(142 days)
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.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Performance | Complies with predetermined specifications for recording and monitoring SMI actuations. | Complies with predetermined specifications. |
| Electromagnetic Compatibility (EMC) | Meets relevant EMC standards. | EMC testing completed and confirmed compliance. |
| Electrical Safety | Meets relevant electrical safety standards. | Electrical testing completed and confirmed compliance. |
| Mechanical Durability | Meets predetermined mechanical durability requirements. | Mechanical durability testing completed and confirmed compliance. |
| Software Verification and Validation | Software functions as intended, is reliable, and meets specifications. | Software verification and validation testing completed and confirmed compliance. |
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.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).