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MasterScope WSSU is a medical device to measure inspiratory and expiratory lung function parameters. With the option ECG a 12-channel surface electrocardiogram (ECG) can be measured and recorded. It 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.

A qualified physician has to reassess all MasterScope/MasterScope ECG measurements. An interpretation by MasterScope/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 quantitative information on the patient's cardiovascular conditions and no therapy or drugs can be administered based solely on the interpretation statements.

It can be used by physicians in the office or hospital.

The MasterScope spirometry and ECG application is intended to measure adults and children aged 4 years and older. The patients must be able to understand and perform instructions of the physician.

The MasterScope is a portable device, which can collect spirometry and ECG data.

With the option Spirometry, inspiratory and expiratory lung function measurements can be performed with a wired sensor (Digital Handle USB) or wireless spirometry sensor unit (WSSU Bluetooth). Both spirometry sensors work with a pneumotach (Lilly Type Pneumotachograph).

The Wireless Spirometry Sensor Unit is battery-powered and can be charged with a dedicated charging station.

With the option ECG, a 12-channel surface electrocardiogram (ECG) can be measured and recorded. It is not intended for intracardial use.

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

The MasterScope software allows protocol-driven workflows and can be customized for use in clinical trials (e.g. individual access rights).

MasterScope provides automated and secure data transmission to a centralized data base.

The measured data is saved into the MasterScope software and can be read out at any time.

A printer can be connected with the notebook and all needed data can be printed. Moreover it is possible to transfer data by USB, Wifi, and Ethernet.

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

The provided text describes the MasterScope WSSU device and its substantial equivalence to predicate devices, focusing on spirometry and ECG functions. The information relevant to acceptance criteria and study proving device performance is primarily found in the "Summary Table of Comparison" (pages 7-8) and "Summary of Device Testing" (page 12).

Here's an analysis of the provided information against the requested points:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides performance specifications for the pulmonary function measurements, which serve as acceptance criteria.

Pulmonary Function Performance Comparison

Note: The MasterScope WSSU is stated to have identical performance specifications to the reference device (SpiroSphere K173937), meaning it meets the established acceptance criteria. The document explicitly states "The Sensor Unit used in MasterScope WSSU device is cleared under SpiroSphere (K173937). The Sensor Unit is supplied in its final finished form and is identical to the reference predicate device." and lists the exact same performance specifications for the MasterScope WSSU as for SpiroSphere in the comparison table.

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample size used for the test set in the context of clinical performance evaluation (e.g., number of patients or spirometry maneuvers). Instead, it refers to

• "Tests were performed to confirm that the MasterScope WSSU meets the recommendations for accuracy and precision for Spirometry of the American Thoracic Society (ATS) according to ATS/ERS standards 2005." (page 12)
• "The Sensor Unit used in MasterScope WSSU device is cleared under SpiroSphere (K173937). The Sensor Unit is supplied in its final finished form and is identical to the reference predicate device." (page 7)

This suggests that the performance evaluation relies heavily on the prior clearance of the identical sensor unit within the SpiroSphere device, which would have undergone its own testing.
The document does not specify the country of origin of data or whether it was retrospective or prospective for the current submission's testing. It seems to leverage existing data/clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The spirometry performance is based on ATS/ERS standards, which are objective technical standards rather than expert consensus on individual cases. For the ECG interpretation, the device uses the "Hannover ECG system (HES)", but the document notes: "A qualified physician has to reassess all MasterScope/MasterScope ECG measurements. An interpretation by MasterScope/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 quantitative information on the patient's cardiovascular conditions and no therapy or drugs can be administered based solely on the interpretation statements." This indicates that the device's ECG interpretation is supportive, not definitive, and requires physician oversight. Therefore, direct expert ground truth establishment for a test set, as might be done for an AI diagnostic device, is not thoroughly described here.

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

This information is not provided. Given the nature of objective performance testing against standards rather than subjective human interpretation, a formal adjudication method as typically seen in image-based AI studies (e.g., 2+1 radiologist reads) is generally not applicable or described for this type of device.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study involving human readers with and without AI assistance was not mentioned or described. This device appears to be a measurement tool with an interpretation assist (for ECG), not a primary AI diagnostic tool where human-AI interaction is the core subject of evaluation. The primary focus of the submission is demonstrating substantial equivalence through technical performance and component identity.

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

The device's performance specifications (Accuracy and Resolution) for spirometry are for the device itself, implying standalone performance. For ECG, the device uses the "Hannover ECG system (HES)" which provides "interpretation statements." However, the text explicitly states that "Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients," and "A qualified physician has to reassess all MasterScope/MasterScope ECG measurements." This suggests that even for ECG, the algorithm's output is not intended to be "standalone" without human-in-the-loop, emphasizing a supportive role. The technical performance metrics listed for spirometry are inherent to the device's measurement capabilities.

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

For spirometry, the ground truth is against ATS/ERS standards 2005 for accuracy and precision. These are widely accepted objective technical standards for pulmonary function testing equipment.
For ECG, the "Hannover ECG system (HES)" provides interpretation statements. The implicit ground truth for such systems would typically involve a large dataset of ECGs with confirmed diagnoses (often by expert cardiologists or based on outcomes), but the document does not detail how HES's accuracy was validated or what constituted its ground truth in this submission. The submission focuses on the HES being part of the predicate device.

8. The sample size for the training set:

The document does not provide information regarding the sample size for a training set. This is not a typical AI/ML device where specific training datasets are detailed in this manner. The device is primarily a measurement instrument, and its software (including HES) is presumably developed based on established algorithms rather than contemporary machine learning models that require large labeled training sets as a distinct part of the clearance process for new devices.

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

Since no specific "training set" and its size are mentioned, the method for establishing its ground truth is also not provided. The device is categorized as a "Predictive pulmonary-function value calculator" but operates on established physiological measurement principles and computations. The ECG interpretation component (HES) is a "black box" in terms of its internal development and training, leveraging its prior clearance within the predicate device.

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