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EasyOne Pro/LAB is designed for conducting lung function measurements in general or specialist practices or in hospitals.

EasyOne Pro/LAB can also be used in clinical settings in occupational medicine for performing lung function screenings or measurements.

EasyOne Pro/LAB is used to conduct lung function measurements on adults and children starting at age 4, except measurements of diffusing capacity of the lung based on CO (DLCO), which can be performed on adults and children starting at age 6.

The EasyOne Pro Respiratory Analysis System consists of two different device models: EasyOne Pro and EasyOne Pro LAB.

The EasyOne Pro Respiratory Analysis System devices are pulmonary function testing devices. Both EasyOne Pro Respiratory Analysis System device models provide Spirometry and Single Breath CO Diffusion (DLCO) tests including Lung Volume Parameters. The device model EasyOne Pro LAB additionally provides the Nitrogen Multiple Breath Washout (MBW) method. The EasyOne Pro Respiratory Analysis System devices meet the ATS recommendations for accuracy and precision for Spirometry, DLCO and MBW tests.

The EasyOne Pro Respiratory Analysis System devices can be used as a stand-alone system and can be connected to a network.

The EasyOne Pro Respiratory Analysis System devices use the following sensors: An ultrasonic flow sensor to measure flow velocity, volume and molar mass of the gases that the patient inhales and exhales; a molar mass sensor which determines the helium content of the respired air for the DLCO test and the nitrogen concentration for the multiple-breath washout (MBW) test; a CO sensor (EasyOne Pro) or a combined CO/CO₂ sensor (EasyOne Pro LAB) to determine CO and CO2 content in breathing gas; a temperature and humidity sensor to collect environmental data.

The EasyOne Pro Respiratory Analysis System devices are used in combination with test gases (DLCO gas for DLCO tests and O2 for MBW tests).

The EasyOne Pro Respiratory Analysis System devices are used in combination with the single-patient use breathing tube ndd Spirette. For DLCO and MBW tests, the additional single-patient use accessories, the ndd DLCO or FRC Barriettes, are used.

The single-patient use accessories prevent cross-contamination between patients. The Spirette prevents the passage of microorganisms into the inside of the flow sensor; the Barriettes prevent the passage of microorganisms into gas supply tubing.

The provided document is a 510(k) premarket notification for the EasyOne Pro Respiratory Analysis System. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence. The document summarizes the testing performed to ensure the modified device meets performance and safety standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the EasyOne Pro Respiratory Analysis System devices "meet the ATS recommendations for accuracy and precision for Spirometry, DLCO and MBW tests." While specific numerical acceptance criteria (e.g., ±X% accuracy) for each parameter are not explicitly listed in the provided text, the general acceptance criterion is compliance with ATS recommendations.

Note: The document states that "For the modified devices, some of the labelled specifications were updated to reflect the technical capabilities. No changes were made to the components the specifications relate to." This implies there might be specific numerical specifications in other documentation not provided here.

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document mentions "testing with humans" for Spirometry, DLCO, and MBW, but does not specify the numerical sample size for the human test set. It also mentions "Simulated Spirometry, DLCO and MBW testing."
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Not applicable / Not specified in the provided text. This device is a measurement system and its "ground truth" would generally be established by calibrated reference standards and established physiological measurements, rather than expert consensus on interpretive tasks.

4. Adjudication Method for Test Set

Not applicable / Not specified in the provided text. As noted above, the "ground truth" for this type of device (a physiological measurement system) is based on reference standards and calibrated instruments, not on human interpretation or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers improve with AI assistance, which is not relevant for a device that measures lung function clinically. The EasyOne Pro is a diagnostic measurement device, not an AI-based interpretive aid for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, the testing described appears to be a standalone performance evaluation of the device's measurement capabilities. The "Simulated Spirometry, DLCO and MBW testing" would assess the algorithm and hardware performance independently, and the "testing with humans" would validate its clinical measurement accuracy against the ATS recommendations. The device itself is designed to provide direct physiological measurements.

7. Type of Ground Truth Used

The ground truth for the EasyOne Pro Respiratory Analysis System is established by technical standards and physiological recommendations, specifically the "ATS recommendations for accuracy and precision for Spirometry, DLCO and MBW tests." This would involve:

• Calibrated reference standards: For simulated testing (e.g., known flow and volume signals, known gas concentrations).
• Established physiological measurement methods: When testing with human subjects, the device's measurements would be compared against expected values or other validated methods to confirm compliance with ATS standards.

8. Sample Size for Training Set

Not applicable / Not specified. This device is a measurement system, not a machine learning algorithm that requires a "training set" in the conventional sense of AI models. Its underlying principles are based on known physics and physiological models, not data-driven learning from previous cases.

9. How Ground Truth for Training Set Was Established

Not applicable. As explained above, the device does not use a "training set" in the context of an AI/ML model. Its design and calibration are based on established scientific principles and engineering practices to meet specific performance standards.

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The ndd EasyOne Pro Respiratory Analysis System is designed for conducting lung function measurements in general or specialist practices or in hospitals. The EasyOne Pro Respiratory Analysis System can also be used outside of the laboratory when performing lung function screenings or measurements in occupational medicine. The EasyOne Pro Respiratory Analysis System is used to conduct slow and forced spirometry on adults and children starting at age 4. Measurement of Diffusing Capacity of the lung based on CO (DLCO) can be performed on adults and children starting at age 6.

The ndd EasyOne Pro Respiratory Analysis System is a portable device for performing lung function measurements such as spirometry and diffusion capacity (DLCO) tests. Measured lung function parameters can be compared to predicted normal values that are computed based on gender, age, and body height of the patient; the applied equations are available in literature and/or published standards. The device consists of a compact main unit and a hand-held sensor. Spirometry tests can be performed by connecting the hand-held sensor to the main unit. In order to perform DLCO tests a valve unit must additionally be connected to the hand-held sensor. The valve unit is connected with the main unit with a gas supply tube. The spirette respiratory tube is a mouthpiece for single patient use, which is inserted in the sensor. In the valve unit there is also an accessory for single patient use inserted, which is called barriette. The barriette prevents the passage of microorganisms into EasyOne Pro Respiratory Analysis System. A touch screen is integrated in the main unit that provides the user interface. The main power switch, different connections as well as different ports are located on the rear panel of the main unit. The EasyOne Pro can be used as a stand-alone system and can be connected to a network. The device has built-in quality control to assure correct test performance and equipment function.

The provided text describes the ndd EasyOne Pro Respiratory Analysis System, a device for lung function measurements, and details its substantial equivalence to predicate devices. It mentions testing performed but lacks specific quantifiable acceptance criteria and detailed study outcomes.

Here's an analysis based on the provided text sections {0-4}:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states conformance to standards and recommendations rather than specific numerical acceptance criteria.

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

The document states "Dynamic wave form testing was performed regarding the diagnostic spirometry tests" and "The DLCO performance was tested by using a DLCO simulator. In addition comparative measurements with another DLCO testing device". However, the specific sample sizes for these tests (e.g., number of waveforms or DLCO measurements) are not provided. The data provenance is not explicitly mentioned, but the nature of the tests (simulator and comparative measurements) suggests a controlled laboratory or clinical setting rather than solely retrospective data from human patients. The company is based in Zurich, Switzerland, so the testing might have occurred there or at a testing facility.

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

The document does not specify the number of experts used for ground truth or their qualifications. The ground truth for spirometry and DLCO is based on simulator outputs and comparison with a predicate device, as well as adherence to ATS recommendations, which are established by expert consensus in respiratory medicine.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method involving multiple human readers for the test set. The validation appears to be based on direct measurement comparisons against simulators and a predicate device as per established standards (ATS recommendations).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed according to this document. The device is for lung function measurement, not for interpreting medical images or data that typically require human readers with and without AI assistance in an MRMC study. The comparison is between the device's measurements and established standards/predicate devices, not between human readers.

6. If a Standalone Performance Study Was Done:

Yes, a standalone performance study was done. The document states:

• "Dynamic wave form testing was performed regarding the diagnostic spirometry tests."
• "The DLCO performance was tested by using a DLCO simulator."
• "comparative measurements with another DLCO testing device demonstrate that the EasyOne Pro Respiratory Analysis System meets the ATS recommendations for accuracy and precision for DLCO testing and the intended diagnostic spirometry tests."

These describe the testing of the EasyOne Pro's performance on its own, relative to reference methods (simulators, predicate devices) and standards (ATS recommendations), without direct human-in-the-loop interaction to evaluate its output.

7. The Type of Ground Truth Used:

The ground truth used for testing appears to be:

• Established standards/guidelines: Specifically, ATS (American Thoracic Society) recommendations for lung function measurements.
• Simulator outputs: For DLCO, "a DLCO simulator" was used.
• Predicate device measurements: For DLCO, "comparative measurements with another DLCO testing device" were performed, implying the predicate device served as a reference standard.

8. The Sample Size for the Training Set:

The document does not provide any information regarding a "training set" or its sample size. This type of device (a measurement instrument rather than an AI/machine learning diagnostic tool) would typically be validated through engineering and performance testing against physical standards and known reference devices, rather than through a machine learning training/test set paradigm.

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

As no training set is mentioned (see point 8), this information is not applicable and not provided in the document.

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