(65 days)
The Spirobank G spirometer is intended to be used by a physician or by a patient under the instruction of a physician or paramedic. The device is intended to test lung function and can make spirometry testing in people of all ages, excluding infants and neonates. It can be used in any setting.
Spirobank G is a spirometer designed to facilitate the total valuation of lung function. It is designed for use by specialist who require a simple, portable and compact device, yet at the same time being capable of calculating more than 30 spirometric parameters. Its connectivity capability (USB, Bluetooth) makes it suitable also for telemedicine applications.
The Spirobank G is a spirometer intended for lung function testing. The provided document focuses on demonstrating substantial equivalence to predicate devices (Spirobank and Spirobank II) rather than presenting a standalone study with detailed acceptance criteria and performance metrics for a novel AI-powered device.
However, based on the information provided, we can infer the acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety & Environmental Compliance (EN 60601-1:1990) | In compliance with the guideline and standards referenced. |
| Electromagnetic Compatibility (EN 60601-1-2:1993) | In compliance with the guideline and standards referenced. |
| Electrical Safety | Performs within its specifications. |
| Mechanical Durability | Performs within its specifications. |
| Safety (Operator and Patient) | Performs within its specifications. |
| Temperature/Humidity Performance | Performs within its specifications. |
| Spirometry Accuracy (ATS Standards) | Results obtained were within the range of accuracy required by ATS. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the spirometry accuracy testing or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Spirometry testing was performed according with American Thoracic Society (ATS) Standards."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For spirometry, the "ground truth" typically refers to precise measurements from a highly calibrated reference spirometer or simulated lung. Expert review would typically be for interpretation of results rather than establishing the raw spirometry ground truth.
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
No, an MRMC comparative effectiveness study was not done. The device is a spirometer, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the testing described is effectively a standalone performance evaluation of the device itself (hardware and embedded software) against established standards. The spirometer performs its measurements and calculations without continuous human intervention during the measurement process.
7. The Type of Ground Truth Used
For spirometry accuracy: The implied ground truth is the "range of accuracy required by ATS" standards, which would be based on comparison to highly accurate reference spirometry measurements or simulated lung volumes/flow profiles.
For safety and environmental criteria: Ground truth is compliance with the specific technical standards (e.g., EN 60601-1:1990, EN 60601-1-2:1993).
8. The Sample Size for the Training Set
This information is not applicable and not provided. The Spirobank G is a medical device that measures physiological parameters based on established physical principles, not a machine learning model that requires a "training set" in the conventional sense. Its "training" would involve calibration and engineering design based on physical and physiological principles.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the reasons stated above.
§ 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).