(178 days)
The Propeller System includes the Propeller Model 2014-D 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 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 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 under the care of a physician 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.
When used under the care of a physician with a prescribed DPI, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to DPI 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; 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 diagnose or replace a 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
The subject device uses technology similar to the predicate device including Bluetooth wireless connectivity which connects to the same previously cleared Propeller Health software system together with a mobile phone or wireless gateway. The Sensor Model 2014-D is different from the Sensor Model 2 in that it contains enclosure size differences required to install on the DPI inhaler and electronic sensors to detect Propeller Sensor 2014-D use rather than a button which was used in the predicate device.
The provided text describes the Propeller Sensor Model 2014-D, an accessory device for Dry Powder Inhalers (DPIs), and its comparison to a predicate device. However, the document does not contain specific acceptance criteria values or a detailed study explicitly proving the device meets these criteria in the format requested.
The text generally states that "Test results indicate that the Propeller Sensor Model 2014-D and its predicate Propeller System Model 2 complies with predetermined specifications. Software verification and validation testing confirms this result." and "the subject device meets the predetermined performance specifications as was the case with the predicate device." without providing the actual specifications or the detailed results of the tests in a quantitative manner.
Therefore, I cannot populate the table and answer all questions directly from the provided input. I will extract what information is present and indicate where the information is missing.
Here's the breakdown based on the provided document:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Specific Values/Metrics) | Reported Device Performance (Specific Values/Metrics) |
|---|---|
| Not explicitly stated with specific values in the document. The document generally refers to "predetermined specifications." | Not explicitly stated with specific values in the document. The document generally states compliance with "predetermined specifications" and that the device "meets the performance specification." |
| Insertion and removal force | Device meets the performance specification for insertion and removal force and does not damage the Diskus device or label. |
| Air-flow | Bench testing included air-flow. (No specific performance data given) |
| PSD Safety Assessment using Electrostatic Measurements and analysis of Electric Fields from the sensor on the Diskus medication | Bench testing performed. (No specific performance data given) |
| In-home wireless compatibility | Co-existence testing to confirm in-home wireless compatibility. (No specific performance or results given) |
| Biocompatibility (primary skin irritation, dermal sensitization, ISO Agarose Overlay, ISO Guinea Pig Maximization Sensitization, ISO MEM Elution, ISO Intracutaneous Irritation, ISO MEM Elutiion Post-Cleaning) | Compliance confirmed. (No specific results or acceptance criteria values given) |
| Compliance to IEC 60601-1, IEC60601-2, IEC60601-6, IEC60601-11, ISO 10993 | Compliance confirmed. (No specific results or acceptance criteria values given) |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: The testing appears to be bench testing and software verification/validation conducted by the manufacturer, Reciprocal Labs Corporation, as part of their 510(k) submission. No specific country of origin for test data or whether it was retrospective/prospective is mentioned, but it generally refers to pre-market testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The document outlines bench testing, software testing, and compliance with standards, but does not refer to expert-established ground truth in the context of diagnostic accuracy for this type of device. The ground truth for actuation detection would likely be based on physical detection during bench tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. This type of adjudication is typically used in clinical studies for diagnostic devices, which was stated as "No clinical testing was required" for this device.
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. The device is a sensor system for recording DPI actuations and providing user information/feedback, not an AI-assisted diagnostic tool for human readers. "No clinical testing was required."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The listed tests (bench testing, software verification/validation, compliance to standards) would evaluate the device's performance independently of human interaction in the loop, beyond basic usability. The device's primary function (recording actuations) is automated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the core function of detecting DPI actuations, the ground truth would have been established through controlled physical actuations on the bench, likely using mechanical or human operation with direct observation or other validated measurement methods (e.g., measuring force, movement, etc.). For software and system functionality (data transmission, app features), ground truth would be established against documented functional requirements.
8. The sample size for the training set:
- Not applicable/Not provided. The document describes a "sensor" and "system" that perform specific functions (recording actuations, transmitting data, providing reminders), rather than a machine learning or AI model that requires a training set in the typical sense.
9. How the ground truth for the training set was established:
- Not applicable/Not provided, as there is no mention of a training set for an AI/ML 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).