(145 days)
The PO3M Fingertip Pulse Oximeter is a non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/surgery. anesthesia, intensive care, etc).
Our device PO3M Fingertip Pulse Oximeter is a fingertip device, which can measure the arterial SpO2 and pulse rate value and can display the results to the user.
It is a noninvasive measurement instrument with a pair of small light-emitting diodes (LEDs) facing a photodiode through a fingertip. One LED is red, with wavelength of 660 nm, and the other is infrared, 880 nm. The MCU calculates the ratio of these two wavelengths and get the results of the SPO2. At the same time, by examining only the varying part of the absorption spectrum, a monitor can ignore other tissues or nail, and discern only the absorption caused by arterial blood to detect the pulse rate.
The power source is Lithium-ion battery.
More over, the PO3M can transmit the measurement data to the iPhone, iPod Touch or iPad by wireless transmission.
The device is for prescription. It is neither for life-supporting nor for implanting. lt does not contain any drug or biological product and it does not need to be sterile.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| SpO2 measuring range: 70-99% | SpO2 measuring range: 70-99% |
| SpO2 Accuracy: ± 2% | SpO2 Accuracy: ± 2% |
| Pulse Rate Measuring Range: 30-250 bpm | Pulse Rate Measuring Range: 30-250 bpm |
| Pulse Rate Accuracy: ± 2 bpm (30-99 bpm) | Pulse Rate Accuracy: ± 2 bpm (30-99 bpm) |
| Pulse Rate Accuracy: ± 2% (100-250 bpm) | Pulse Rate Accuracy: ± 2% (100-250 bpm) |
2. Sample Size and Data Provenance
The document does not specify the sample size used for performance testing (e.g., test set for SpO2 and Pulse Rate accuracy). It states that the device was tested according to ISO 80601-2-61:2011, which likely involves human subject testing with controlled hypoxia. However, details of the number of subjects and their characteristics are not provided in this summary.
The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly stated.
3. Number and Qualifications of Experts for Ground Truth
This information is not provided in the document. For pulse oximetry, the ground truth for SpO2 accuracy is typically established by arterial blood gas analysis, which does not require expert adjudication in the same way imaging studies might.
4. Adjudication Method
This information is not applicable and therefore not provided, as the ground truth for pulse oximetry accuracy is derived from direct physiological measurements (e.g., arterial blood gas analysis) rather than subjective expert interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done, as this type of study is typically performed for diagnostic imaging devices where human interpretation is a key component. This device is a direct measurement device (pulse oximeter), not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance
Yes, a standalone (algorithm only without human-in-the-loop performance) study was done for the device's main function. The performance testing section (4. Performance Testing) indicates that the "device was tested according to ISO 80601-2-61: 2011" and found to meet all applicable requirements. This standard specifies requirements for pulse oximeter equipment, including accuracy measurements against a reference standard. The reported accuracy metrics for SpO2 and pulse rate are based on the device's direct measurements.
7. Type of Ground Truth Used
The ground truth used for performance assessment (SpO2 and pulse rate accuracy) is based on direct comparison to a reference method, typically arterial blood gas analysis for oxygen saturation. The ISO 80601-2-61 standard outlines these methods.
8. Sample Size for the Training Set
This information is not provided. Pulse oximeters are typically based on well-established physical principles of light absorption by hemoglobin, and their algorithms are often derived from theoretical models and empirical calibrations rather than extensive machine learning training sets in the modern sense. If any machine learning or adaptive algorithms are used, the training set details are not disclosed in this summary.
9. How the Ground Truth for the Training Set was Established
This information is not provided. As mentioned above, the underlying principles of pulse oximetry are generally not based on "training sets" in the context of supervised machine learning. If any calibration or algorithm development involved data, the method for establishing its ground truth is not detailed here.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).