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The Propeller System includes the Propeller Sensor Model 2017-B. The sensor is an accessory device intended for singlepatient use to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage for the Neohaler and Breezhaler devices.

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 DPI sensor, 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 DPI 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 DPI, 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 DPI 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 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 DPI medication(s) by a participant.

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

Dry Powder Inhaler (DPI) / Neohaler Accessory that monitors inhaler usage. The portable sensor mounts on top of a DPI and records inhalation events when the inhaler is used.

The provided text describes the Propeller Sensor Model 2017-B, an accessory device for Dry Powder Inhalers (DPIs), and its substantial equivalence to a predicate device (Propeller Sensor Model 2015-E). However, the document does NOT contain information regarding acceptance criteria and a study that proves the device meets those criteria in the context of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the document focuses on:

• Regulatory clearance (510(k) summary): Demonstrating "substantial equivalence" to a previously cleared device.
• Technological comparison: Highlighting the similarities between the new device and the predicate.
• Bench testing: Confirming compliance with various standards and specifications (e.g., electrical safety, biocompatibility, battery performance).

Therefore, I cannot provide the requested information about acceptance criteria and performance metrics for diagnostic purposes. The device described here is a sensor for monitoring inhaler usage, not a diagnostic tool requiring such performance studies.

Here's what can be extracted from the document regarding the type of testing and its conclusion:

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

Since the device is an accessory for monitoring inhaler usage and not a diagnostic device, the acceptance criteria are not in terms of diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they relate to compliance with regulatory standards and functional specifications.

2. Sample size used for the test set and the data provenance:
Not applicable as no diagnostic performance study involving test sets from patients was conducted. The testing focused on engineering, software verification, and biocompatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment by experts for diagnostic performance was required as it's not a diagnostic device.

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. This device is a sensor for inhaler usage, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. While the device does have an "algorithm" to detect inhaler actuations, the document does not describe it in terms of standalone "performance" in the way a diagnostic algorithm would be evaluated (e.g., sensitivity/specificity for a disease). The testing confirms its functional operation (e.g., compliance with specifications) rather than diagnostic accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the context of diagnostic performance. The "ground truth" for the device's functionality would likely be physical measurements and observations during bench testing to confirm accurate detection of inhaler actuations.

8. The sample size for the training set:
Not applicable. As a non-AI diagnostic device, there is no mention of a "training set" in the context of machine learning. The device's operation is based on physical principles (sensors detecting actuation) rather than learned patterns from a training dataset.

9. How the ground truth for the training set was established:
Not applicable.

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