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The EasyOne Sky spirometer is intended to conduct diagnostic spirometry testing on adults and pediatric patients starting at age 4. The EasyOne Sky spirometer is used by general practitioners, specialists and healthcare professionals. The EasyOne Sky is used in hospitals, clinical settings, and in occupational medicine.

The product EasyOne Sky (EOS) is a medical electrical equipment for spirometry testing. It consists of the hand-held TrueFlow Sensor FT (SeNe) comprising an ultrasonic flow sensor that conducts air flow measurements, the application EasyOne Mobile (EOMA), and the breathing mouthpiece EasyOne FlowTube (EOFT). The EOS can be used with the optional accessories EasyOne Filter FT and a nose clip.

Key functions:

• . The key function of the TrueFlow Sensor FT (SeNe) is to acquire patient flow data by measuring transit-times of ultrasonic pulses and to send data wireless (via Bluetooth Low Energy) to the host system. The measurements and data transmission are performed by the firmware of the SeNe defined as MDSW with clinical functions.
• . The key function of the application EasyOne Mobile (EOMA) is to trigger the start of the measurement with the TrueFlow Sensor FT, to communicate with it and to visualize the data received from it.
• . The EasyOne FlowTube (EOFT) is an individually packaged, single-patient-use breathing tube and is intended to canalize patient breath through the flow sensor tube. The EOFT is an essential accessory to EOS.

The EasyOne Sky spirometer, as described in the provided 510(k) summary, underwent various non-clinical tests to demonstrate its substantial equivalence to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document specifies performance testing in accordance with ISO 26782:2009 for 13 waveforms. This refers to a standardized set of flow-volume and volume-time waveforms designed to test spirometer performance across a range of physiological conditions. The provenance of these waveforms is standardized and not patient-specific. The document does not specify additional clinical test set sizes or their provenance (e.g., country of origin, retrospective/prospective). The assessment relies heavily on compliance with recognized performance standards rather than a separate clinical test set of patient data.

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

The ground truth for the performance testing is established by international spirometry standards (ATS/ERS/ISO), which define the expected values for the 13 waveforms used in testing. These standards are developed by expert committees, but the document does not mention individual experts specifically establishing ground truth for this particular device's test set, as it relies on compliance with pre-defined standard waveforms.

4. Adjudication method for the test set

No specific adjudication method (like 2+1, 3+1) is mentioned for a test set. The evaluation is based on the device's technical performance against established international standards for spirometry.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or reported in this 510(k) summary. The device is a diagnostic spirometer, not an AI-assisted diagnostic tool that interprets images or signals requiring human reader input for comparison.

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

Yes, a standalone performance assessment was effectively done. The spirometer's core function is to measure and calculate spirometry parameters based on patient breathing. The "Performance" section explicitly states compliance with established spirometry standards (ATS/ERS/ISO), which are machine-based performance tests using standardized waveforms. The device's firmware performs the measurements and calculates parameters independently, and this is what was tested against international accuracy standards.

7. The type of ground truth used

The ground truth used for performance testing (accuracy, repeatability, linearity) is based on established spirometry standards and guidelines (ATS/ERS/ISO). Specifically, ISO 26782:2009 includes defined "reference waveforms" for evaluating spirometers, which serve as the ground truth against which the device's measurements are compared.

8. The sample size for the training set

The document does not provide information about a "training set" in the context of machine learning. The device is a traditional medical device that performs measurements and calculations based on physics (ultrasonic transit-time measurement) and programmed algorithms derived from clinical standards, not an AI/ML-based device that requires a training set of data.

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

As there is no mention of a machine learning "training set," the concept of establishing ground truth for it is not applicable here.

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The EasyOne Filter is intended to be used in combination with NDD breathing mouthpieces to reduce bacteria, viruses and other particulates from the patient's exhaled air while performing flow measurements, such as spirometry tests. The EasyOne Filter is a single-use device and intended for single-patient use only.

The EasyOne Filter is a viral, bacterial filter designed to be used with NDD breathing mouthpieces during flow measurements, e.g. for spirometry testing with NDD spirometers. The EasyOne Filter exists in two variants which differ in the connection interface to enable mounting on the EasyOne FlowTube. The EasyOne Filter is composed of two injection molded polymeric parts which enclose a filter medium. The EasyOne Filter is an optional accessory and reduces viruses, bacteria, and other particles that may be released by the patient and thus contaminate the test environment. The EasyOne Filter is non-sterile and for single use.

The provided text is a 510(k) summary for the EasyOne Filter, a breathing circuit bacterial filter. It details the device's characteristics, comparison to predicate devices, and the results of non-clinical, and usability tests. However, it does not describe a study involving an AI/algorithm or human readers for diagnostic purposes (e.g., radiologists interpreting images). The device itself is a physical filter for spirometry, not a diagnostic AI tool.

Therefore, many of the requested points, such as MRMC studies, standalone algorithm performance, number of experts for ground truth, and training set details, are not applicable to this type of medical device submission.

Here's an attempt to answer the applicable points based on the provided text, and explicitly state when information is not present or not relevant to this specific device:

1. A table of acceptance criteria and the reported device performance

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

• Filtration Efficiency: Not explicitly stated, but implies lab testing.
• Human Test (System test): The document mentions "Human subjects performed a FVL test session". The number of subjects is not specified.
• Data Provenance: Not specified, but given the manufacturer is based in Switzerland, it's likely to be European or internationally sourced lab/human data. The tests are general performance tests for a physical device, not tied to specific patient populations or retrospective/prospective clinical data in the way an AI diagnostic would be.

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

• Not applicable. This device is a physical filter, not a diagnostic tool requiring expert interpretation or ground truth establishment in the context of diagnostic accuracy. The tests are based on established engineering and medical device standards (e.g., ISO, ATS/ERS).

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

• Not applicable.

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-assisted diagnostic device. Its function is to filter exhaled air. The "human test" was to confirm the device doesn't negatively impact spirometry measurements, not to assess human diagnostic performance with/without AI.

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

• Not applicable. This is a physical filter, not an algorithm.

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

• The "ground truth" for this device exists in the form of established engineering and medical standards (e.g., ISO 10993 for biocompatibility, ISO 18562 for gas path emissions, ATS/ERS standards for spirometry). The performance of the filter is measured against specified physical and biological parameters. Not ground truth from medical diagnoses.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI model requiring a training set.

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

• Not applicable.

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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 EasyOne Air spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients over 4 years old. The EasyOne Air spirometer is used by general practitioners, specialists, and health care professionals, in hospitals and clinical settings in occupational medicine.

The ndd EasyOne Air is a diagnostic spirometer.

In order to conduct simple diagnostic spirometry testing, the EasyOne Air is used in combination with a commercially available disposable breathing tube with integrated mouthpiece (EasyOne Flow Tube).

The sensor is an ultrasound flow sensor that measures pulse transit-time to determine gas flow velocity and volume, as well as molar mass of the gas. The collected data is used for pulmonary function evaluation and data management. The results of the testing are stored in a database and reports can be displayed or printed.

This document describes the EasyOne Air Spirometer. However, it does not contain the specific information required to complete all parts of your request, especially regarding a clinical study with acceptance criteria and reported device performance in the format you provided. The document primarily focuses on demonstrating substantial equivalence to a predicate device for FDA 510(k) clearance.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document mentions "Dynamic wave form testing and comparative testing with a commercially available ndd Spirometer confirmed that the EasyOne Air Spirometer meets the spirometry recommendations for accuracy and precision published by the American Thoracic Society (ATS)."

However, it does not provide a table of specific acceptance criteria (e.g., specific thresholds for FVC accuracy) or the numerical reported device performance in a format that could be directly extracted into such a table. It only states that the device "meets the spirometry recommendations."

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

This information is not provided in the document. The testing described is "Dynamic wave form testing and comparative testing," which implies laboratory testing and comparison against a predicate device, rather than a clinical study with human subjects whose data provenance would be relevant.

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 applicable and therefore not provided in the document. The testing was against established spirometry recommendations and comparison to a predicate device, not against ground truth established by experts interpreting outputs from the device in a clinical context.

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

This information is not applicable and therefore not provided. No adjudication method is described because there's no expert interpretation of device outputs.

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 applicable and therefore not provided. The EasyOne Air Spirometer is a diagnostic device for measuring lung function, not an AI-powered image analysis tool that would typically involve human readers and efficacy studies like MRMC.

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

The document describes the performance of the "EasyOne Air Spirometer" itself, which is a standalone device in the context of spirometry. It measures and processes data without human input affecting the measurement itself. The results are then displayed for interpretation by healthcare professionals. So, in a sense, its primary function is "standalone" (algorithm only) in generating the spirometry measurements. However, the term "standalone performance" often refers to an AI algorithm's performance before human review in a diagnostic workflow, which isn't directly analogous here.

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

The "ground truth" for the performance claims appears to be:

• ATS (American Thoracic Society) spirometry recommendations for accuracy and precision.
• Comparison to the predicate device (ndd EasyOne Spirometer).

8. The sample size for the training set

This information is not applicable and therefore not provided. The EasyOne Air Spirometer is a measurement device, not an AI/ML model that requires a "training set" in the conventional sense.

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

This information is not applicable for the same reason as point 8.

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