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The Propeller System includes the Propeller MDI Model 2 Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage.

The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the MDI sensor, and review symploms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician and healthcare providers.

The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their MDI and its use, to caplure other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and health care providers.

When used under the care of a physician with a prescribed MDI, the system can report on information caplured during the normal course of use, such as the lime between actualions that can be helpful in assessing MDI technique. When used under the care of a physician will a prescribed MDI, the system can be used to reduce the frequency of respiratory health symploms and exacerbations by increasing adherence to MDI medications through the use of feedback such as reminders and notifications, and self-management education.

The Propeller System is intended to be used in populations from Child (>2 years) to adult."

The Propeller system can be used both indoors and ouldoors; home, work and clinical settings, as well as on aircraft.

The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI medication(s) by a participant. The Propeller System is not inlended to diagnose or replace a diaonosis provided by a licensed physician. The Propeller System is not intended for use as an MDI dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI.

Electronic MDI Accessory

Here's an analysis of the Propeller System based on the provided 510(k) summary, structured to address your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the Propeller System (K140638) does not explicitly present a table of "acceptance criteria" with quantitative targets or thresholds for its performance. Instead, it focuses on demonstrating that the device functions as intended and is substantially equivalent to a predicate device (Asthmapolis, K121609) through various verification and validation tests. The reported device performance is largely described in terms of successful completion of these tests and compliance with relevant standards.

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

The summary does not specify a sample size for a "test set" or data provenance in the context of clinical performance data comparing human readers with and without the device, or studies involving a test set of patient data. The testing described is primarily non-clinical, focusing on device functionality, safety, and compliance with standards. It mentions "functional verification and device performance" and "performance testing of the MDI actuation sensor system to ensure data is logged accurately for MDI usage," but these are general descriptions of bench testing rather than studies involving patient data or a defined test set with associated sample size and provenance.

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

This information is not provided in the 510(k) summary. Given that the testing detailed is primarily non-clinical and focused on device functionality, there is no mention of "experts" establishing ground truth for a test set in a medical diagnostic or interpretive context.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. As there's no mention of a test set involving medical interpretations, there's no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human performance with and without AI (or device) assistance in the provided 510(k) summary. The device's purpose is to record and monitor MDI usage, provide feedback, and aid in adherence and self-management, not to assist human readers in interpreting medical images or data diagnostically.

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

The summary describes the core functionality of the device as standalone in its data collection and transmission aspects: "The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors..." and the "MDI actuation sensor system to ensure data is logged accurately for MDI usage." This implies that the sensor and associated software perform their function (recording actuations) without direct human intervention in the moment of data capture. However, the system's intended use is described as assisting physicians and patients, and empowering users to review and share information, implying a human-in-the-loop for interpretation and action based on the data. The testing primarily verifies the accuracy of this standalone data collection.

7. The Type of Ground Truth Used

For the functional verification of the MDI actuation sensor system, the ground truth would have been established through known, controlled MDI actuations performed during bench testing. For example, actuating an MDI a specific number of times and then verifying that the Propeller System accurately recorded that exact number. For compliance with standards (IEC, ISO, FCC), the "ground truth" is adherence to the technical specifications and requirements defined by those standards.

8. The Sample Size for the Training Set

The summary does not specify a sample size for a training set. The Propeller System is primarily a data capture and feedback system, not a device that relies on complex machine learning models trained on large datasets in the way an AI diagnostic tool would. Its functionality is based on sensors and software logic.

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

Since there is no mention of a training set for a machine learning model, the concept of establishing ground truth for a training set is not applicable in the context of the information provided for this device. The "training" for such a system would involve software development and engineering processes, with verification against design specifications and functional requirements.

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