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Vortex is indicated for use as a spacer/valved holding chamber for use in delivery of aerosol medication with metered dose inhalers.

Vortex is a new spacer/holding chamber designed to assist patients using metered dose inhalers (MDI) for aerosolized drug delivery. Vortex may provide enhanced drug delivery, ease of use and ability to clean/disinfect the device.

Vortex is a reusable device consisting of an aluminum cylinder with an elastomeric fitting on one end to accept metered dose inhalers and a valved mouthpiece on the other end to interface with the patient. The elastomeric fitting may be removed for cleaning and/or replacement.

Vortex will be available as a stand-alone item and will also be available packaged with a mask.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for the "test set" (i.e., the number of devices or experimental replicates used in the non-clinical testing). It only states that "Testing to compare Vortex to Aerochamber was conducted."

The data provenance is retrospective, as the testing was conducted for the purpose of a 510(k) submission to demonstrate substantial equivalence to an already legally marketed device. The country of origin of the data is not explicitly stated.

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

This information is not applicable as the provided document describes non-clinical performance testing of a medical device (a valved holding chamber/spacer), not a diagnostic or AI-driven system that requires expert-established ground truth. The "ground truth" here is objective physical measurements (e.g., drug delivery, resistance).

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Adjudication methods are typically relevant for subjective assessments or when multiple experts review the same data, which is not the case for this non-clinical performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not completed/is not required to show substantial equivalence." MRMC studies typically involve human readers and clinical outcomes.

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

This question is not applicable as the device (Vortex valved holding chamber) is a physical medical device, not an algorithm or AI system. Its performance is measured directly, not through an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this device's performance assessment was based on objective physical measurements and established testing methodologies. For example:

• Drug delivery: Measured quantitatively according to FDA guidance.
• Fit with MDI elbows: An objective assessment of physical compatibility.
• Inhalation and exhalation resistance: Measured quantitatively using instruments (e.g., in pascal at a specific flow rate).

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set. The performance testing was conducted on the physical device itself.

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

This information is not applicable for the same reason as point 8.

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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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