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The Asthma Monitor AM3/AM3 GSM is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever there is a need of. The AM3 measures the flow during expiration serving for the calculation of further parameters as FEV1.

The AM3 is used to monitor the respiratory status of adult human beings 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, FEV1). 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, 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 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 to a standard PC using the software package AMOS.

The AM3 is designed to replace an ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM3 to be used in healthcare, clinical and home use environments/settings.

The Asthma Monitor AM3 GSM is a medical device (peak flow meter with symptom diary) providing following 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 1/min
• Accuracy Volume: ± 3% or ± 0.05 liter
• Data transmission to computer/database via USB, Bluetooth, GSM and Serial (RS232)
• Flow sensor (single patient use)
• Mouthpiece (single patient use)

The provided text describes a Special 510(k) submission for a device called the Asthma Monitor AM3 GSM, which is a modification of an existing device (Asthma Monitor AM3/AM3 BT, K092890). The key modification is the addition of GSM functionality for data transfer and a Li-Ion battery.

The document focuses on demonstrating that the modified device is substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness, rather than demonstrating that the device meets specific performance acceptance criteria for diagnostic accuracy through a clinical study.

Therefore, most of the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth, expert opinions, and comparative effectiveness studies is not directly available or applicable in the provided text in the context of typical AI/diagnostic device clinical study reporting. The submission is primarily about demonstrating the safety and effectiveness of a feature addition (GSM data transfer and a new battery type) to an already cleared device, not a new diagnosis or interpretation algorithm.

Here's a breakdown of the specific points based on the available text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document implies the acceptance criteria are related to maintaining the performance (accuracy of flow and volume measurements) and safety standards of the predicate device, while demonstrating the safe and effective integration of the new features (GSM data transfer and Li-Ion battery). Specific quantitative performance criteria for the diagnostic function (e.g., sensitivity, specificity for a diagnostic claim) are not explicitly stated as this is a device modification submission for a spirometer, not a new diagnostic algorithm.
  • The predicate device's performance regarding "Accuracy Flow: ± 5% or ± 20 1/min" and "Accuracy Volume: ± 3% or ± 0.05 liter" could be considered the baseline performance that the modified device is expected to maintain, but it's not explicitly stated as an "acceptance criterion" for this specific submission's new features.
• Reported Device Performance: The document states:
  • "The device performance is not affected by adding the GSM function, as the data transfer is offline and will not take place when a measurement is active or a questionnaire is performed."
  • "The wireless transfer is based on the use of the GSM module Sierra Wireless WISMO288. The GSM module uses techniques to guarantee the integrity of the transferred data. Latency and throughput is part of the GSM module implementation. The use of the qualified GSM module ensures that the latency and throughput requirements were met."
  • "The Li-Ion battery and the power supply fulfil the common standards and were implemented and tested for safe and effective use."
  • "Based on the above, eResearchTechnology concludes that the Asthma Monitor AM3 with the "GSM" data transmission module does not raise new questions of safety and effectiveness and is as safe and as effective for its intended use, and performs at least as well as the predicate devices."

Summary Table of (Relevant) "Acceptance Criteria" and Reported Performance (Inferred from the text):

The following points (2-9) are largely not applicable or not detailed in this specific type of 510(k) submission, as it focuses on demonstrating substantial equivalence for a device modification (adding connectivity and a new battery), not on a new diagnostic algorithm's performance against a ground truth in a clinical study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not specified/Applicable: The document does not describe a test set or data provenance for a diagnostic performance study. The testing described is primarily engineering and software verification/validation (EMC testing, GSM module testing, software development, safety test procedures).

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)

• Not applicable: No ground truth establishment for a test set is discussed, as this is not a diagnostic accuracy study for a new algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable: No test set or adjudication method for diagnostic results 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

• Not applicable: This device is a spirometer for measuring lung function and assisting in monitoring, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable: The device is a measurement device (spirometer), not an AI algorithm. Its performance is inherent in its physical measurement capabilities. The "algorithm" mentioned refers to the software controlling the device and its data handling, not a diagnostic interpretation algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable: No diagnostic ground truth is discussed. The device measures physical parameters (PEF, FEV1). The "ground truth" for its accuracy would relate to comparisons against calibrated reference standards for flow and volume.

8. The sample size for the training set

• Not applicable: There is no mention of a training set, as this is not an AI/machine learning submission.

9. How the ground truth for the training set was established

• Not applicable: No training set or ground truth establishment for it is discussed.

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