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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 MasterScope / MasterScope ECG is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow volume measurements. Mostly it will be used for COPD and Asthma patients.

In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on the screen or printed on paper. 12-channel ECG's are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.

MasterScope / MasterScope ECG can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. MasterScope / MasterScope ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. MasterScope / MasterScope ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients.

MasterScope CT (Clinical Trial version) incorporates the identical measurements. In addition it offers workflow control elements to restrict the use of the equipment (e.g. individual access rights are defined for different user roles like investigator, doctor, study nurse, trainer and service personnel).

The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm.

A qualified physician has to reassess all MasterScope / MasterScope ECG measurements. An interpretation by MasterScope ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the MasterScope / MasterScope ECG represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.

The MasterScope / MasterScope ECG / MasterScope CT is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.

MasterScope / MasterScope ECG is an active device providing following characteristics:

Mains operation Personal Computer System Graphic user interface Windows XP Professional LAB Software Powerful database for storing patient- and test data

Ultrasonic handle Pneumotach handle/shutter ECG Amplifier

pulmonary functions a)

• Measurement with ultrasonic handle or pneumotach handle .
• Slow spirometry (VCin, VCex, VCmax, ERV, IC, VT, IRV, MV, BF, TI, TE, ... ) .
• Forced spirometry (FVCin, FVC, FEV1, PEF, FEV1/FVC, FEF 50, FEF 75, PIF, ... ) .
• Flow-Volume and Volume- Time Loop, pre/post tests
• MV measurement
• R Occlusion (only with pneumotach handle)
• Trending capabilities .
• Patient Incentive animations
• Interpretation modules .

b) ECG functions

• Simultaneous acquisition of the 12 standard leads .
• Storage of 10 seconds of acquired ECG signal
• Digital filters for base-line drift and mains interference suppression .
• Interpretation program Hanover ECG System (HES) providing the following additional information:
• Representatives templates of each lead including markers on fiducially points .
• Summary of mean measurements
• Rhythm Analysis statements .
• Signal noise detection and information
• Specific findings on QRS complex .
• Conduction statements .
• QRS T diagnostic statements .
• Arrhythmia monitoring detection .
• Heart Rate Variability

The provided text describes a 510(k) summary for the MasterScope, MasterScope ECG, and MasterScope CT devices. However, this document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the general safety and development practices. There is no information provided regarding specific acceptance criteria, a detailed study proving device performance against these criteria, or any of the detailed aspects of a clinical study (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies).

The text mentions "Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards" and that "The software was developed according to the IEC 601-1-4 Standard" and "The EMC testing was performed according EN 60601-1-2." These are general statements about compliance with standards and safety testing, not a detailed performance study against specific acceptance criteria for the device's functional performance (e.g., accuracy of ECG interpretation or spirometry measurements).

Therefore, I cannot populate the requested table and answer many of the questions based on the provided input.

Here's what can be inferred and what is missing:

Acceptance Criteria and Device Performance

Study Information (Based on available information in the document)

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

   • Not specified. The document does not describe a specific clinical test set or its characteristics. It mentions the "MasterScope CT (Clinical Trial version)" but does not provide details of any clinical trial or performance study.

2. 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 specified. No information is provided about experts or ground truth establishment for a test set.

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

   • Not specified. No information for a test set is provided.

4. 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:

   • No such study is mentioned or described. The device includes "Interpretation modules" for spirometry and an "Interpretation program Hanover ECG System (HES)" for ECG. The ECG interpretation states: "A qualified physician has to reassess all MasterScope ECG measurements. An interpretation by MasterScope ECG is only significant if it is considered in connection with other clinical findings." This implies the AI provides suggestions that are meant to be reviewed by a human, but no MRMC study comparing performance with and without AI assistance is described.

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

   • Not explicitly stated for performance metrics. While the device has automated interpretation features, the document emphasizes that a physician must reassess the measurements, suggesting it's not intended for standalone diagnostic use. No specific standalone performance study results are provided.

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

   • Not specified.

7. The sample size for the training set:

   • Not specified. No information about a training set for any embedded algorithms (like the HES interpretation program) is provided.

8. How the ground truth for the training set was established:

   • Not specified.

Summary of Missing Information:

The provided 510(k) summary focuses on the technical specifications of the MasterScope devices (pulmonary function and ECG), their intended use, and a comparison to predicate devices to establish substantial equivalence. It confirms adherence to general safety and design control standards. However, it does not include the detailed performance study information typically associated with establishing specific acceptance criteria and proving device performance through clinical or algorithmic validation tests for features like automated ECG interpretation or precise spirometry measurements.

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