(207 days)
The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The Vitalograph micro is a handheld spirometer designed for lung function for use on adults and pediatrics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healthcare provider.
Vitalograph Model 6300 micro is a handheld portable spirometer for performing Spirometry testing to aid in measuring the effect of lung disease on pulmonary function. The device may be used in hospital, healthcare facilities and homes under the supervision of a healthcare provider.
The intended use of the 6300 micro is in the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry.
The proposed device consists of a main body which incorporates an LCD, a touch panel, pressure transducer and flow circuitry as well as a detachable flow head. The device is used with a pulmonary function filter. Reports may be printed using the USB cable provided.
Principles of Operation: The Vitalograph micro measures a subject's lung ventilation by using a flowhead containing a Fleisch Pneumotachograph capable of giving linear signals throughout the entire physiological range. During testing, the airflow through the flowhead produces a pressure differential. Internally this pressure is applied to a pressure transducer, which produces an electric signal. This signal is converted into digital form so that the unit can perform calculations and display the results.
Primary functions are:
- Interaction will be via the touch screen interface.
- The model 6300 Compact performs spirometric measurements using the established fleisch Pneumotachograph, using single breath and multiple-breath testing techniques, to display and record lung volumes and flow rates (including FVC, FEV1, FEV6, PEF, MVV and VC) and their sub-divisions to aid in the measuring the effect of lung disease on pulmonary function
- Record subject demographic data.
- Produce printed reports to external printers.
The provided text describes the Vitalograph Model 6300 micro, a diagnostic spirometer, and its substantial equivalence to predicate devices, rather than a clinical study establishing AI performance. Therefore, many of the requested elements for AI/ML device studies, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable.
However, I can extract information related to the acceptance criteria (performance standards) and the study that proves the device meets these criteria in the context of this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Vitalograph Model 6300 micro are primarily based on international performance standards for spirometers. The reported device performance indicates successful compliance with these standards.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| Performance Standards: | |
| ISO 26782: Spirometers for measurement of time forced expired volumes in humans | Successfully passed |
| ATS/ERS 2005: Standardisation of Lung Function Testing | Successfully passed |
| ISO 23747: Peak expiratory flow meters for assessment of pulmonary function | Successfully passed |
| IEC/EN 60601 (EN 60601-1-1 and EN 60601-1-2) | Successfully passed |
| Mechanical/Environmental Standards: | |
| Drop test of packaged device from specified height | Satisfactory results |
| Storage conditions testing | Satisfactory results |
| Operating temperature limits testing | Satisfactory results |
| Cleaning method validation | Satisfactory results |
2. Sample Size Used for the Test Set and Data Provenance
This is a non-clinical, bench testing study. Therefore, there is no "sample size" in the context of patient data. The testing involves the device itself undergoing various physical and performance evaluations against established standards. The data provenance is from non-clinical testing conducted by the manufacturer, Vitalograph Ireland Ltd., in Ireland.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of non-clinical device testing. Ground truth is established by the international performance standards themselves, which are developed by expert consensus within their respective standardization bodies. The tests evaluate the device's adherence to these predefined criteria.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against specified performance limits outlined in the standards. There is no human adjudication in the sense of reviewing results to establish ground truth for individual cases.
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 not an AI/ML device, nor is it a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a standalone medical device (spirometer) designed for direct measurement, not an algorithm. Its performance is measured as a standalone instrument.
7. The type of ground truth used
The ground truth for this device's performance claims is defined by the international and national performance standards (e.g., ISO 26782, ATS/ERS 2005, ISO 23747, IEC/EN 60601). The device's measurements are compared against the specifications and tolerances outlined in these standards.
8. The sample size for the training set
Not applicable. There is no "training set" as this is a traditional medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable.
§ 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).