(70 days)
The Asthma Monitor AM1+ / AM1+ BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM1+ / AM1+ BT measures the flow during expiration serving for the calculation of further parameters as FEV1.
The AM1+ / AM1+ BT is used to monitor the respiratory status of human beings in the areas 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 selected parameters (e.g. PEF, FEV1). Furthermore a visual control unit, displayed as a kind 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. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life" status. When enabled, the AM1+ / AM1+ BT can be programmed with a couple of questions, where the patient can select then from a couple of different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS.
The AM1+ / AM1+ BT is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM1+ / AM1+ BT being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.
The AM1+ operates with serial data transmission whereas the AM1+ BT can be operated with serial and Bluetooth data transmission.
The Asthma Monitor AM1+ / AM1+ BT is a medical device (peak flow meter with symptom diary) providing following characteristics:
- Handheld device .
- Battery operation .
- Storing capacity of 400 measurements / 2000 entries .
- Measurement Parameters: PEF and FEV1 .
- Accuracy Flow: ± 5% or ± 20 l/min .
- Accuracy Volume: ± 3% or ± 0.05 liter .
- Data transmission to computer via Bluetooth and Serial (AM1+ BT) .
- Data transmission to computer via Serial (AM1+) .
- Flow sensor (single patient use) .
- Mouthpiece (single patient use) .
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document, K090486, focuses on demonstrating substantial equivalence to a predicate device (Asthma Monitor AM2, K980676) rather than presenting specific acceptance criteria and performance data for the Asthma Monitor AM1+ / AM1+ BT. The summary highlights that the new device performs "at least as well as the predicate devices" based on the tests conducted.
However, based on the "Device Description" on page 2, the following performance specifications for the PM1+/PM1+ BT are stated, which implicitly serve as acceptance criteria that the device must meet:
| Acceptance Criteria (from Device Description) | Reported Device Performance (from Device Description) |
|---|---|
| Accuracy Flow: ± 5% or ± 20 l/min | ± 5% or ± 20 l/min |
| Accuracy Volume: ± 3% or ± 0.05 liter | ± 3% or ± 0.05 liter |
| Storing capacity of measurements | 400 measurements / 2000 entries |
| Measurement Parameters | PEF and FEV1 |
The document does not elaborate on how these specific accuracy criteria were assessed or explicitly state "reported performance" as a distinct section for these values in reference to a specific study. Instead, the "Summary of Device Testing" section broadly states that "Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards," implying these performance characteristics were verified.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective or prospective) for performance evaluation. The testing described is primarily focused on design control and safety, not a clinical performance study with a defined test set of patients.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not mention the use of experts to establish ground truth for a test set. This type of device (diagnostic spirometer) typically relies on objective physical measurements rather than expert interpretation for ground truth.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned as there is no described test set involving human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. The device is a diagnostic spirometer for objective measurement, not an AI-assisted diagnostic tool requiring human-in-the-loop performance evaluation in an MRMC setting.
6. Standalone Performance Study:
A standalone performance study for the algorithm (the underlying measurement and calculation engine) is implicitly indicated by the stated "Accuracy Flow" and "Accuracy Volume" specifications. These are inherent performance characteristics of the device's measurement capabilities. However, specific details of such a study (e.g., methodology, sample size, conditions) are not provided in the summary. The document mentions "Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards," which can be interpreted as part of standalone testing.
7. Type of Ground Truth Used:
The ground truth for the performance of a diagnostic spirometer like the Asthma Monitor AM1+ / AM1+ BT would typically be established through reference standards or highly accurate laboratory calibration equipment for flow and volume measurements, rather than expert consensus, pathology, or outcomes data, which are relevant to image-based diagnostics or clinical efficacy. The document does not explicitly state the ground truth method, but this is the standard for such devices.
8. Sample Size for the Training Set:
The document does not mention a training set or its sample size. This device is a measurement device with a specific algorithm for calculating parameters like PEF and FEV1, not a machine learning or AI device that typically involves a "training set."
9. How Ground Truth for the Training Set Was Established:
As there is no mention of a training set, the method for establishing its ground truth is not applicable or described.
§ 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).