(204 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 hospital-type facilities and homecare. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. The device is wearing on fingertips while using.
The subject device Pulse Oximeter is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. The device has 2 display modes. 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), LED 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 660nm, 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.
Here's a breakdown of the acceptance criteria and the study details for the Pulse Oximeter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from predicate/standards) | Reported Device Performance (Subject Device MD300C19) |
|---|---|---|
| SpO2 Accuracy | 70%~100%, ±2% | ARMS of 1.5% (over 70-100% SpO2 range) |
| SpO2 Display Range | 0~100% | 0~100% |
| SpO2 Measurement Range | 70%~100% | 70%~100% |
| SpO2 Resolution | 1% | 1% |
| PR Display Range | 30bpm~250bpm (Predicate) | 0bpm~255bpm |
| PR Measurement Range | 30bpm~250bpm | 30bpm~250bpm |
| PR Accuracy | 30bpm | 30bpm |
| PR Resolution | 1bpm | 1bpm |
| Operating Temperature | 5°C~40°C (Predicate) | 0°C~40°C |
| Biological Evaluation | ISO 10993-1, -5, -10 | Compliant (Biocompatibility tests done) |
| Electrical Safety | IEC60601-1, IEC60601-1-11 | Compliant |
| EMC | IEC60601-1-2 | Compliant |
| Software | FDA Guidance for Software in Medical Devices | Compliant |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 11 healthy adult volunteer subjects.
- Data Provenance: The study was conducted in a controlled clinical setting. The specific country of origin is not explicitly stated, but the manufacturer is based in China. The study was prospective in nature, as it involved actively recruiting subjects and conducting measurements to evaluate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications for establishing the ground truth. It states that the ground truth was obtained via "arterial blood CO-Oximetry," which is a laboratory method, not an expert assessment.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method involving experts for the test set. The ground truth was established through a direct objective measurement (arterial blood CO-Oximetry).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone performance of the Pulse Oximeter against an objective ground truth, not on evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, the study primarily assessed the standalone performance of the Pulse Oximeter (algorithm only, as it's a direct measurement device). The reported ARMS value of 1.5% is a measure of the device's accuracy in determining SpO2 levels without human interpretation beyond reading the display.
7. Type of Ground Truth Used
The ground truth used was arterial blood CO-Oximetry. This is considered a gold standard for measuring oxygen saturation in arterial blood.
8. Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. Pulse oximeters, particularly those based on established principles like spectrophotometry, often rely on physics-based algorithms and extensive calibration rather than machine learning models requiring large training datasets in the same way AI algorithms do.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, there is no information on how its ground truth was established.
§ 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).