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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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