would typically involve the type of acceptance criteria and studies you've outlined.

The acceptance criteria implied are the device's ability to meet its pre-specified parameters (e.g., pressure range, oscillation frequencies) and demonstration of safety and effectiveness through bench testing, software validation, and human factors validation.

Here's a summary of the information that is available, reframing it in the context of device performance rather than AI/diagnostic performance:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information, it is largely not applicable or not provided for this type of device and submission:

2. Sample size used for the test set and the data provenance:
* Test Set: Not explicitly stated in terms of a "test set" for performance metrics like sensitivity/specificity. Performance testing was "on the bench" and included software V&V and human factors simulation.
* Data Provenance: Not applicable for this type of technical/safety validation. The human factors study involved "simulated first-time use," but details about participant numbers or demographic provenance are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This is not relevant for this device's 510(k) submission, as it's not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable.

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, as this is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable, as this is not an AI/algorithm-driven device in the sense of image analysis or diagnostic prediction. Its "performance" is based on its physical and software operation parameters.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* "Ground truth" in this context refers to the pre-defined engineering specifications and safety standards (e.g., pressure measurements, frequency measurements against a calibrated standard, successful execution of software functions, successful completion of simulated tasks in human factors). It's not a clinical or diagnostic ground truth.

8. The sample size for the training set:
* Not applicable. This device does not use machine learning that requires a "training set."

9. How the ground truth for the training set was established:
* Not applicable.

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The LibAirty Airway Clearance System is intended to provide airway clearance therapy and promote bronchial drainage when 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 LibAirty Airway Clearance System is intended for hospital, home, and clinic use.

The LibAirty Airway Clearance System is designed to assist in the loosening and elimination of mucus from the lungs. It consists of a vest with inflatable chambers, connected to a control unit (equipped with an air compressor) that inflates and deflates the vest in a pre-defined cycle, and a mobile application.

The LibAirty Airway Clearance System was designed to provide airway clearance therapy when external manipulation of the thorax is the physician's choice or treatment, while using an inflatable vest connected to an air supply unit.

The LibAirty Airway Clearance System is designed to promote breathing at different volumes, as the inflatable vest applies oscillating pressure on the chest and back, to augment peripheral and tracheal mucus movement towards the airway opening. The system's mode of operation is inspired by the principles of the Autogenic Drainage (AD) airway clearance technique, in which adjusting the depth and location of lung volumes during respiration generates shearing forces induced by airflow which loosen, mobilize, and move secretions (i.e., mucus) from the peripheral towards the central airways. Once the mucus reaches the larger airways, it can be expelled through coughing.

The LibAirty™ Airway Clearance System is a mobile, non-sterile, single patient use device, operated by mains power supply only.

The LibAirty™ Airway Clearance System consists of:

• . A control unit equipped with an air compressor that delivers air at regulated pressures to the vest and includes a display screen and operation buttons allowing the user to adjust therapy settings and manage device operation.
• . An inflatable vest (available in different sizes) that is fastened around the chest and consists of several air chambers.
• . A hose bundle that transfers the air from the control unit to the vest's chambers.
• . A Mobile Application (App) that is used to operate the system and provide instructions.

Synchronization Medical's LibAirty Airway Clearance System is an airway clearing device designed to promote bronchial drainage and aid in secretion clearance. The device consists of a vest with inflatable chambers, a control unit with an air compressor, and a mobile application. It operates by applying oscillating pressure to the chest and back, promoting movement of mucus from peripheral to central airways, where it can be expelled by coughing. The core principle of operation is based on Autogenic Drainage (AD) airway clearance technique.

The device was compared to the predicate device, The Vest Airway Clearance System, cleared under K142482.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list "acceptance criteria" in a quantitative manner for specific performance metrics from a clinical study for the purpose of regulatory clearance. Instead, it demonstrates substantial equivalence to a predicate device through a comparative clinical study. The primary effectiveness endpoint was the sputum weight expectorated. Non-clinical performance data included various verification and validation tests, but their specific acceptance criteria values (e.g., specific thresholds for pressure, noise, etc.) are not detailed in this summary.

Given the available information, the table below reflects the primary clinical performance finding and the general conclusion regarding acceptance:

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Respiratory Muscle Trainer is indicated for use as a Positive Expiratory Pressure (PEP) Device for improving the clearance of mucus secretions from the airways. Respiratory Muscle Trainer vibrates the airway walls to assist in loosening mucus and intermittently increases endobronchial pressure so that the airway patency can be maintained during exhalation, reducing the potential of mucus becoming trapped as it moves up the airways.

The device may also be useful in the removal of mucus from patients who have chronic bronchiectasis and in conjunction with a medical need for positive expiratory pressure (PEP) therapy.

Not Found

This document is a 510(k) clearance letter for a "Respiratory Muscle Trainer." It does not contain the information requested about acceptance criteria or a study proving device performance.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements and general controls. It also includes the "Indications for Use" for the device, but this is distinct from performance criteria and study results.

Therefore, I cannot provide the requested information based on the provided text.

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The Vest APX System is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, The Vest APX System is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for the purposes of collecting mucus for diagnostic evaluation.

The Vest APX System may be used for the pediatric population (6 months and older) to geriatric population.

The Vest APX System is a high-frequency chest wall oscillation device designed to be used in a wide variety of settings for enhancing the mobilization of bronchial secretions. The primary components of The Vest APX System consist of a control unit, hoses, and an inflatable garment. Oscillating positive pressure air pulses are applied to the garment by the control unit. The Blower provides the baseline pressure to the system. The user will input the different intensity from 1 -10 on the Graphical User Interface (GUI) and the blower will produce different static pressure based on speed. The air pulse generator (APG) provides the air pulsations (oscillations) based on the frequency input (ranging from 5 to 20 Hertz) provided by user via the GUI. The APG is driven by the Brushless Direct Current (BLDC) motor.

The resulting pressure pulses cause the garment to inflate and deflate against the chest of the patient, creating high-frequency chest wall oscillation and mobilization of bronchial secretions. This form of airway clearance therapy is referred to as high-frequency chest wall oscillation (HFCWO).

The provided text describes a 510(k) premarket notification for a medical device called "The Vest APX System." This document aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, "The Vest Airway Clearance Systems." The basis for this determination is a comparison of technological characteristics and performance data.

However, the document does not contain specific acceptance criteria, reported device performance metrics in a quantitative table format, details about a usability study beyond mentioning it, or information about sample size for test sets or training sets, ground truth establishment, or multi-reader multi-case studies as requested in the prompt. The "performance data" section only lists compliance with certain electromagnetic compatibility and safety standards, and biocompatibility.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, sample size for test sets or training sets, data provenance, number of experts, adjudication methods, details of MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The information primarily focuses on demonstrating substantial equivalence through similar intended use, indications for use, and technological characteristics, particularly through non-clinical testing.

Here's a summary of what is available regarding testing:

Nonclinical Tests Performed:

• Comparative pressure testing for the subject and predicate garments: This test would likely compare the pressure outputs or profiles generated by both the new device (The Vest APX System) and the predicate device (The Vest Airway Clearance Systems) when used with their respective garments. The goal would be to demonstrate similar functional performance in terms of pressure application for airway clearance.
• Usability testing per IEC 62366-1:2015 + A1:2020: This indicates that a usability study was conducted following international standards for medical device usability. The purpose is to evaluate if the device can be used safely and effectively by its intended users.
• Additional comparative pressure testing for the 16"-19" Child XS Garment with the subject and predicate devices: This specific comparative pressure test focuses on a particular garment size (Child XS) to ensure equivalent performance for this pediatric population.

Performance Data / Compliance:

The Vest APX System meets the following standards:

• IEC 60601-1-2 Edition 4.1 2020-09 (Electromagnetic Disturbances)
• ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (General requirements for basic safety and essential performance)
• IEC 60601-1-11 Edition 2.1 2020-07 (Requirements for medical electrical equipment in home healthcare environment)
• ISO 10993-1:2018 (Biological evaluation of medical devices - Biocompatibility)

What is NOT provided in the text:

• A specific table of acceptance criteria (e.g., minimum pressure output, maximum deviation, specific usability scores).
• Quantitative reported device performance to compare against acceptance criteria.
• Sample sizes for any of the tests (e.g., how many garments were tested for pressure, how many users in the usability study).
• Data provenance for any test data.
• Details on ground truth for any test (e.g., what was the "gold standard" for pressure measurements).
• Any information regarding experts involved in establishing ground truth or adjudication.
• Details about a multi-reader multi-case study (this device is a physical therapy device, not an AI diagnostic tool, so such a study would not be applicable).
• Standalone performance (again, not an AI diagnostic tool).
• Information on training sets, as this is not a machine learning or AI device.

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The SmartVest® Airway Clearance System, Model Clearway is designed to deliver high frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.

The modified Electromed SmartVest® Airway Clearance System, Model Clearway is an electrically powered percussor device designed to deliver high frequency chest wall oscillation (HFCWO) to aid in freeing mucus deposits in the lungs to improve bronchial drainage and airway clearance under the order of a physician's prescription. The primary components of both the proposed modified and predicate HFCWO Airway Clearance Systems consist of an Air Pulse Generator, an Inflatable Vest, and an Air Hose that connects the Generator to the Inflatable Vest. The Air Pulse Generator produces small volumes of pressurized air pulses that are rapidly delivered to the Inflatable Vest via the Air Hose at a selected oscillatory frequency between 5-20 times per minute (Hz). The Inflatable Vest imparts the oscillatory air pulses to the patient's external chest wall. These pressurized air pulses promote transient increases in airflow within the lungs that loosens mucus sufficiently to facilitate expulsion by the patient when normal respiratory function is not capable.

The provided text is a 510(k) summary for the Electromed SmartVest® Airway Clearance System, Model Clearway. It describes modifications made to a previously cleared device, focusing on changes to the Air Pulse Generator. The primary objective was to reduce size and weight, update the graphic user interface (GUI) to a touchscreen, and refine certain features. The document highlights the testing performed to demonstrate substantial equivalence to the predicate device.

Based on the provided text, the device is the Electromed SmartVest® Airway Clearance System, Model Clearway, which is intended to deliver high-frequency chest wall oscillation for airway clearance and bronchial drainage.

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

Key Takeaway from the Document:
This document is a Special 510(k) Summary, indicating that the manufacturer is demonstrating substantial equivalence of a modified device to a previously cleared predicate device, rather than bringing a completely novel device to market. As such, the performance data presented is primarily focused on demonstrating that the changes do not adversely affect safety or effectiveness, and that the modified device performs comparably to the predicate. This is not a clinical trial designed to establish standalone effectiveness against a control or to show human reader improvement with AI assistance.

Details Regarding Acceptance Criteria and Study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing, but it does not provide a specific table with numerical acceptance criteria and a direct comparison to reported device performance in a quantitative, side-by-side format. Instead, it states the type of testing and the statistical method used to demonstrate equivalence.

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

• Sample Size for Comparative Performance Testing: The text states, "Testing was conducted on both the predicate and proposed Generators using multiple Inflatable Vests that included the smallest and the largest sizes using the full range of Generator settings for pressure and frequency." A specific numerical sample size is not provided.
• Data Provenance: The document does not specify the country of origin of the data. Given it's a US FDA submission, it's highly implied the testing was conducted under US regulatory and quality system standards. The testing appears to be prospective as it's part of the design verification and validation for a modified product being submitted for clearance.

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

• This information is not applicable in the context of this 510(k) summary. The testing described is primarily engineering and performance verification of a medical device, not a diagnostic or AI-driven system requiring expert ground truth for interpretation (e.g., radiologists for medical images). The "ground truth" for the performance tests would be the measurement standards themselves (e.g., calibrated sensors for pressure, frequency, time).

4. Adjudication Method for the Test Set:

• Not applicable. This isn't a study involving human interpretation where adjudication is needed. (See point 3).

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 study was not done. This device is an airway clearance system, not an AI diagnostic tool. The "performance" described is the physical output of the device (air pulse pressure, frequency, time), not the diagnostic accuracy of an algorithm or its impact on human readers.

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

• Not Applicable. This is not an algorithm-only device. It is a physical medical device. The "performance" assessment is of the device's physical output and functional safety. The software component mentioned is for control of the device, not for diagnostic interpretation.

7. The Type of Ground Truth Used:

• For the comparative output performance testing: The ground truth is established by physical measurements against calibrated standards, with the predicate device's performance serving as the reference for equivalence.
• For electrical safety, EMC, and shipping testing: The ground truth is adherence to the specified international and industry standards (e.g., IEC 60601 series, ASTM D4169).

8. The Sample Size for the Training Set:

• Not applicable. This document describes the clearance of a physical medical device, not an AI model that requires a "training set" in the machine learning sense. The "design input requirements" mentioned in the context of software testing refer to functional specifications, not data for training an algorithm.

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

• Not applicable. (See point 8).

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The Electro Flo® 6 Airway Clearance System is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of 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 device is intended for home or institutional use by patients weighing at least 23 Kg.

The Electro Flo® 6 Airway Clearance System is a High Frequency Chest Wall Oscillation System (HFCWO), including all accessories and supplies.

Electro Flo® 6 Airway Clearance System comprises:

• An electrically powered Control Box with a power switch on the back and two knobs on the front: one knob provides five intensity settings, and the other provides six frequency settings,
• The Power Head, connected by a cable to the Control Box, ●
• The Carrying Case,
• The Information Manual, ●
• The Optional Self-Administrator® Strap that can hold the Electro Flo® 6 system Power Head and enable a patient to apply therapy to the back, unassisted.

The Electro Flo® 6 Airway Clearance System's operating mechanism is an electromechanical "hammer and anvil"; the hammer is the handheld body of the Power Head, and the anvil is the surface of the Power Head that is held in contact with the chest. Repeated electrical pulses from the Control Box separate the hammer and anvil. The Frequency knob of the Control Box controls the repetition rate, and the Power knob controls the pulse duration; there are 30 combinations.

When each electrical pulse ends, the force applied by the therapist's hand forces the hammer through the gap until it strikes the anvil and delivers a mechanical impulse to the chest. The resulting pressure wave radiates into the chest cavity to shake mucus loose. Because the energy transmitted to the chest vibrations is a multiple of the force applied by hand, the Electro Flo® 6 system acts as a "force multiplier" that provides the therapist with additional control.

The provided text is a 510(k) premarket notification for the Electro Flo® 6 Airway Clearance System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies or extensive standalone testing.

Therefore, many of the requested details, such as a table of acceptance criteria with reported performance, sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, and detailed standalone algorithm performance, are not applicable or not present in this type of FDA submission document.

Here's a breakdown based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not contain a table of specific performance acceptance criteria for clinical outcomes or diagnostic accuracy per se. Instead, it focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices in terms of indications for use, intended use, and technological characteristics.

The "performance data" section (Section XI) refers to bench testing to characterize mechanical performance and verify its nature as a high-frequency chest wall oscillator.

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

• Test Set Sample Size: Not applicable. The "test set" here refers to bench testing of the device itself, not a clinical patient cohort. The testing involved various settings (frequency, power, static loads) on a single physical device within a controlled laboratory setup.
• Data Provenance: The bench testing was conducted by Aeromethod Precision Engineering and Manufacturing, San Diego, CA, and analysis was performed by BioMedical Strategies, White River Junction, VT. This is laboratory-generated data, not from patient populations. It is inherently "prospective" in the sense of being planned testing, but not clinical.

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

Not applicable. For this type of mechanical device and 510(k) submission, "ground truth" is established through engineering and physics principles, and measured physical parameters, not expert human interpretation of complex data (like radiology images). The objective measurements from the bench test served as the data.

4. Adjudication Method for the Test Set:

Not applicable. There was no "adjudication" necessary as the test involved objective mechanical measurements.

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

Not applicable. This device is a therapeutic/clearance system, not a diagnostic AI tool, so a MRMC study is not relevant to its performance demonstration. The submission focuses on comparison to predicate mechanical devices.

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

• Yes, in the context of mechanical performance. The "bench data" section describes the standalone mechanical characterization of the device itself.
• The study demonstrated that the device, on its own when operated, functions as a high-frequency chest wall oscillator and its power output can be controlled.

7. Type of Ground Truth Used:

• Engineering/Physics Measurements: The ground truth for the bench testing was objective, quantitative measurements of mechanical output (vibration data, power spectra) collected from the device under controlled laboratory conditions, analyzed based on established engineering and physics principles.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set" of data in the computational sense. Its design and development would have involved engineering principles and iterative testing, but not "training data" in the AI context.

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

Not applicable, as there is no "training set" in the AI/ML sense for this device.

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AirPhysio is indicated for use as a Positive Expiratory Pressure (PEP) Device for improving the clearance of mucus secretions from the airways.

AirPhysio vibrates the airway walls to assist in loosening mucus and intermittently increases endobronchial pressure so that the airway patency can be maintained during exhalation, reducing the potential of mucus becoming trapped as it moves up the airways.

The device may also be useful in the removal of mucus from patients who have chronic bronchitis or bronchiectasis and in conjunction with a medical need for positive expiratory pressure (PEP) therapy.

AirPhysio is a small, handheld expiration resistance device, consisting of a hardened plastic mouthpiece at one end, a plastic cover with an opening at the other end, and a valve on the inside created by a high- density stainless-steel ball resting in a plastic conical cone. Exhalation through the device causes vibrations, assisting to loosen mucus from the airways. The resistance is increased by tilting the device.

The subject device is provided non-sterile for reprocessing in a home environment and has no accessories or configuration options.

The provided document is a 510(k) premarket notification for the AirPhysio Positive Expiratory Pressure (PEP) Device. It focuses on demonstrating substantial equivalence to a predicate device (Flutter D - Clement Clarke - K972859) rather than establishing novel acceptance criteria for a new type of device or conducting a performance study against a predefined clinical endpoint.

Therefore, the document does not contain the information required to populate all the sections of acceptance criteria and study details as requested. Specifically, it does not outline a clinical study with quantifiable acceptance criteria for a new device, a defined test set of patient data, expert ground truth establishment for medical images, MRMC studies, or standalone algorithm performance.

However, based on the information provided, here's what can be extracted and inferred regarding the "acceptance criteria" through the lens of substantial equivalence and the "study" conducted for AirPhysio:

Acceptance Criteria for Substantial Equivalence (Inferred from regulatory context)

For devices seeking 510(k) clearance, the "acceptance criteria" are typically demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing that it has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The performance tests conducted are to support this demonstration of similarity.

Table of Acceptance Criteria and Reported Device Performance (Inferred/Extracted from the document)

Study Details (as presented in the document):

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

   • Biocompatibility: 9 complete assemblies. Data provenance not explicitly stated, but implied to be laboratory testing for regulatory submission.
   • Reprocessing: Not specified, but involved independent laboratory tests.
   • Comparative Bench Testing: Not specified, but involved comparing "the AirPhysio device with the legally marketed predicate across different flow rates." This typically involves a range of controlled in-vitro conditions.
   • Usability Testing: Not specified for the number of participants, but it's human factors validation testing involving the "target user population." Data provenance not explicitly stated (e.g., country of origin), assumed to be for regulatory submission.
   • Note: This is not a clinical study on patient data but rather engineering and human factors testing on the device itself or typical users.

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

   • Not applicable. The ground truth here is the performance of the predicate device and established engineering/biocompatibility standards, not clinical labeling by expert readers of medical images.

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

   • Not applicable. This is not a study requiring reader adjudication of clinical data.

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 MRMC study was conducted. This device is a mechanical PEP device, not an AI-powered diagnostic or assistive tool.

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

   • Not applicable. This is a mechanical medical device, not an algorithm. Bench testing evaluates the "standalone" performance of the mechanical device.

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

   • For Biocompatibility: Established international standards (e.g., ISO 10993-1) and in-vitro testing results (cellular response, skin reactions).
   • For Reprocessing: Established hygiene and safety standards, verified by independent lab.
   • For Functional Performance: Performance characteristics (Mean PEP, Peak PEP, Amplitude PEP, Oscillation Frequency) of the predicate device served as the performance target/ground truth for comparison. Bench test measurements against engineering specifications.
   • For Usability: FDA human factors guidance and user interaction studies to ensure safe and effective operation based on predefined tasks and risk analysis.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device requiring a training set. The device is mechanical.

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

   • Not applicable.

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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 Model 1000 (hereinafter referred to as Monarch®) 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 an 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 torso 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 . This submission is specific to an expansion of the contraindication related to active implants. The device is identical to that cleared under K163378.

The provided text describes a 510(k) premarket notification for the Monarch Airway Clearance System Model 1000. This submission specifically addresses an expansion of the contraindication related to active implants, rather than an entirely new device or performance claim where a traditional acceptance criteria study would be performed. The device itself is stated to be identical to that cleared under K163378.

Therefore, the information presented focuses on demonstrating substantial equivalence to a predicate device, particularly regarding the magnetic interference for active implants, rather than proving the device meets new performance criteria.

Here's an analysis of the provided information, framed to address your questions as much as possible given the context:

1. Table of Acceptance Criteria and Reported Device Performance

Because this submission is an amendment to an existing clearance, focusing on a contraindication, the "acceptance criteria" here relate to demonstrating safety regarding magnetic interference with active implants. There aren't traditional performance metrics like sensitivity or specificity for a diagnostic device.

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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 Vest® Airway Clearance Systems is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice or treatment. Indications for this form of therapy are described by the American Association of Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy. According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Vest® Airway Clearance System is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for the purposes of collecting mucus for diagnostic evaluation.

The Vest® Airway Clearance System consists of an inflatable garment attached to an Air Pulse Generator that rapidly inflates and deflates the inflatable garment. This causes the chest wall to be gently compressed and released, which creates airflow within the lungs. This process moves the mucus toward the large airways where it can be cleared by coughing or suctioning. This type of Airway Clearance Therapy is referred to as High Frequency Chest Wall Oscillation (HFCWO).

The system consists of an Air Pulse Generator, connecting hose, and multiple styles and sizes of garments. The garments are single patient, multi-use.

The provided text is a 510(k) Summary for the Hill-Rom "The Vest® Airway Clearance Systems (Model 105)". This document states that the new device is substantially equivalent to a previously cleared predicate device (K024309) and therefore does not include a study demonstrating the new device meets specific acceptance criteria based on clinical outcomes or performance metrics like accuracy, sensitivity, or specificity. Instead, the focus is on comparative non-clinical bench testing to prove equivalence.

Therefore, much of the requested information, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets, is not applicable in the context of this 510(k) submission as it relies on substantial equivalence to a predicate device rather than novel performance demonstration.

However, I can extract the information provided regarding the testing performed to support substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim based on non-clinical testing rather than clinical performance metrics, the "acceptance criteria" here refer to the successful completion and comparison of non-clinical tests to demonstrate that modifications do not raise new safety or effectiveness concerns compared to the predicate device.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "comparative non-clinical bench testing." The tests performed are listed in the table above and in the "Non-clinical Testing Summary" section of the 510(k) summary (page 6 of the document). These tests were conducted to demonstrate that the updated device, with its minor modifications, performs equivalently to the predicate device and does not introduce new safety or effectiveness risks.

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 applicable to this 510(k) submission. The document describes non-clinical bench testing, which typically does not involve human sample sizes or data provenance in the same way clinical studies do. The testing involved comparing the proposed device components (Air Pulse Generator, connecting hose, garments) with the predicate device.

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 applicable. The ground truth for this type of non-clinical bench testing is based on engineering specifications and compliance with established standards, not expert clinical interpretation.

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

This information is not applicable as the testing is non-clinical bench testing against engineering 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

This information is not applicable. The device is an airway clearance system, not an AI-powered diagnostic device, and therefore MRMC studies are not relevant to its clearance.

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

This information is not applicable. The device is a physical medical device, not an algorithm, so standalone performance in this context is not relevant.

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

The "ground truth" for this submission are the established engineering specifications and international standards (e.g., IEC 60601-1, FCC Part 15B, etc.) that the device must meet, and the performance characteristics of the predicate device (K024309), which the new device aims to be substantially equivalent to.

8. The sample size for the training set

This information is not applicable. This is not an AI/machine learning device that requires a training set.

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

This information is not applicable as there is no training set for this type of device submission.

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