(161 days)
The MIR Minispir spirometer and Spirolab III spirometer and pulse oximeter are intended to be used by either a physician, respiratory therapist or technician. The devices are intended to test lung function and can make:
- spirometry testing in people of all ages, excluding infants and neonates .
- oximetry testing in people of all ages. .
They can be used in any setting.
MIR Minispir - Spirolab III are instruments for the analysis of respiratory function, which carries out three different spirometric tests, FVC, VC(insp/exp) and MVV, with a calculation of the main spirometric parameters, predicted values and percentage deviations compared to the measured values. Plus Flow/Volume and Volume/time curves and the interpretation of the FVC test following the international spirometry standards (ATS/ERS). What is more Spirolab III with its integrated oximetry option, can calculate both Oxygen Saturation (expressed as %SpO2) and Pulse Rate (expressed as Beats Per Minutes- BPM). In additon Spirolab III calculates several (up to 20) additional statistical parameters derived from the SpO2 and the pulse rate.
Acceptance Criteria and Study for MIR Minispir - Spirolab III
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Spirometry Function | Within accuracy range required by American Thoracic Society (ATS) Standards | Results obtained were within the range of accuracy required by ATS. |
| Safety & Environmental (EN 60601-1:1990; EN 60601-1-2:1993) | Compliance with guidelines and standards | In compliance with the guidelines and standards referenced. |
| Electromagnetic Compatibility (EMC) | Within specifications | Performs within its specifications. |
| Electrical, Mechanical Durability | Within specifications | Performs within its specifications. |
| Safety (Operator and Patient) | Within specifications | Performs within its specifications. |
| Temperature/Humidity Testing | Within specifications | Performs within its specifications. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size for the "test set" used for spirometry or oximetry performance evaluation. It generally states that "testing was done."
The data provenance is not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The document refers to compliance with "American Thoracic Society (ATS) Standards" for spirometry, implying a recognized standard as the benchmark rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study is not mentioned. The study focuses on demonstrating that the device meets established technical standards (ATS) and safety regulations, rather than comparing its performance against humans or human performance with/without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the testing described appears to be a standalone performance evaluation. The device's spirometry function was tested "according with American Thoracic Society (ATS) Standards," which implies an assessment of the device's accuracy in measuring and calculating spirometric parameters. The safety and environmental testing also pertains to the standalone device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For spirometry, the ground truth was based on the American Thoracic Society (ATS) Standards. This implies an objective, standardized set of criteria and acceptable ranges for spirometric measurements and calculations.
For safety and environmental testing, the ground truth was compliance with EN 60601-1:1990 and EN 60601-1-2:1993 (safety and EMC standards) and the device's own specifications.
8. The Sample Size for the Training Set
The document does not mention a training set. This is not an AI/ML device in the modern sense that would typically involve a "training set" for model development. The algorithms for spirometry and oximetry calculation are stated to be the same as the predicate devices, suggesting pre-existing, validated algorithms rather than newly trained ones.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of this device, this question is not applicable. The device relies on established algorithms and compliance with regulatory standards.
§ 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).