(290 days)
The Asthma Monitor AM3 G+ is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever there is a need of. The AM3 measures the flow during expiration serving for the calculation of further parameters as FEV 1.
The AM3 is used to monitor the respiratory status of human beings (adults and children 5 years and older) in the areas of asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management.
The patient is informed of the results by numeric values for the selected parameters (e.g. PEF, FEV ). Furthermore, a visual control unit, displayed in the form of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician.
The device saves the results of a measurement (always with date and time) automatically in an internal database. In addition, (symptom and medications) questionnaire functionality can be called up by the use of a software (AMOS) to record e.g. the "Quality of Life"status.
When enabled, the AM3 can be programmed with a couple of questions, where the patient can then select from a couple of different answers. This information is also stored in the internal database and can be transmitted for evaluation using the software AMOS.
The AM3 is designed to replace an ordinary peak flow meter, diary and pencil by a single system. The asthma monitor AM3 is intended to be used in health care, clinical and home use environments.
The Asthma Monitor AM3 G+ is a medical device (peak flow meter with symptom diary) providing following design and performance characteristics:
- Handheld device
- Battery operation
- Storing capacity of 1200 measurements
- Storing capacity of 400 sets of questionnaires (max. 20 questions each)
- Measurement Parameters: PEF and FEV1
- Accuracy Flow: ± 5% or ± 20 I/min
- . Accuracy Volume: ± 3% or ± 0.05 litre
- Wireless communication with computer/mobile device/database via Bluetooth and mobile communication (3G, TCP/IP) by using accessory software AMOS
- . Rotary Flow Sensor (single patient use)
The Asthma Monitor AM3 G+ is an instrument that combines a peak flow meter with a symptom and medication diary. This device displays questions concerning symptoms and medication to be answered twice a day and measures and evaluates the Peak Flow (PEF = Peak Expiratory Flow [l/min]) and FEV1 (Forced Expiratory Volume in 1 second [1]).
The AM3 G+ keeps a diary of patient measurements by automatically recording all answers and PEF measurements with the date and time in its memory. Data can be collected for approximately 100 days. Every time the patient visits the centre, the data will be downloaded by using AMOS software. Additionally the data can be exchanged to a predefined database using the 3G mobile communication module (SMS, TCP/IP).
Scheduled sessions, including questionnaire and PEF measurements, can be configured wirelessly using AMOS software, performed and stored with the AM3 G+. Following the study protocol, the patient has to carry out scheduled sessions twice a day.
In the morning and the evening session, there is a set of questions to be answered before a scheduled PEF measurement can be performed. As soon as the patient switches on the AM3 G+ for the first time during one of the time windows, the first question of the appropriate questionnaire will be displayed.
AMOS is a stand-alone software for the professional user (physician/clinical staff) for configuration, parameter processing and data display. It does not provide a diagnosis or treatment suggestions. Diagnosis and appropriate therapeutic treatments are only made by the physician. The AMOS software allows to set and adjust individual thresholds which are based on international and national standards such as ATS and ERS. They are based on the patient's individual best value which is determined by the doctor.
The provided text describes the Asthma Monitor AM3 G+ device and its substantial equivalence determination by the FDA. However, it does not contain detailed information regarding the acceptance criteria for a specific study that proves the device meets those criteria, especially in the context of an AI/ML-driven device with complex performance metrics often seen in such submission.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Asthma Monitor AM3 GSM K133722) by highlighting similar intended use and comparable technological characteristics, as well as adherence to various performance, safety, and regulatory standards.
Here's an analysis of the requested information based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document mentions accuracy and precision for spirometry according to ATS/ERS 2005 standards. It lists the following performance parameters for both the predicate and the subject device:
| Acceptance Criteria (ATS/ERS 2005 standards) | Reported Device Performance (Asthma Monitor AM3 G+) |
|---|---|
| PEF: ± 5% or ± 20 l/min | PEF: ± 5% or ± 20 l/min |
| FEV1: ± 3% or ± 0.05 liter | FEV1: ± 3% or ± 0.05 liter |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "No clinical testing is required." and refers to "Performance Testing" which seems to be laboratory-based verification and validation. Therefore, a "test set" in the context of clinical data or patient samples is not explicitly mentioned as being used for this submission. The data provenance is not specified beyond the fact that the company is located in Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. As no clinical testing was required, there's no mention of experts establishing ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided because no clinical test set requiring adjudication is mentioned.
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
This information is not provided. The device described is a diagnostic spirometer with a symptom diary, not an AI-assisted diagnostic tool that would typically involve human readers or MRMC studies for improved performance. The "clinical staff" mentioned in the description of AMOS software are professional users, but their interaction with an AI component for diagnostic improvement is not discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone electronic measurement device. The performance data provided (PEF and FEV1 accuracy) represents the algorithm's (or device's) standalone measurement capabilities. The AMOS software processes and displays data but does not provide diagnosis or treatment suggestions; these are made by the physician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the accuracy and precision measurements (PEF and FEV1), the ground truth would typically be established by highly accurate reference spirometry equipment or calibrated flow/volume simulators, adhering to standards like ATS/ERS. However, the document does not explicitly detail the method for establishing this "ground truth" for the performance tests, beyond stating adherence to ATS/ERS standards.
8. The sample size for the training set
This information is not applicable and not provided. The Asthma Monitor AM3 G+ is a traditional medical device (spirometer) and not explicitly described as an AI/ML device that requires a training set in the conventional sense. The "training" of the device likely refers to its calibration and validation against established standards.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as the device is not described as an AI/ML product requiring a "training set" with established ground truth in the AI context.
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).