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The SpiroSphere is a compact device inspiratory and expiratory lung function parameters in adults and children aged 4 years and older. It can be used by physicians in the office or hospital.

With the option ECG, electrocardio measurements can be made under resting conditions. For this purpose a 12channel surface electrocardiogram can be measured and recorded. The acquired ECG can be displayed on the screen or printed on paper. The interpretation software is intended to support the physician in evaluation of the resting ECG in terms of morphology and rhythm. Automatic interpretation of the ECG is not possible for pediatric subjects with an age below 16 years and for pacemaker subjects. It is not intended for intra-cardial use.

A qualified physician has to reassess all ECG measurements. An interpretation by SpiroSphere ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the SpiroSphere 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 SpiroSphere ECG is not intended for use in an EMS environment (Emergency Medical Services Environment).

The minimum age for ECG application is 4 years.

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

With the CardioSphere, electrocardio measurements can be made under resting conditions. For this purpose a 12channel surface electrocardiogram can be measured and recorded. The acquired ECG can be displayed on the screen or printed on paper. The interpretation software is intended to support the physician in evaluation of the resting ECG in terms of morphology and rhythm. Automatic interpretation of the ECG is not possible for pediatric subjects with an age below 16 years and for pacemaker subjects. It is not intended for intra-cardial use.

A qualified physician has to reasurements. An interpretation by CardioSphere is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the CardioSphere represent partial qualitative and quantitative information on the patient's cardition and no therapy or drugs can be administered based solely on the interpretation statements. The CardioSphere is not intended for use in an EMS environment (Emergency Medical Services Environment).

The minimum age for ECG application is 4 years.

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

SpiroSphere is a compact spirometry device. Its Sensor Unit is batterypowered. The Main Unit can be powered by battery or power supply. The SpiroSphere / SpiroSphere ECG is used to measure inspiratory and expiratory lung function parameters in adults and children 4 years and older. The measured data is saved to the device and can be read out at any time.

SpiroSphere ECG is a compact spirometry device. Its Sensor Unit is battery-powered. The Main Unit can be powered by battery or power supply. The SpiroSphere / SpiroSphere ECG is used to measure inspiratory and expiratory lung function parameters in adults and children 4 years and older. The measured data is saved to the device and can be read out at any time.

With the ECG option (subject of this 510(k)), 12-channel surface electrocardiogram can be measured and recorded.

The Main Unit can be powered by battery or power supply. The Main Unit is wirelessly connected to an ECG amplifier via Bluetooth.

With the ECG option (subject of this 510(k)), 12-channel surface electrocardiogram can be measured and recorded.

A printer can be connected and data (e.g. reports, screenshots) can be printed. Moreover, it is possible to transfer data by USB. Wifi. 3G. and Ethernet connections.

Pulmonary function assessments

• Slow Spirometry .
• Forced Spirometry .
• Flow-Volume loop and Volume-Time tracing, pre/post tests ●
• Trending capabilities ●

Cardiovascular assessments

• 12 Lead Electrocardiogram ●

The provided text does not contain information about acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification letter from the FDA, along with a device description and comparison tables to predicate devices. It discusses general information about the device, its intended use, technological characteristics, and a summary of device testing (e.g., software verification, risk analysis, electrical safety, EMC, human factors, cybersecurity, reprocessing validation). However, it does not specify quantitative acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) for its interpretation software, nor does it detail a specific study proving these criteria were met.

Therefore, I cannot provide the requested information based on the given text.

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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

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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 SpiroSphere is a compact device to measure inspiratory and expiratory lung function parameters in adults and children aged 4 years and older.

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

The SpiroSphere is a compact spirometry device. It's Sensor Unit is battery-powered. The Main Unit can be powered by battery or power supply. The SpiroSphere is used to measure inspiratory and expiratory lung function parameters in adults and children 4 years and older. The measured data is saved into the device and can be read out at any time.

A printer can be connected with the SpiroSphere and all needed data (e.g. reports, Screenshots) can be printed. Moreover it is possible to transfer data by USB, Wifi, 3G, and Ethernet.

Pulmonary functions

• Slow Spirometry
• Forced Spirometry
• Flow-Volume loop and Volume-Time tracing, pre/post tests
• Trending capabilities

The provided text describes the SpiroSphere, a device for measuring lung function, and its substantial equivalence to a predicate device (SpiroPro). However, it does not contain the detailed information required to answer your specific questions about acceptance criteria and a study proving the device meets them.

The document is a 510(k) summary for premarket notification to the FDA. It focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing the detailed clinical or performance study results you're asking for.

Here's a breakdown of why the requested information is absent:

• Acceptance Criteria and Reported Device Performance (Table): The document states adherence to ATS/ERS standards (2005) for spirometry accuracy and precision and lists various parameters measured (FEV1, FVC, PEF, etc.). However, it does not provide a specific table of acceptance criteria (e.g., +/- x% accuracy) or numerical reported device performance against those criteria. It only generally states that "Tests were performed to confirm that the SpiroSphere meets the recommendations for accuracy and precision for Spirometry of the American Thoracic Society (ATS) according to ATS/ERS standards 2005."
• Sample Size, Data Provenance, Ground Truth Experts, Adjudication Method, MRMC Study, Standalone Performance, Training Set Sample Size/Ground Truth: These details are typically found in a dedicated clinical or performance study report, which is not included in this summary. The 510(k) summary only mentions general verification and validation activities and conformance to standards.

In summary, based only on the provided text, I cannot complete the table or answer the specific questions about the study details because that level of detail is not present in this FDA 510(k) summary.

The document discusses:

• Device Name: SpiroSphere
• Predicate Device: SpiroPro (K000648) and SpiroPro with BT (K092324)
• Intended Use/Indications for Use: To measure inspiratory and expiratory lung function parameters in adults and children aged 4 years and older, usable by physicians in office or hospital.
• Technological Characteristics: Uses a pneumotachograph (Lilly Type) for pressure to flow conversion, measures various parameters (FEV1, FVC, PEF, FEF25-75, VC, IC, ERV) conforming to ATS/ERS Spirometry Standards (2005).
• Testing Mentioned: Software verification and validation (IEC 62304), Risk analysis (ISO 14971), electrical safety (IEC 60601-1:2012), EMC (IEC 60601-1-2:2014), wireless technology (FDA Guidance 2013), Human Factors/Usability (IEC 62366), Biocompatibility (ISO 10993-1:2009, ISO 18562:2017), Cybersecurity (FDA Guidance 2014), Reprocessing (FDA Guidance 2015).

To answer your questions thoroughly, a complete performance study report would be required, which typically contains the specific data and methodologies.

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