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The Propeller System includes the Propeller Sensor Model 2014-R. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed SMI 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 SMI sensor, and report and review symptoms 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 SMI and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians, and health care providers.

When used with a prescribed SMI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing SMI technique.

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 outdoors; 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 SMI medication(s) by a participant.

The output of the Propeller System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Propeller System is not intended for use as an SMI dose counter, nor is it intended to indicate the quantity of medication remaining in an SMI.

Electronic Soft-Mist Inhaler (SMI) Accessory. The Propeller Sensor Model 2014-R keeps track of medication use, with a record when a soft mist inhaler is used. The sensor is a small device that attaches to the top an existing inhaler. Both the subject device and the predicate device use technology that includes bluetooth wireless connectivity which connects to the same previously cleared Propeller Health software system together with a mobile phone or wireless gateway.

The provided document is a 510(k) summary for the Propeller Sensor Model 2014-R, focusing on its reclassification for Over-The-Counter (OTC) use. It does not describe an AI/ML-based medical device. Therefore, the questions related to AI/ML model performance, such as acceptance criteria based on AI metrics, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, or MRMC studies, are not applicable.

The document primarily addresses the substantial equivalence of the Propeller Sensor Model 2014-R for OTC use to its previously cleared prescription-use version (K142960) and another OTC predicate (K142516).

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on compliance with established medical device standards and the device's functional equivalence to its predicate. There isn't a table presenting specific acceptance criteria and reported device performance in the context of an AI/ML device (e.g., sensitivity, specificity, or AUC). Instead, the "performance" is demonstrated by adherence to safety and functional standards.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. The testing described is primarily focused on engineering validation, safety, and functional equivalence, not on a data-driven performance evaluation with a "test set" in the context of AI/ML.
• Data Provenance: Not applicable for AI/ML. The device's functionality involves recording SMI usage events, but the testing described is not based on patient data in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth concept for an AI/ML test set is not relevant here as this is not an AI/ML device.

4. Adjudication method for the test set:

Not applicable. There is no mention of an adjudication method, as it doesn't apply to the type of testing described (engineering, safety, functional equivalence).

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:

No, an MRMC study was not done. This is not an AI/ML device, and its purpose is not to assist human readers in interpretation.

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

No, a standalone algorithm performance study was not done. This is not an AI/ML device. The device itself is a physical sensor and associated software for tracking inhaler use.

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

Not applicable. Ground truth for AI/ML models is not relevant here. The "ground truth" for the device's function is simply the actual actuation of the SMI, which the sensor is designed to detect and record. The testing confirmed the sensor's ability to accurately record these events and its compliance with safety and electrical standards.

8. The sample size for the training set:

Not applicable. There is no AI/ML model described that would require a training set.

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

Not applicable. There is no AI/ML model described that would require a ground truth for a training set.

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