Search Results

The Propeller System includes the Propeller 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 Diskus 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) / Diskus Accessory that monitors inhaler usage. The portable sensor mounts on top of a DPI and records inhalation events when the medication is used.

This document (K152882) describes the 510(k) premarket notification for the Propeller Sensor Model 2014-D. It explicitly states that no new testing was performed for the OTC indication, and no clinical testing was required. The device's substantial equivalence is based on its identity to a previously cleared predicate device (K143671) and another (K142516) with only a change from MDI to DPI.

Therefore, the detailed information requested regarding acceptance criteria, study sample sizes, ground truth establishment, expert involvement, and MRMC studies are not available in this specific regulatory submission as no new performance studies were conducted for this 510(k) clearance.

However, based solely on the provided document, here's what can be inferred and what remains unknown regarding device performance validation:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no new performance testing was conducted, there are no specific numeric acceptance criteria or reported device performance metrics presented in this document for the Propeller Sensor Model 2014-D in its OTC indication. The primary "performance" assessed was functional equivalence to the predicate.

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

• Sample Size: Not applicable/not provided for new performance testing, as none was conducted specific to this 510(k). The functional testing performed was "bench testing."
• Data Provenance: Not applicable/not provided for new performance testing. The document refers to prior testing for predicate devices.

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

• Not applicable, as no new performance studies with ground truth establishment were conducted for this 510(k). Hazard analysis involved review by (unspecified) experts during the predicate device clearance process.

4. Adjudication Method for the Test Set:

• Not applicable, as no new performance studies were conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No, an MRMC study was not done. The device does not involve human interpretation of medical images or data that would necessitate such a study. It is an accessory to monitor inhaler usage.

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

• The "functional testing" performed would be considered analogous to standalone performance, as it tests the device's ability to record actuations independently. However, no specific metrics like accuracy, sensitivity, or specificity are provided for this functional test for the current submission, as it relied on the established performance of the predicate. The device's primary function is data acquisition and transmission, not algorithmic interpretation requiring performance metrics typical of AI/ML devices.

7. The Type of Ground Truth Used:

• For the predicate device's original clearance, functional ground truth would have been established by comparing the device's recorded actuations against directly observed or mechanically triggered actuations of the DPI/MDI. This document relies on the ground truth established for the predicate device.

8. The Sample Size for the Training Set:

• Not applicable. This device is not described as utilizing a machine learning algorithm that requires a training set in the context of this 510(k). Its function is based on sensor detection, not pattern recognition learned from data.

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

• Not applicable, as there is no mention of a training set for a machine learning algorithm in this submission.

In summary, this 510(k) clearance (K152882) for the Propeller Sensor Model 2014-D focused on demonstrating substantial equivalence to previously cleared predicate devices (K143671 and K142516) and a change in indication (Prescription Use to OTC). It explicitly states that no new clinical or performance testing was required or performed for this specific submission. The acceptance criteria were implicitly met by demonstrating that the device is identical in technology and functionality to the predicate and that the change to OTC status did not introduce new safety concerns based on hazard analysis and bench testing.

Ask a specific question about this device

The Propeller System includes the Propeller MDI Model 2 OTC 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 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 respiratory medication(s) and its use, to capture other patientreported information and outcomes, and to allow that information to be shared with their caregivers, physicians and health care providers.

When used with a prescribed MDI, 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 MDI technique.

When used under the care of a physician with a prescribed MDI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to MDI or other inhaled 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 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 aircraff.

The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI or other inhaled medication(s) by a participant.

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

The Propeller System includes the Propeller MDI Model 2 OTC 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 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 respiratory medication(s) and its use, to capture other patientreported information and outcomes, and to allow that information to be shared with their caregivers, physicians and health care providers.

This document is a 510(k) premarket notification for the Propeller System Model 2 OTC. It is primarily focused on seeking approval for over-the-counter (OTC) use of a device previously approved for prescription use. As such, the information provided relates more to the comparison with a predicate device and the validation for the change in use status, rather than a detailed study proving performance against new, specific acceptance criteria for a novel device.

Given the information provided, it states: "No clinical testing was required" and "The device is identical to the predicate device." Therefore, a traditional study proving the device meets acceptance criteria as would be for a de novo or novel device is not present here. The focus is on demonstrating that the previously established performance and safety remain valid for OTC use.

However, I can extract information related to the validation testing for OTC and the conclusion regarding safety, which can be interpreted as fulfilling new "acceptance criteria" for the change in intended use.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria

The provided document describes a 510(k) premarket notification for the Propeller System Model 2 OTC, which is a re-marketing of a previously approved prescription-use device (Propeller System Model 2) for over-the-counter (OTC) use. The primary goal of this submission is to demonstrate that the device continues to meet specified requirements for the change in status from "Prescription Use" to "OTC". Therefore, the "acceptance criteria" and "study" are framed around this change in intended use, rather than a de novo evaluation of the device's fundamental performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "No clinical testing was required". This indicates that the validation for OTC use did not involve a study with human subjects or a test set in the traditional sense of a clinical trial. The testing performed was likely bench testing, software validation, and a hazard analysis related to the change in labeling and intended use. Therefore, a "sample size for the test set" is not applicable in the context of clinical performance data, and "data provenance" (country of origin, retrospective/prospective) is not relevant to this type of regulatory submission.

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

Not applicable. As no clinical testing was required and the device is stated to be identical to its predicate, there was no "test set" requiring expert ground truth establishment in a clinical performance study. The "ground truth" here is the established safety and performance of the predicate device and the assessment that these characteristics are maintained for OTC use.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as no clinical test set requiring adjudication was performed.

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. The Propeller System is an electronic MDI accessory for recording and monitoring inhaler actuations, not an AI-powered diagnostic imaging tool. Therefore, an MRMC study and effects on "human readers" are not relevant to this device.

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

The device itself (the Propeller MDI Model 2 OTC Sensor) operates in a standalone manner to record actuations. The accompanying mobile and web applications also process and display data. The document confirms that "Completed EMC, electrical, safety, mechanical durability, software verification and validation testing confirms this result." This implies that the device's core functions (including its algorithms for detecting actuations) were validated. However, the document does not provide details on the performance metrics of these algorithms (e.g., accuracy of actuation detection) as this was likely established and accepted with the predicate device. The focus here is on the transition to OTC.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For the validation of the device itself (as opposed to its OTC reclassification), the ground truth for actuation detection would typically be established against physical measurements or manual observations of MDI actuations. However, this information pertains to the predicate device's initial approval and is not detailed in this 510(k) submission which focuses on the OTC change. For the OTC reclassification, the "ground truth" was essentially the confirmed safety and effectiveness of the identical predicate device and the absence of new hazards identified through the hazard analysis for OTC.

8. The Sample Size for the Training Set

Not applicable. This device is an electronic MDI accessory, not an AI/machine learning model that typically requires a training set of data. Its function is based on sensor data interpretation, not predictive modeling from a large dataset.

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

Not applicable, as there is no "training set" in the context of this device's function as described.

Ask a specific question about this device

The Propeller System includes the Propeller SMI Model 2014-R 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 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 under the care of a physician 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; 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 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 provided text is a 510(k) Premarket Notification for the Propeller System Model 2014-R, which is an accessory device intended to assist physicians and patients in recording and monitoring the actuations of prescribed Soft-Mist Inhaler (SMI) usage. The document focuses on establishing substantial equivalence to a legally marketed predicate device (Propeller System K140638) rather than presenting a detailed study proving the device meets specific acceptance criteria related to its direct performance as a diagnostic or therapeutic tool.

Therefore, much of the requested information, particularly regarding diagnostic performance metrics, expert adjudication, ground truth establishment for a test set, and multi-reader multi-case studies, is not applicable or cannot be extracted from this type of regulatory submission. The device is primarily a data collection and transmission accessory.

However, based on the Test Summary provided, some information can be inferred or directly stated regarding the device's functional performance and safety.

Here's the breakdown of what can be extracted:

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

The document states: "Test results indicate that the Propeller Sensor Model 2014-R and its predicate Propeller System Model 2 complies with predetermined specifications. Completed EMC, electrical, safety, mechanical durability, software verification and validation testing confirms this result."

While specific numerical acceptance criteria and reported performance values are not provided in this summary, the statement implies that the device met all established specifications within these categories.

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

The document does not specify the sample size (e.g., number of devices tested, number of actuations recorded) for the various tests mentioned (EMC, electrical, safety, mechanical durability, software V&V). It also does not mention the data provenance in terms of country of origin or whether the tests were retrospective or prospective, as these are typically part of a detailed test report not included in this summary.

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

This information is not applicable and not provided. The device (Propeller Sensor Model 2014-R) is not a diagnostic device that requires expert-established ground truth for its core function of recording SMI actuations. The "ground truth" for its performance would likely be a known physical actuation or a simulated event, verified by test equipment or direct observation, not expert clinical consensus.

4. Adjudication method for the test set

This information is not applicable and not provided for the same reasons as #3.

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 such study was mentioned or required. The device is an accessory to an SMI, primarily for data collection and monitoring, not for AI-assisted human reading of medical images or diagnostic tests. The document explicitly states: "No clinical testing was required."

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

The device itself is a sensor that records physical events (SMI actuations). Its "standalone performance" would be its accuracy in detecting and transmitting these events. The software verification and validation testing would cover the algorithm's performance within the system, but the document does not detail specific metrics like recall, precision, or F1-score for this function as it's not a diagnostic algorithm.

7. The type of ground truth used

For the functional aspects (e.g., detecting an actuation), the ground truth would likely be a direct physical actuation of the SMI, verified by mechanical means or direct observation during testing. For electrical, EMC, and safety, the ground truth would be established by reference to relevant industry standards and objective measurements. The document does not specify this in detail.

8. The sample size for the training set

This is not applicable and not provided. The device is a hardware sensor with associated software for data collection. It does not appear to involve machine learning models that require a "training set" in the traditional sense for diagnostic prediction. Its software performs data capture, storage, and transmission, which are typically validated through testing against requirements, not trained on extensive datasets.

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

Not applicable, as there is no mention of a training set for a machine learning model.

Ask a specific question about this device

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.

Ask a specific question about this device