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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 Vibralung Acoustical Percussor is indicated as an airway secretion clearance device that creates vibrations in the airways and as a lung expansion device that applies Positive Expiratory Pressure (PEP) as a patient breathes through the device. It may be used to promote bronchial drainage, airway clearance and expectoration. The Vibralung may be used simultaneously with aerosol drug delivery.

The proposed Vibralung Acoustical Percussor provides airway clearance therapy (ACT) and promotes mucokinesis by inducing vibration in airways by vibrating the column of gas in the airways at a variety of different frequencies. It is an acoustic device that induces oscillatory sound waves by means of an electro-acoustical transducer (audio speaker), referred to as the "Hand-held Transducer" or HHT, which is interfaced to the patient's airway through a mouthpiece. The transducer unit is connected to a frequency generator, referred to as the "Treatment Control Unit" or TCU, which is set to produce frequencies between 5 and 1,200 Hz in different ranges that are user-selectable.

The HHT directs sound waves into the patient's airways through a waveguide and a mouthpiece.

In addition, the Vibralung can provide Positive Expiratory Pressure (PEP) and may simultaneously provide nebulized aerosol drug delivery.

There are two different Y-adapters available that act as "waveguides" to direct sound waves from the audio speaker in the HHT to the mouthpiece that is held in the patient's mouth in the same manner as with other breathing treatment mouthpieces.

The purpose of the Y-adapters is two-fold:

• · To direct the sound waves into the airway opening, and
• · To provide separate pathways for inhalation and exhalation gas flow with minimal mixing and rebreathing of exhaled gas.

Here's a breakdown of the acceptance criteria and study information for the Vibralung Acoustical Percussor, based on the provided document:

Acceptance Criteria and Device Performance

The document describes a substantial equivalence comparison rather than explicitly stating numerical acceptance criteria for device performance against predefined thresholds. Instead, the device's performance is deemed "substantially equivalent" to predicate devices, implying that its performance is comparable and acceptable. The core "performance" criteria are based on its ability to generate acoustic frequencies and provide Positive Expiratory Pressure (PEP) within ranges consistent with the physiological effects of the predicate devices.

Table of Acceptance Criteria (Implied by Substantial Equivalence) and Reported Device Performance:

Study Information

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

• Study 1: 10 subjects (mild to moderate Cystic Fibrosis). Retrospective/Prospective information is not explicitly stated, but the description "were subjected to two treatments... on two different days" suggests a prospective, interventional design. The country of origin is not specified.
• Study 2: 11 subjects. Retrospective/Prospective information is not explicitly stated, but the description "designed to assess the effects... for five days" suggests a prospective, interventional design. The country of origin is not specified.
• Non-clinical Testing: Details on sample size for components/materials are not provided, only the types of tests performed.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the sense of independent review or adjudication of study outcomes. The studies focused on objective physiological measurements (LCI, sputum production, pulmonary function) and safety assessments.

4. Adjudication Method for the Test Set:

Not applicable. The studies did not involve subjective assessments requiring adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:

Not applicable. This device is not an AI-powered diagnostic or interpretive tool that would involve human readers or MRMC studies.

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

Not applicable. This is a medical device for airway clearance, not an algorithm. The "standalone" performance would be its inherent physical and physiological effects, which are what the non-clinical and clinical studies assess.

7. The Type of Ground Truth Used:

• Clinical Studies (Study 1 & 2): Physiological measurements and clinical outcomes, such as:
  • Lung Clearance Index (LCI)
  • Pulmonary function (FVC, FEV1)
  • Peripheral oxygen saturation (SaO2)
  • Total sputum production (wet weight, pellet weight, dry weight)
  • Patient symptoms and safety assessments.
• Non-Clinical Testing: Engineering and performance specifications, such as inspiratory resistance, airway pressure, sound pressure level, mechanical dead space, particle characterization (for aerosol performance), acoustical testing (frequency ranges), electrical safety (IEC standards), accelerated aging, and cleaning validation.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI or machine learning system that requires a "training set."

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

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

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The Philips Respironics SimplyClear device promotes airway clearance by gradually applying air pulse generated high frequency oscillatory vibrations on the positive and negative pressures applied to the chest wall via the airways. The high frequency oscillatory vibrations release mucus from the bronchial walls, increasing mobilization. The shift in pressure produces a high expiratory flow from the lungs, promoting the clearance of the mobilized secretions via coughing.

The Philips Respironics SimplyClear device may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. It is for use on adult or pediatric patients having difficulty with secretion clearance and/or inability to cough.

The SimplyClear device is for use in a hospital, institutional environment or in the home.

The Philips Respironics SimplyClear device promotes airway clearance by loosening, mobilizing and clearing secretions. The loosening and mobilization occurs by gradually applying air pulse generated high frequency oscillatory vibrations on the positive and negative pressures applied to the chest wall via the airways. The high frequency oscillatory vibrations release mucus from the bronchial walls, increasing mobilization. The positive to negative shift in pressure produces a high expiratory flow from the lungs, promoting the clearance of the mobilized secretions via coughing.

The SimplyClear device combines the loosening and mobilization functionality of the Vest Airway Clearance System (K024309) with the secretion clearance functionality of the CoughAssist device (K002598), Dima Italia Negavent DA-3 Plus Pegaso (K072292) and the CoughAssist T70 device (K121955).

Here's a breakdown of the acceptance criteria and the study information for the Philips Respironics SimplyClear device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results in the format requested. Instead, it describes various "performance testing" and "verification activities" against "design input specifications" and "product requirements." The acceptance criteria are broadly implied by the successful completion of these tests.

However, based on the Testing Summary table and the Performance Data section, we can infer the tested features and their successful verification:

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

• Sample Size: Not explicitly stated as a number of devices or patient cases. The testing involved "defined patient test cases" but the quantity isn't specified.
• Data Provenance: The study was a non-clinical bench testing study. It used simulated patient test cases and "worst-case scenario inputs" rather than actual patient data. Therefore, there's no country of origin for patient data (as none was used) and it is not retrospective or prospective in the human-subjects sense.

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 study where "ground truth" was established by the device's design input specifications and expected performance, rather than expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. As a non-clinical bench testing study, there was no need for adjudication by experts to establish a ground truth. Performance was assessed against predefined engineering specifications.

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

Not applicable. This device is a powered percussor for airway clearance, not an AI-assisted diagnostic or interpretation tool that would involve human readers.

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

Yes, in a way. The "performance data" describes standalone validation of the device's algorithms and hardware performance against specifications using "black-box" and "white-box" bench testing. This confirms the algorithm and system's functional integrity independent of a human operator's assessment of patient outcomes during therapy, although a human is operating the device.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical testing was based on the device's design input specifications and product requirements. This would include engineering specifications for pressure, flow, timing, oscillation parameters, user interface functionality, data integrity, and power management.

8. The Sample Size for the Training Set

Not applicable. This document describes a traditional medical device (hardware and embedded software) verification and validation process, not a machine learning or artificial intelligence (AI) device that would involve a "training set" for an algorithm. The software algorithms were designed and tested, not "trained" on data.

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

Not applicable, as no training set was used.

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