(258 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 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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Spirometry | Meets ATS recommendations for accuracy and precision during dynamic wave form testing. |
| DLCO (Diffusion Capacity) | Meets ATS recommendations for accuracy and precision, demonstrated by comparative measurements with another DLCO device and DLCO simulator testing. |
| Electrical Safety | Conforms with IEC 60601-1 and IEC 60601-1-2 requirements. |
| Biocompatibility | Materials used meet requirements in accordance with ISO 10993. |
| Software | Software verification and validation revealed that the EasyOne Pro Respiratory Analysis System meets the specified 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.
§ 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).