(194 days)
Medikro® Spirometer is a device that measures lung air volume and airflow rate for pulmonary disease diagnosis and screening. These measurements provide information about a patient's pulmonary function which may be compared with normal values or the patient's previous values.
The device is designed to test pulmonary function and obtain spirometric indices for
- adult and pediatric patients 12 years and older,
- hospital and clinic use only.
Medikro® spirometer runs on a personal computer with Microsoft Windows operating systems.
Medikro@ spirometer unit is connected to PC via USB port (USB model). SpiroSafe disposable flow transducer is connected to the spirometer unit via pressure tube. Nose clip is used to prevent air flow from nose during measurements. Optional calibration syringe is used for recommended daily volume calibrations.
Medikro® spirometers are used to measure lung air volume and airflow rate. Medikro® Spirometry Software is used to perform the measurement and calculate the measurement volume based on chosen reference value. The reference value is based on patient's gender, race and age. User can analyze the results in different presentations and create a final report based on the results and patient information.
The spirometers take all the power that it needs from the USB port, so no other external or internal power supply is needed.
The Medikro® Spirometer (M913 Medikro® Nano, M914 Medikro® Primo, M915 Medikro® Pro) is designed to measure lung air volume and airflow rate for pulmonary disease diagnosis and screening. The devices were tested to ensure they meet the essential performance criteria for spirometers as defined by the American Thoracic Society (ATS) and ISO 26782 standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ATS/ERS & ISO 26782 Standards) | Reported Device Performance (Medikro® Spirometers) |
|---|---|
| ATS/ERS Standards (Eur Respir J, 2005, Vol 26, pp. 948-968): | All units meet the recommendations for: |
| Measuring FVC | Met |
| Measuring FEV1 | Met |
| Measuring FEF25-75% | Met |
| Measuring PEF | Met |
| Measuring MVV | Met |
| Resistance to flow | Met |
| ISO 26782:2009 Standards: | All units meet the ISO 26782 requirements for: |
| Measuring FVC accuracy and repeatability | Met |
| Measuring FEV1 accuracy and repeatability | Met |
| Measuring FEV6 accuracy and repeatability | Met |
| Linearity | Met |
| Impedance | Met |
| Safety and EMC Standards: | |
| AAMI / ANSI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) | Complied |
| IEC 60601-1-2 Edition 3:2007-03, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | Complied |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size in terms of number of human subjects or unique cases for the performance testing. Instead, the testing involved exposing all three device models (M913 Medikro® Nano, M914 Medikro® Primo, and M915 Medikro® Pro) to standardized conditions using "24 standard waveforms" as specified by the American Thoracic Society (ATS) and further tests as per ISO 26782.
The data provenance is not explicitly stated as "country of origin" for the ATS/ERS and ISO 26782 standard waveforms. These are international standards, implying a general applicability rather than specific regional data. The testing itself was performed at CSA Group CB testing laboratory and Savonia Polytechnic EMC laboratory, both located in Finland, which is the manufacturer's country of origin. The study appears to be prospective in nature, as it involved physical testing of the manufactured devices against predefined international standards.
3. Number, Qualifications, and Adjudication Method of Experts
This study did not involve human experts to establish ground truth for clinical performance in the traditional sense (e.g., radiologists interpreting images). Instead, the "ground truth" or reference for the device's performance was established by adherence to universally accepted engineering and medical device standards for spirometry.
- Experts: Not applicable for establishing ground truth of the test set in this context. The "experts" in this scenario would be the bodies that define the ATS/ERS and ISO standards, which are internationally recognized professional organizations in respiratory medicine and standardization.
- Qualifications: Not applicable.
- Adjudication method: Not applicable.
4. Adjudication Method (for the test set)
Not applicable. The performance was assessed against objective, predefined values and ranges specified by the ATS/ERS and ISO 26782 standards. There was no expert adjudication process in this technical validation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is a diagnostic spirometer, not an AI-assisted diagnostic tool for interpretation of human expert readings. The study focuses on the technical performance of the device in accurately measuring lung parameters, not on how human readers' interpretations improve with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The performance of the Medikro® spirometers was evaluated in isolation (algorithm only, as they calculate measurements based on raw data) against established international standards (ATS/ERS and ISO 26782) without human intervention in the measurement process. The device's ability to accurately measure FVC, FEV1, FEF25-75%, PEF, MVV, and FEV6, as well as its linearity and impedance characteristics, were tested directly against these benchmarks.
7. Type of Ground Truth Used
The ground truth used was based on internationally recognized performance standards and simulated waveforms. Specifically:
- Standardized Waveforms: The "24 standard waveforms" from the American Thoracic Society (ATS) served as the reference for dynamic performance.
- Engineering Specifications: The ISO 26782 standard provides precise numerical acceptance criteria for accuracy, repeatability, linearity, and impedance.
- Safety and EMC Standards: AAMI / ANSI ES 60601-1 and IEC 60601-1-2 define the ground truth for electrical safety and electromagnetic compatibility.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI algorithms. The device performs calculations based on established physiological formulas and measurement principles, not through a learned model from a training dataset. Therefore, this question is not applicable to the described device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for machine learning. The device's operation relies on known physics and physiological models, not on a data-trained algorithm.
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).