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The Aradigm Corporation SmartMist™ Asthma Management System is intended for use by asthma patients who self medicate with metered dose inhalers (MDI) and who measure peak expiratory flow rate (PEFR) as part of their asthma management programs.

The Aradigm Corporation SmartMist™ Asthma Management System is a single patient use prescribed metered dose inhaler (MDI) accessory and peak flow meter. The SmartMist™ is composed of the non-disposable, battery powered, portable SmartMist™ Controller and the SmartMist™ Spirometry Airway. In addition to it; primary purpose of assisting with drug delivery and its secondary purpose of monitoring lung function of patient compliance monitoring is available.

The SmartMist™ Asthma Management System is designed to work with a particular style of MDI, without modification. The entire MDI-canister and plastic actuator-is inserted into the SmartMist™ without the introduction of any flaps or valves. The MDI is easily removed for cleaning or for manual dosing should the SmartMist™ become inoperable.

As the patient inhales through their prescribed MDI that they have inserted into the SmartMist™, the device's microprocessor monitors the inhalation flow rate and volume detected by the system's pressure transducer. If the inhalation flow rate and volume fall within the factory programmed parameters, the microprocessor triggers its mechanism to actuate the MDI canister; aerosol medication is delivered to the patient.

Feedback regarding the inhalation flow rate is provided to the patient in the form of red and green LEDs. When the green LED is illuminated, the patient is breathing at the recommended inhalation rate for aerosol drug delivery.

The SmartMist™ Asthma Management System also functions as an electronic peak flow meter. When the user exhales through the Spirometry Airway, the device's microprocessor determines the peak expiratory flow rate (PEFR) and forced expiratory volume in one second (FEV). The peak flow rate is displayed to the patient in the liquid crystal display window.

A record of PEFR, FEV , and dosing (inhalation) events is stored in the SmartMist™ memory for later retrieval, if desired, by a trained medical practitioner. Therefore, the SmartMist™ also provides patient compliance monitoring at the option of the practitioner.

Use of MDI medications with the SmartMist™ provides to the patient continual inhalation technique training. Since the SmartMist™ will not deliver the medication unless the patient's inhalation is at the proper flow rate, the patient eceives technique feedback each time the SmartMist™ is used for delivery of medication. Red and green indicators provide easily understood flow rate feedback to the patient.

This document appears to be a 510(k) summary for the Aradigm SmartMist™ Asthma Management System, not a study report per se. Therefore, it primarily describes the device and its intended use, and generally states that testing was performed and met standards, rather than providing detailed results of a specific clinical trial with acceptance criteria for device performance.

Based on the information provided, here's an attempt to answer your questions to the best of what's available in the text:

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

The document does not provide a table with specific quantitative acceptance criteria or detailed reported device performance in the way a clinical study report would. It states that:

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

This information is not provided in the document. The text refers to "testing" performed but does not specify the sample size of participants or devices, nor whether the data was retrospective or prospective, or its origin.

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 in the document. The context of this device (medical device for patient use, not an AI diagnostic tool) does not typically involve expert consensus for ground truth in the same way an image analysis algorithm might. Ground truth for spirometry and spray delivery would typically be established by calibrated reference equipment, not expert opinion.

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

This information is not provided and is not applicable in the context of this device's testing described. Adjudication methods like 2+1 or 3+1 are typically used in studies where human experts are making subjective assessments that need to be reconciled (e.g., in reading medical images). The testing described for the SmartMist™ appears to involve objective measurements against established technical standards (ATS recommendations, accepted spray delivery 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

An MRMC comparative effectiveness study was not conducted or reported. This type of study is relevant for AI diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The SmartMist™ is an assistive device for drug delivery and monitoring, not an AI diagnostic tool that human "readers" would use to make interpretations.

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

The document describes testing of the device itself (SmartMist™), which inherently includes its internal algorithms for monitoring and actuating based on patient inhalation. Therefore, the "testing" mentioned for spirometry and spray delivery accuracy would reflect standalone performance of the device's functions. The entire device, including its algorithms, was tested against ATS recommendations and accepted spray delivery standards.

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

The ground truth for the testing appears to be based on:

• ATS (American Thoracic Society) recommended standards for spirometry monitoring. These are established physiologic and technical standards.
• Accepted standards for the average weight of a metered spray from an MDI. These are likely regulatory or industry-accepted physical measurement standards.

8. The sample size for the training set

This information is not provided and is not applicable in the context of this device. The SmartMist™ is not an AI/ML algorithm that undergoes "training" in the data science sense. Its "factory programmed parameters" for inhalation flow rate are pre-set based on medical and engineering principles, not learned from a dataset.

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

Not applicable as there is no "training set" for this device in the machine learning sense. The device's operational parameters (e.g., "factory programmed parameters" for inhalation flow rate and volume) would be established through engineering design, clinical understanding of optimal inhalation techniques, and potentially in-vitro testing, rather than a data-driven training process with established ground truth.

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