(1213 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 for
- . adult and pediatric patients,
- hospital and clinic use only.
Medikro® SpiroStar spirometer runs on a personal computer with Microsoft Windows operating systems.
Medikro® SpiroStar spirometer unit is connected to PC via USB port (USB model) or via serial port (DX model). SpiroSafe disposable flow transducer is connected to the spirometer unit via pressure tube. A nose clip is used to prevent air flow from nose during measurements. Optional calibration syringe is used for recommended daily volume calibrations.
Medikro® SpiroStar 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 or serial port, so no other external or internal power supply is needed.
The Medikro® SpiroStar device, including models M929 (USB) and M921 (DX), is a diagnostic spirometer intended to measure lung air volume and airflow rate for pulmonary disease diagnosis and screening. The device's performance was evaluated against the American Thoracic Society (ATS) recommendations for spirometers to demonstrate substantial equivalence to predicate devices.
1. A table of acceptance criteria and the reported device performance
| Performance Criteria (ATS Recommendations) | Acceptance Criteria for Spirometers (ATS) | Reported Device Performance (Medikro® SpiroStar USB & DX) |
|---|---|---|
| Measuring FVC | Meets ATS recommendations | Meets ATS recommendations |
| Measuring FEV1 | Meets ATS recommendations | Meets ATS recommendations |
| Measuring FEF25-75% | Meets ATS recommendations | Meets ATS recommendations |
| Measuring PEF | Meets ATS recommendations | Meets ATS recommendations |
| Resistance to flow | Meets ATS recommendations | Meets ATS recommendations |
| Testing under BTPS conditions | Meets ATS recommendations | Meets ATS recommendations |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the test set in terms of number of patients or spirometry maneuvers. Instead, it refers to "American Thoracic Society (ATS) 24 standard waveforms test". This suggests the use of a standardized set of simulated waveforms rather than patient data. The provenance of these standard waveforms is the American Thoracic Society. It is a retrospective evaluation against established synthetic data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The ground truth for this study was established by the "American Thoracic Society (ATS) 24 standard waveforms". These are not "expert-generated ground truth" in the typical sense of a clinical interpretation, but rather predefined, standardized synthetic waveforms with known, precise values for spirometry parameters. Therefore, no human experts were involved in establishing the "ground truth" for the test set in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The test involved comparing the device's measurements against the known values of the ATS 24 standard waveforms. This is a direct measurement comparison, not an expert-based adjudication process.
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
Not applicable. This is a performance study for a diagnostic spirometer, which directly measures physiological parameters. It is not an AI-based interpretation system, and therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was conducted. The Medikro® SpiroStar units (USB and DX) were tested directly against the ATS 24 standard waveforms to determine if their measurements met the specified recommendations. This is an algorithm-only (device-only) performance assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The type of ground truth used was standardized synthetic waveforms with known, precise values, specifically the American Thoracic Society (ATS) 24 standard waveforms.
8. The sample size for the training set
The document does not mention a training set. This type of device (diagnostic spirometer) typically relies on engineering and physiological principles for its design and calibration, rather than machine learning models that require training data. The testing described is a validation of the device's accuracy against established standards.
9. How the ground truth for the training set was established
Not applicable, as no training set or machine learning components are described in the context of this device's performance evaluation.
§ 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).