(238 days)
The Microlab spirometer is intended, for prescription use rno Mioreleb ope the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician offices, laboratories and occupational health testing environments.
The Microlab spirometry systems consists of the Microlab spirometer, digital volume transducer, transducer housing, AC power adapter, power supply cord, disposable cardboard mouthpieces, carrying case, quick start guide and operators manual. Optional accessories include calibration syringe, nose clips, serial cable and a serial to parallel converter for use of an external compatible printer.
Here's an analysis of the provided text regarding the Microlab Spirometer, focusing on the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by) | Reported Device Performance |
|---|---|
| Accuracy and precision standards set by the American Thoracic Society (ATS) | "Performance testing was conducted to demonstrate compliance with the accuracy and precision standards set by the American Thoracic Society." |
| Electrical safety requirements per IEC60601-1-2 | "The device was tested to demonstrate conformance with IEC60601-1-2 requirements for electrical safety." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance testing related to ATS standards. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature) for this testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The testing appears to be against established technical standards (ATS and IEC), rather than requiring expert-adjudicated ground truth derived from patient data.
4. Adjudication Method for the Test Set
This information is not applicable/provided as the testing was against pre-defined technical standards rather than requiring human adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned in the provided document. The submission focuses on demonstrating technical compliance and substantial equivalence to a predicate device.
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 of the device against a set of predetermined technical standards (ATS for accuracy/precision and IEC for electrical safety). There is no indication of human-in-the-loop performance testing being conducted or required for this type of device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is the technical accuracy and precision standards set by the American Thoracic Society (ATS) and the electrical safety requirements of IEC60601-1-2. These are objective, pre-defined standards rather than patient-specific or expert-derived ground truth.
8. The Sample Size for the Training Set
This information is not applicable/provided. Spirometers are hardware devices that measure physiological parameters. They do not typically involve training sets in the machine learning sense. The "training" would be inherent in the device's design and calibration against established physical standards.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided for the reasons stated above. The device's "training" and calibration would be against physical standards and known physiological principles, not through a training dataset of medical images or patient outcomes.
§ 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).