(210 days)
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
| Test/Parameter | Acceptance Criteria (Stated) | Reported Device Performance (Implied that criteria were met) |
|---|---|---|
| Spirometry Tests | Meet ATS recommendations for accuracy and precision | Successfully met ATS recommendations (via dynamic waveform testing, comparative measurements) |
| DLCO Testing | Meet ATS recommendations for accuracy and precision | Successfully met ATS recommendations (via DLCO simulator, comparative measurements) |
| FRC Testing (N2 Washout) | Not explicitly stated, but "acceptance criteria" for performance | Successfully met "acceptance criteria" (via FRC simulator, patient/healthy subject tests) |
| Electrical Safety | Conformance with IEC 60601-1 and IEC 60601-1-2 | Met IEC 60601-1 and IEC 60601-1-2 requirements |
| Biocompatibility | Conformance with ISO 10993 | Met ISO 10993 requirements |
| Software Verification/Validation | Meet specified criteria | Met specified criteria |
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.
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).