(31 days)
The Asthmapolis System includes the Asthmapolis Sensor which is an electronic accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage.
The Asthmapolis Mobile Application records, stores, and transmits usage events from the Asthmapolis Sensor to a remote storage system.
The Asthmapolis Web Application is software intended to allow users to review the collected information and characteristics of MDI use, to add detail associated with a recorded usage event, and to share that information with their physician in order to provide additional information associated with the condition for which their MDI medication(s) are prescribed.
The Asthmapolis System may also be used in clinical trials where researchers need to know information about use of a MDI Medication(s) by a participant.
The output of the Asthmapolis System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Asthmapolis system is not intended for use as a MDI medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI.
Electronic MDI Accessory
The Asthmapolis System is an electronic accessory device (Asthmapolis Sensor) paired with a mobile and web application. Its intended use is to record and monitor actuations of prescribed Metered Dose Inhaler (MDI) usage for physicians and patients, and for use in clinical trials to track MDI medication use. It is not intended for diagnosis, as a MDI dose counter, or to indicate remaining medication.
The device was determined to be substantially equivalent to the SmartTrack System (K091803).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Functional Verification & Performance (MDI Actuation Sensor) | "Non-clinical testing has been carried out to cover functional verification and device performance. This included completion of software verification and validation procedures, with performance testing of the MDI actuation sensor system to ensure data is logged accurately for MDI usage. This established correct functionality of the Asthmapolis System according to the requirements." |
| Software Verification & Validation | "Test results indicate that the Asthmapolis System complies with its predetermined specifications." |
| Electrical Safety (IEC 60601-1) | "The Asthmapolis Sensor has successfully completed patient safety testing according to IEC 60601-1." |
| Electromagnetic Compatibility (IEC 60601-1-2) | "The Asthmapolis Sensor has successfully completed EMC testing according to IEC 60601-1-2." |
| Wireless/Bluetooth Technology Performance | "The Asthmapolis System has successfully completed performance testing... for wireless/Bluetooth technology in accordance with specifications and also with, 'FDA's Guidance on Radio-Frequency Wireless Technology in Medical Devices'." Also, "tests required for FCC licensing were successful." |
| Equivalence to Predicate Device | "This information indicates that the Asthmapolis System is equivalent to the predicate device in terms of device safety and effectiveness. Based upon this comparison of the predicate, and the accompanying testing results for the Asthmapolis System, the Asthmapolis System is substantially equivalent to the predicate device." |
| Biocompatibility, Cleaning Validation | "The Asthmapolis System also meets standard requirements for... biocompatibility, cleaning validation..." (No specific performance details provided in the summary, just a statement of compliance). |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes non-clinical performance and engineering testing (software, electrical safety, EMC, wireless). It does not mention a "test set" in the context of patient data or clinical data. The performance testing appears to be primarily bench testing and software validation. Therefore, there is no information provided regarding a sample size for a test set of patient data, nor its provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
As the testing described is primarily non-clinical (bench, software, electrical), the concept of "ground truth" derived from expert review in a clinical context does not apply here. The "ground truth" would be related to engineering specifications and functional requirements. Therefore, no information on the number or qualifications of experts for establishing ground truth for a clinical test set is provided.
4. Adjudication Method for the Test Set
Given that the document describes non-clinical, bench, and software testing, a clinical "adjudication method" like 2+1 or 3+1 is not relevant. The verification and validation processes would involve reviewing test results against predefined specifications and requirements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device's primary function is to automatically record MDI actuations, not to aid human readers in interpreting clinical images or data in a way that would necessitate an MRMC study. The comparison is between the performance of the Asthmapolis System and its predicate device (SmartTrack System) in terms of fundamental technological characteristics and safety.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
The performance testing described focuses on the standalone functionality of the device components:
- MDI actuation sensor system: "to ensure data is logged accurately for MDI usage."
- Software verification and validation: "device features are effective, and that the system configuration functions equivalently to the predicate device."
- Wireless/Bluetooth technology: "successfully completed performance testing... in accordance with specifications."
These tests evaluate the device's ability to perform its specified functions independently (e.g., accurately detecting an MDI actuation and transmitting data). While the system is intended to assist physicians and patients, the core performance validation relates to the device's inherent functional accuracy rather than its human-in-the-loop impact. So, yes, the described performance testing reflects a standalone evaluation of the device's core functionalities.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical tests would be:
- Engineering Specifications/Requirements: For functional verification, software validation, electrical safety, EMC, and wireless performance, the "ground truth" is defined by the established technical specifications and performance requirements derived from applicable standards (e.g., IEC 60601-1, IEC 60601-1-2, FDA guidance for wireless technology) or internal design documentation.
- Predicate Device Performance: For demonstrating substantial equivalence, the "ground truth" for comparative technological characteristics is the known performance and characteristics of the legally marketed SmartTrack System (K091803).
In summary, the ground truth is based on engineering specifications, regulatory standards, and the characteristics of the predicate device's performance.
8. The Sample Size for the Training Set
The document describes non-clinical verification and validation testing, not a machine learning model that would require a "training set" in the sense of a large dataset for algorithm development. Therefore, no information is provided regarding a sample size for a training set. The "training" here refers to the software development process aligned with specific guidelines.
9. How the Ground Truth for the Training Set Was Established
As there's no mention of a traditional machine learning "training set" in this context, the question of how its ground truth was established is not applicable. The software development process followed established guidelines ("Design Control Guidance for Medical Device Manufacturers," "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," "Guidance for Off the Shelf Software Use in Medical Devices," and "General Principles of Software Validation"), which define the "ground truth" for compliant and effective software.
§ 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).