(165 days)
The Spirobank II spirometer and pulse oximeter 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 .
- oximetry testing in people of all ages. .
It can be used in any setting.
MIR Spirobank II is a spirometer and pulse oximeter, 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, and monitors the oxygen saturation and pulse rate. It also calculates several additional statistical parameters derived from the SpO2 and the pulse rate. Its connectivity capability (USB, Bluetooth, internal modem for acoustic coupling to telephone, RS232) makes it suitable also for telemedicine applications.
The MIR Spirobank II is a spirometer and pulse oximeter. It was deemed substantially equivalent to MIR Spirobank (K983909) and MIR Spirotel (K043528).
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Spirometry performance according to ATS Standards | Results obtained were within the range of accuracy required by ATS. |
| Oximetry performance within specification | Results obtained were within specification. |
Note: The specific numerical acceptance criteria for ATS standards and oximetry specifications are not detailed in the provided summary.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for the clinical testing of spirometry and oximetry functions. It only states that "Testing of device performance included clinical testing of both spirometry and pulse oximetry functions."
The data provenance (e.g., country of origin, retrospective or prospective) is not explicitly mentioned.
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 summary.
4. Adjudication method for the test set
This information is not provided in the summary.
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
An MRMC comparative effectiveness study is not mentioned. This device is a diagnostic tool (spirometer and oximeter) and does not involve AI assistance for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a standalone spirometer and pulse oximeter. The testing described (spirometry and oximetry) inherently evaluates the device's performance in a standalone capacity without direct human-in-the-loop AI assistance. The measurements are taken by the device, and the results are then interpreted by a physician or patient under physician instruction.
7. The type of ground truth used
- Spirometry: The ground truth for spirometry testing was based on compliance with American Thoracic Society (ATS) Standards. This implies that the device's output parameters were compared against accepted physiological ranges and accuracy requirements defined by the ATS.
- Oximetry: The ground truth for oximetry testing was established through a "desaturation trial." This typically involves inducing controlled desaturation and comparing the device's readings to known, accurate reference measurements (e.g., from a co-oximeter or arterial blood gas analysis), although the specific reference method is not detailed.
8. The sample size for the training set
This information is not provided in the summary. This device is a traditional medical device and not explicitly an AI/ML-based device that would typically involve a separate training set in the machine learning context. The "training" for such devices is usually the engineering design and calibration processes based on known physiological principles and standards.
9. How the ground truth for the training set was established
As noted in point 8, the concept of a "training set" as understood in AI/ML is not directly applicable here. The device's algorithms and performance are established through adherence to recognized medical standards and engineering specifications rather than through supervised learning from a labeled training dataset.
§ 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).