(56 days)
The Spirometry Option for Innocor is intended to be used as a diagnostic spirometer, used in pulmonary function testing, to measure the flow of gas moving into and out of a patient's lungs.
In order to produce data regarding the maximum performance with respect to tidal volume and ventilation, the specific parameters measured by the Innocor Spirometry Option are:
FEV1: Forced expiratory volume in one second
FVC: Forced vital capacity
FEV1%: FEV1/FVC
PEF: Peak expiratory flow
MEF 75*: Maximum instantaneous forced expiratory flow where 75% of the FVC remains to be expired
MEF 50*: Maximum instantaneous forced expiratory flow where 50% of the FVC remains to be expired
MEF 25*: Maximum instantaneous forced expiratory flow where 25% of the FVC remains to be expired
FET: Forced expiratory time
MVV: Maximum voluntary ventilation
- MEF 75 is equal to FEF 25 (maximal instantaneous forced expiratory flow where 25% of the FVC has been expired); MEF 50 is equal to FEF 50; MEF 25 is equal to FEF 75.
Innocor is a compact point-of-care device intended to be used for non-invasive measurement of a) cardiac output (CO) and other hemodynamic parameters utilizing inert gas rebreathing (IGR) technology, and b) metabolic parameters including oxygen uptake by means of a breath-by-breath gas exchange method. The Cardiopulmonary Exercise Testing Option to Innocor provides measurements of gas exchange parameters including oxygen uptake (VO2), carbon dioxide excretion (VCO2), ventilation (Vr) and end-tidal gas concentrations plus a number of derived parameters. These parameters are determined by simultaneous measurements of the respiratory flow and gas concentrations when breathing ambient air. The respiratory flow is measured by means of a differential pressure type flowmeter (pneumotachometer) placed between the respiratory valve unit and the patient. The gas exchange calculations are carried out online for each breath between the rebreathing tests, providing the opportunity to perform an incremental exercise test on a bicycle ergometer or treadmill and measure the progress of cardiac function, pulmonary function and gas exchange at the same time.
Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. Spirometry is recognized as a valuable screening test of general respiratory health.
The Spirometry Option for Innocor measures the subset of spirometric variables of a patient during a forced expiration testing procedure. These measured variables include FEV1 (forced expiratory volume in 1 second), FVC (forced vital capacity), FEV . PEF (peak expiratory flow), MEF 75 (Maximal instantaneous forced expiratory flow where 75% of the FVC remains to be expired), MEF 50, MEF 25, FET (Forced expiratory time) and MVV (Maximum voluntary ventilation). These parameters are determined by measurements of the respiratory flow when breathing ambient air during a spirometry test of a patient (tidal breathing followed by a full inspiration and then finally a maximal forced expiration). The respiratory flow is measured by means of a pneumotachometer.
The Spirometry Option for Innocor device was evaluated against the "Standardisation of Spirometry" document in the series "ATS/ERS Task Force: Standardisation of Lung Function Testing," issued by The American Thoracic Society (ATS) and the European Respiratory Society (ERS). The performance data demonstrates that its hardware and software meet the ATS/ERS standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Abbreviation | Name | Unit | Acceptance Criteria (ATS/ERS Standards) | Reported Device Performance |
|---|---|---|---|---|
| FEV1 | Forced expiratory volume in one second | L [BTPS] | Meets ATS/ERS standards | Meets ATS/ERS standards |
| FVC | Forced vital capacity | L [BTPS] | Meets ATS/ERS standards | Meets ATS/ERS standards |
| FEV1% | FEV1/FVC | % | Meets ATS/ERS standards | Meets ATS/ERS standards |
| PEF | Peak expiratory flow | L/sec [BTPS] | Meets ATS/ERS standards | Meets ATS/ERS standards |
| MEF 75* | Maximum instantaneous forced expiratory flow where 75% of the FVC remains to be expired | L/sec [BTPS] | Meets ATS/ERS standards | Meets ATS/ERS standards |
| MEF 50* | Maximum instantaneous forced expiratory flow where 50% of the FVC remains to be expired | L/sec [BTPS] | Meets ATS/ERS standards | Meets ATS/ERS standards |
| MEF 25* | Maximum instantaneous forced expiratory flow where 25% of the FVC remains to be expired | L/sec [BTPS] | Meets ATS/ERS standards | Meets ATS/ERS standards |
| FET | Forced expiratory time | Sec | Meets ATS/ERS standards | Meets ATS/ERS standards |
| MVV | Maximum voluntary ventilation | L/min [BTPS] | Meets ATS/ERS standards | Meets ATS/ERS standards |
*Note: MEF 75 is equal to FEF 25; MEF 50 is equal to FEF 50; MEF 25 is equal to FEF 75.
2. Sample size used for the test set and the data provenance:
- The document does not specify the sample size for the test set or the data provenance (country of origin, retrospective or prospective nature). It generally states that "Performance data demonstrates that the hardware and software meet the ATS/ERS standards."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document.
4. Adjudication method for the test set:
- This information is not provided in the document.
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:
- The document does not mention an MRMC comparative effectiveness study. This device is a diagnostic spirometer for measuring pulmonary function, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The study described is a standalone performance evaluation of the Spirometry Option for Innocor against established spirometry standards (ATS/ERS), without involving human-in-the-loop performance testing.
7. The type of ground truth used:
- The ground truth used is the ATS/ERS Standards for spirometry. These standards define the accepted physiological measurements for various spirometric parameters.
8. The sample size for the training set:
- The document does not specify a training set sample size, as the evaluation focuses on comparing the device's measurements to established standards rather than a machine learning model's training.
9. How the ground truth for the training set was established:
- The concept of a "training set" and associated ground truth establishment is not applicable in the context described. The device's performance is validated against pre-existing, widely accepted ATS/ERS Standards, which serve as the reference for accuracy and reliability in spirometry. These standards are established by expert medical societies (American Thoracic Society and European Respiratory Society) based on scientific consensus and extensive research in pulmonary function testing.
§ 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).