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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:

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.

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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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The Asthma Monitor AM3 / AM3 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 AM3 / AM3 BT measures the flow during expiration serving for the calculation of further parameters as FEV1.

The AM3 / AM3 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 AM3 / AM3 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 AM3 / AM3 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 AM3 / AM3 BT being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.

The Asthma Monitor AM3 is a medical device (peak flow meter with symptom diary) providing following characteristics:

• Handheld device
• Battery operation
• Storing capacity of 400 measurements
• Storing capacity of 200 sets of questionnaires (each 12)
• Measurement Parameters: PEF and FEV1
• Accuracy Flow: ± 5% or ± 20 l/min
• Accuracy Volume: ± 3% or ± 0.05 liter
• Data transmission to computer via USB, Bluetooth and Serial
• Flow sensor (single patient use)
• Mouthpiece (single patient use)

The provided document is a 510(k) Summary for the Asthma Monitor AM3 / AM3 BT. This submission primarily focuses on demonstrating substantial equivalence to a predicate device, particularly regarding the addition of Bluetooth data transmission. It is not an effectiveness study as typically performed for novel algorithms or diagnostic devices.

Therefore, many of the requested categories for a study proving device performance, especially those related to clinical accuracy, ground truth, and expert evaluation, are not applicable in this context. The document describes engineering and regulatory compliance testing rather than clinical performance studies.

Here's a breakdown of the information that can be extracted or that is not applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance specifications and indicates that safety and EMC testing was conducted for the modified device, but it doesn't present a table of acceptance criteria and reported device clinical performance in the way this question typically implies for diagnostic algorithms.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This submission focuses on engineering modifications (adding Bluetooth) and demonstrating equivalence to existing devices, not on a clinical performance study with a "test set" of patient data for algorithm evaluation in the way the question implies. The testing done was likely functional and safety testing of the device hardware and software.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No ground truth establishment by medical experts for a test set is described or required for this type of 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is relevant to this submission.

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 is not an AI/algorithm-focused submission. It's for a diagnostic spirometer with an added data transmission method (Bluetooth).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a measurement device (spirometer), not a standalone algorithm/AI without human input. Its function is to provide quantifiable measurements (PEF, FEV1) to the patient and physician.

7. The Type of Ground Truth Used

Not applicable. Ground truth, in the context of clinical accuracy or diagnostic performance, is not discussed as this submission focuses on device equivalence and safety for a new data transmission method. The "truth" for the device's measurements would be established through mechanical calibration and validation against known standards, not by expert consensus on clinical cases.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set is mentioned or relevant to this submission.

Summary of the Study Discussed in the Document:

The "study" described in the 510(k) summary is primarily engineering and regulatory compliance testing to support a Special 510(k) submission for a device modification (adding Bluetooth data transmission).

The key elements are:

• Objective: To demonstrate substantial equivalence of the Asthma Monitor AM3 with Bluetooth (AM3 BT) to its predicate device (Asthma Monitor AM3 K980876/A2) and a similar predicate with Bluetooth (Asthma Monitor AM1+ / AM1+ BT K090486), specifically for the added Bluetooth functionality.
• Methodology:
  • Comparison: A direct comparison table shows the characteristics of the new AM3 BT against the original AM3 and the AM1+ BT. The critical point is that the Bluetooth module in the AM3 BT is identical to the one used in the already cleared AM1+ BT.
  • Development Standards: The Bluetooth data transmission was developed in accordance with Cardinal Health's standard operating procedures (Design Control).
  • Risk Analysis: A Failure Modes and Effects Analysis (FMEA) was performed to assess the impact of the added Bluetooth.
  • Safety Testing: Procedures were followed to demonstrate satisfaction of all safety requirements and mitigation of identified hazards.
  • EMC Testing: Performed according to EN 60601-1-2.
  • Software Development: Followed IEC 601-1-4 Standard.
• Conclusion: Based on these engineering and regulatory compliance measures, the submitter concluded that the Asthma Monitor AM3 with the "Bluetooth" data transmission module is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use, performing at least as well as the predicate devices.

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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:

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.

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The Asthma Monitor AM2 from JAEGER 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 AM2 measures the flow during expiration serving for the calculation of further parameters as FEV1, FVC or FEF25-75.

The AM2 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, FEVI). 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 AM2 can be programmed with up to 12 questions, where the patient can select then from up to 7 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 AM2 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 AM2 being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.

The Asthma Monitor AM2 from JAEGER 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 AM2 measures the flow during expiration serving for the calculation of further parameters as FEV1, FVC or FEF25-75.

The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEVI). 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 AM2 can be programmed with up to 12 questions, where the patient can select then from up to 7 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 AM2 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 AM2 being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.

The provided document (K980876) is a 510(k) clearance letter for the "Asthma Monitor AM2" and an "Indications For Use" statement. It does not contain a study describing acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications for a clinical study as requested.

The document indicates that the device is substantially equivalent to legally marketed predicate devices, which means its safety and effectiveness were likely established based on its similarity to existing devices, rather than a new standalone clinical study with detailed acceptance criteria and performance metrics.

Therefore, I cannot provide the requested information from this document.

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