(182 days)
The Fingertip Pulse Oximeters, MD300C series, are portable, non-invasive devices intended for spot checking of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at hospital (including clinical use in internist/surgery, Anesthesia, and intensive care units).
The proposed devices of Fingertip Pulse Oximeters MD300C series are fingertip devices, which can display SpO2 and pulse rate value.
The proposed devices consist of detector and emitter LED, signal amplify unit, CPU, display unit and power unit.
The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The wavelength of one light source is 660 nm, which is red light; the other is 940 nm, which is infrared light.
Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.
The power sources of the proposed devices are 2 AAA alkaline batteries. All of the proposed devices have low battery voltage indicator function and all of the proposed devices will automatically power off when there is no signal for longer than 8 seconds.
The proposed devices of MD300CF3 and MD300CF61 have pulse rate tone modulation function. The function of pulse rate tone modulation is that the device can make a sound of Di-Di-Di to reflect pulse rate in real time.
The proposed devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization or re-sterilization. The devices are for prescription. The devices do not contain drug or biological products.
The Fingertip Pulse Oximeters MD300C series share the same measurement principle and oximeter sensor and oxygen saturation module and power supply. The indented target population and use environment of the Fingertip Pulse Oximeters MD300C series are the same.
The devices are software-driven and the software validation is provided in Section of Software
Here's a summary of the acceptance criteria and the study details for the Fingertip Pulse Oximeter MD300C series, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Stated) | Reported Device Performance (MD300C models vary, using a representative example or range from table 3-1) |
|---|---|---|
| SpO2 Accuracy | ±2% for 70%-99% | Model MD300C1/MD300C61: ±2% for 70%-99% |
| Model MD300C2/MD300CF3/MD300CF61/MD300C63: ±2% for 70%-100% | ||
| SpO2 Resolution | 1% | 1% for all models |
| Pulse Rate (PR) Accuracy | ±2BPM for 30~99BPM | ±2BPM for 30~99BPM for all models |
| ±2% for 100~235BPM | ±2% for 100~235BPM for all models | |
| PR Resolution | 1BPM | 1BPM for all models |
| SpO2 Measurement Range | 70%-99% or 70%-100% | 70%-99% (MD300C1/MD300C61) or 70%-100% (MD300C2/MD300CF3/MD300CF61/MD300C63) |
| PR Measurement Range | 30~235BPM | 30~235BPM for all models |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 12 healthy adult volunteer subjects.
- Data Provenance: Prospective clinical test conducted in the lab of the first affiliated hospital, Sun Yat-sen University. The country of origin can be inferred as China, given the manufacturer's location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number or qualifications of 'experts' in the context of establishing ground truth in the traditional sense of medical image interpretation by radiologists. Instead, the ground truth for SpO2 was established using instrumental analysis:
- Ground Truth Method for SpO2: Arterial blood samples were drawn and immediately analyzed on Reference CO-Oximetry to provide functional SaO2.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. Given the direct instrumental measurement of SaO2 via CO-Oximetry, clinical expert adjudication (like 2+1 reading) is not applicable or mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement
No, an MRMC comparative effectiveness study was not conducted. The study focused on the standalone performance of the device's SpO2 accuracy against a reference standard.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance study was conducted. The clinical test evaluated the accuracy of the MD300C63 Fingertip Pulse Oximeter in measuring SpO2 and pulse rate. The accuracy claimed by the manufacturer was supported by the study results.
7. The Type of Ground Truth Used
The ground truth used for SpO2 accuracy was reference CO-Oximetry analysis of arterial blood samples (functional SaO2).
8. The Sample Size for the Training Set
The document does not provide information on the sample size for a training set. Pulse oximeters, like the one described, are typically developed based on established optoelectronic principles and verified through clinical studies rather than machine learning models that require distinct training sets (unless specific AI/ML algorithms are integrated, which is not indicated here).
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned or suggested for an AI/ML context, the method for establishing ground truth for a training set is not applicable based on the provided text. The device's accuracy is validated through the clinical test described, which serves as a verification process against established clinical standards.
§ 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).