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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 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 ndd EasyOne Pro Respiratory Analysis System is a portable device for performing lung function measurements. 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 and FRC tests a valve unit must additionally be connected to the handheld 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 and its substantial equivalence to predicate devices, but it does not provide a detailed table of specific acceptance criteria and reported device performance with numerical values or statistical metrics.

However, I can extract the information that is present and highlight what is missing based on your request.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that the device meets ATS recommendations and other specified criteria, but it does not provide the specific numerical thresholds for these criteria (e.g., a specific percentage accuracy, range of precision) or the actual measured performance data from the tests (e.g., measured accuracy values, standard deviations).

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

• Sample Size (Test Set):
  • For Spirometry and DLCO: Not explicitly stated. The document mentions "comparative measurements with another DLCO testing device" but doesn't specify the number of measurements or subjects.
  • For FRC: "multiple breath washout tests in patients and healthy subjects were performed." The exact number of patients and healthy subjects is not specified.
• Data Provenance: Not explicitly stated. The document does not mention the country of origin of the data.
• Retrospective or Prospective: Not explicitly stated. Given the nature of performance testing for a new device, it is likely prospective testing on simulators and possibly a cohort of subjects, but this is not explicitly confirmed.

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 testing described focuses on device performance against simulators and established standards (like ATS recommendations), rather than expert-established ground truth for diagnostic accuracy in a clinical context.

4. Adjudication Method for the Test Set

• This information is not provided in the document. As the tests primarily involved comparisons to simulators and existing devices/standards, a human expert adjudication method as typically used for AI-driven diagnostic tools is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• This information is not provided in the document. The ndd EasyOne Pro Respiratory Analysis System is a pulmonary function testing device, not an AI-assisted diagnostic tool designed to be used by human "readers" (like radiologists). Therefore, an MRMC study or an assessment of human improvement with AI assistance is not applicable to this device as described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• The performance testing described (dynamic waveform testing, DLCO simulator, FRC simulator tests) are essentially "standalone" device performance evaluations in a controlled environment, demonstrating the device's ability to accurately measure lung function parameters. The device itself is a measurement tool, not an "algorithm only" in the sense of an interpretive AI system. Its accuracy is evaluated inherently in a standalone manner against known inputs or reference methods.

7. The Type of Ground Truth Used

• Spirometry, DLCO, FRC: The ground truth for these tests appears to be based on:
  • Simulators: Dynamic waveform testing for spirometry, a DLCO simulator, and an FRC simulator. These simulators provide known, controlled inputs against which the device's measurements are compared.
  • ATS Recommendations: The device's performance is gauged against the established accuracy and precision standards set by the American Thoracic Society (ATS) for lung function measurements.
  • Comparative Measurements: Comparisons were made with "another DLCO testing device," implying the established accuracy of that device served as a reference.
  • Healthy Subjects/Patients: For FRC, tests were also performed in these groups, presumably to assess real-world performance against expected physiological ranges or established clinical standards.

8. The Sample Size for the Training Set

• This information is not provided and is likely not applicable in the context of this device. The ndd EasyOne Pro is a measurement device based on known physiological principles and sensor technology, not a machine learning or AI model that requires a "training set" in the traditional sense. Its software verification and validation would refer to standard software engineering practices, not AI model training.

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

• This information is not provided and is not applicable for the same reasons mentioned in point 8.

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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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The ndd Medical Technologies Easy on-PC Spirometer is intended for prescriptions use only to conduct diagnostic spirometry testing of adults and pediatric patients over 4 years old, in general practice and specialty physician, industrial and hospital settings.

Easy on-PC is a PC based diagnostic spirometer and consists of a PC software and the Easy on-PC sensor (Spiroson-AS). The Easy on-PC software is installed on a Windows based PC or laptop computer to which the Easy on-PC sensor is connected.

In order to conduct simple diagnostic spirometry testing, the Easy on-PC sensor is used in combination with a commercially available disposable breathing tube with integrated mouthpiece (spirette).

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

Here's an analysis of the acceptance criteria and study detailed in the provided document:

The document focuses on the Easy on-PC Spirometer, and the primary performance evaluation mentioned is against standards for diagnostic spirometry.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document mentions "Dynamic wave form testing" to confirm ATS recommendations. This typically involves using a calibrated syringe or similar device that generates known flow-volume curves. The document does not specify the sample size (e.g., number of waveforms, number of tests, specific range of volumes/flows tested) or the data provenance in terms of patient data (e.g., country of origin, retrospective/prospective). The testing described is a technical performance validation rather than a clinical study with patient data.

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

This information is not provided in the document. For technical performance testing against ATS standards, the "ground truth" would be established by the precise and calibrated nature of the waveform generation equipment, not by clinical experts making diagnoses.

4. Adjudication Method for the Test Set

This information is not mentioned in the document, as the testing described is primarily technical performance validation against a standard, not a subjective clinical assessment requiring adjudication.

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 MRMC comparative effectiveness study was not performed, nor is it applicable to this device. This device is a diagnostic spirometer, which directly measures physiological parameters (flow, volume). It does not involve human "readers" interpreting output in the way an AI-assisted diagnostic imaging system would. The "assistance" it provides is the measurement itself and presentation of results, not interpretive aid to a human reader in the context of an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The primary performance evaluation described is "standalone" in the sense that the device itself (the sensor and software) takes measurements and processes them to produce results in accordance with ATS standards. There's no mention of a human-in-the-loop performance evaluation in the context of improving diagnostic accuracy; rather, the device is the diagnostic tool.

7. The Type of Ground Truth Used

The ground truth used for the primary performance claim (meeting ATS recommendations) was established by standardized, simulated waveforms generated by "dynamic wave form testing." This is a form of technical or engineering ground truth based on established physical and physiological standards for spirometry. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not describe any "training set" as this device is a measurement instrument based on physical principles (ultrasound transit-time) and does not rely on machine learning or AI models that require data training.

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

As there is no mention of a training set, the establishment of ground truth for such a set is not applicable to this device.

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