(274 days)
The Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent child and infant patients in hospitals, hospital-type facilities and homecare. The device can be used by the people whose finger thickness is between 8mm and 22mm(0.3 inches to 0.9 inches).
The proposed device, Pulse Oximeter, is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. The MD300C228 is adopted LCD screen to display to display SpO2, Pulse Rate value (PR), Perfusion Index (PI), pulse bar, brightness level, battery indicator, signal indicator and waveform, it has 7 display modes, the brightness level can be adjusted 1-5 level. The measured data can be transmitted to APP through Bluetooth. The device is normally applied to adult, adolescent child and infant patients in hospitals, hospital-type facilities and homecare.
The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter LED, signal collection and process module (MCU), LCD display screen, user interface and button control circuit.
Principle of the oximeter is as follows: The pulse oximeter works by applying a sensor to a fingertip. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660mm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector 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 enclosure of the subject device is made of ABS and the fingertip cushion is made of Silicone Gel.
The subject device is not for life-supporting or life-sustaining, not for implant.
The device is not sterile, and the transducers are reusable and do not need sterilization and re-sterilization.
The device is for prescription.
The device does not contain drug or biological products.
The provided text describes the acceptance criteria and a clinical study conducted for the Pulse Oximeter MD300C228. This device is a pulse oximeter, not an AI/ML device, so certain requested details such as number of experts for ground truth, adjudication methods, MRMC studies, and training set information are not applicable in this context. However, I will extract and present the relevant information provided for this medical device.
Acceptance Criteria and Device Performance:
The primary performance metric mentioned is SpO2 accuracy.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| SpO2 Accuracy | Arms of 1.8 during steady state conditions over the range of 70-100% SaO2. |
| SpO2 Display Range | 0%~100% |
| SpO2 Measurement Range | 70%~100% (Accuracy defined for 70-100%, no definition for 0-69%) |
| SpO2 Resolution | 1% |
| PR Display Range | 30 bpm~250 bpm |
| PR Measurement Range | 30 bpm~250 bpm |
| PR Accuracy | 30 bpm |
| PR Resolution | 1 bpm |
| PI Display Range | 0.1%~20% |
| PI Measure Range | 0.3~20.0% |
| PI Resolution | 0.1% |
| Working Time | Continuously operated as long as 20 hours |
| Operating Temperature | 0°C~40°C |
Study Details:
-
Sample Size and Data Provenance:
- Sample Size: 11 healthy adult volunteer subjects (ages 20-42yr, with light to dark pigmentation, including male and female).
- Data Provenance: The document does not explicitly state the country of origin for the clinical study, but the manufacturer is based in Beijing, China. The study appears to be prospective, as it involved inducing hypoxia in volunteers to collect data.
-
Number of Experts and Qualifications for Ground Truth:
- This criterion is not applicable as the "ground truth" for SpO2 accuracy was established through direct measurement using a reference co-oximeter, not through expert consensus or interpretation of images.
-
Adjudication Method:
- Not applicable, as the ground truth was based on direct co-oximeter measurements, not subjective evaluations requiring adjudication.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is a study to validate the accuracy of a standalone pulse oximeter device, not an AI-assisted diagnostic tool for human readers.
-
Standalone Performance:
- Yes, a standalone performance study was conducted. The clinical study aimed to evaluate the SpO2 accuracy performance of the pulse oximeter during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels as compared to arterial blood co-oximeter. The reported Arms of 1.8% is a measure of the device's standalone accuracy.
-
Type of Ground Truth Used:
- Physiological Measurement/Reference Device: The ground truth for SpO2 accuracy was established by analyzing arterial blood samples with a reference co-oximeter, providing functional SaO2.
-
Sample Size for Training Set:
- Not applicable. This is a hardware pulse oximeter device, not an AI/ML algorithm that requires a training set. The device's performance is based on its optical and signal processing design.
-
How Ground Truth for Training Set was Established:
- Not applicable as there is no training set for this type of device.
§ 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).