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510(k) Data Aggregation
(264 days)
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.
| Parameter/Test | Acceptance Criteria (ATS Recommendations) | Reported Device Performance |
|---|---|---|
| Spirometry | ATS recommendations for accuracy and precision (specific numerical values not provided in this document, but typically involve thresholds for flow and volume measurements, e.g., ±3% or 50mL for FEV1/FVC, etc.) | "The EasyOne Pro Respiratory Analysis System devices meet the ATS recommendations for accuracy and precision for Spirometry..." |
| "Simulated Spirometry, DLCO and MBW testing, as well as testing with humans, confirmed that the modified EasyOne Pro Respiratory Analysis System devices meet the recommendations for accuracy and precision for Spirometry..." | ||
| DLCO (Single Breath CO Diffusion) | ATS recommendations for accuracy and precision (specific numerical values not provided in this document) | "...and Single Breath CO Diffusion (DLCO) tests... The EasyOne Pro Respiratory Analysis System devices meet the ATS recommendations for accuracy and precision for... DLCO..." |
| "Simulated Spirometry, DLCO and MBW testing, as well as testing with humans, confirmed that the modified EasyOne Pro Respiratory Analysis System devices meet the recommendations for accuracy and precision for... DLCO..." | ||
| MBW (Nitrogen Multiple Breath Washout) | ATS recommendations for accuracy and precision (specific numerical values not provided in this document) | "...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... MBW tests." |
| "Simulated Spirometry, DLCO and MBW testing, as well as testing with humans, confirmed that the modified EasyOne Pro Respiratory Analysis System devices meet the recommendations for accuracy and precision for... MBW tests." | ||
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests) | "The modified devices were tested to demonstrate conformance with the requirements for medical electrical equipment basic safety and essential performance of standards IEC 60601-1 and IEC 60601-1-2." |
| Basic Safety & Essential Performance | IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | "The modified devices were tested to demonstrate conformance with the requirements for medical electrical equipment basic safety and essential performance of standards IEC 60601-1 and IEC 60601-1-2." |
| Software Verification & Validation | IEC 62304 (Medical device software - Software life cycle processes) | "Software verification and validation in accordance with IEC 62304 confirmed that the modified EasyOne Pro Respiratory Analysis System meets the specified criteria." |
| Biocompatibility | ISO 10993-1: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process | "Biocompatibility was evaluated in accordance with ISO 10993-1: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process." |
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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