(273 days)
The MD300W628 Wrist Pulse Oximeter is a portable, non-invasive device intended to measure, display, store and transfer functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate (PR) of adult, adolescent and child in hospitals, clinics, long-term care, and home use.
The device intended for spot-checking and can be reused, not intended for continuous monitoring, use during motion or use with low perfusion.
The subject device Pulse Oximeter is an internally powered device. The main functions of the devices include hemoglobin oxygen saturation (SpO2), pulse rate (PR) measurements and Pulse amplitude index (PAI), data storage and transmission.
Place one fingertip into the sensor for diagnosis and the oxygen saturation (SpO2), pulse rate (PR) measurements and pulse amplitude index (PAI) will appear on the display. The device is normally applied to adult and pediatric patients in hospital and home care environment.
The subject device is composed of following components to achieve the above detection process: power supply module, detector and emitter, signal collection and process module (MCU), OLED display screen and Bluetooth module.
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. 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.
This FDA 510(k) summary provides information on the Beijing Choice Electronic Technology Co., Ltd. MD300W628 Wrist Pulse Oximeter, including its acceptance criteria and the studies conducted to demonstrate its performance.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The document relies on compliance with recognized standards for its acceptance criteria, particularly ISO 80601-2-61 for pulse oximeter equipment accuracy.
| Performance Metric | Acceptance Criteria (Standard/Range) | Reported Device Performance (MD300W628) |
|---|---|---|
| SpO2 Accuracy | $\text{ARMS} \leq 3.0%$ (standard for pulse oximeters) | $\text{ARMS} = 1.68%$ for SpO2 range 70-100% |
| SpO2 Display Range | Verified according to IEC 60601-1 and ISO 80601-2-61 requirements | $70% \sim 100%$ |
| PR Display Range | Verified according to IEC 60601-1 and ISO 80601-2-61 requirements | $30 \sim 250 \text{bpm}$ |
| PAI Accuracy | $0.3 \sim 1.0% (\pm 0.2 \text{digits})$; $1.1 \sim 20.0% (\pm 20%)$ | Test results available in System Test Report (specific values not detailed in summary) |
| Electrical Safety | Compliance with IEC60601-1, IEC 60601-1-11 | Conformed |
| EMC | Compliance with IEC60601-1-2 | Conformed |
| Biocompatibility | Compliance with ISO10993-1, ISO10993-5, ISO10993-10 | Met standard requirements |
| Software Validation | Compliance with FDA Guidance for Content of Premarket Submissions for Software Contained in Medical Devices | Compliant (Moderate level of concern) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Test (SpO2 Accuracy): 11 healthy adult volunteer subjects.
- Data Provenance: The clinical study was conducted at Yue Bei People's Hospital. The origin is inferred to be China, as Beijing Choice Electronic Technology Co., Ltd. is based in Beijing, China. The study appears to be prospective as it involved recruiting subjects and performing specific tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used or their qualifications for establishing ground truth. It mentions that the clinical study evaluated SpO2 accuracy "as compared to arterial blood CO-Oximetry." CO-Oximetry is the gold standard for measuring arterial oxygen saturation, and its results are considered highly accurate, typically not requiring expert interpretation for ground truth establishment in this context.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. Given that the ground truth for SpO2 accuracy was established using arterial blood CO-Oximetry, which is an objective measurement, an adjudication method for disagreements on ground truth would generally not be necessary for this specific performance metric.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted or of any effect size related to human readers improving with or without AI assistance. This device is a pulse oximeter, which provides direct physiological measurements, not interpretations that would typically involve multiple human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The SpO2 accuracy performance study described is essentially a standalone performance study. The device's measurement of SpO2 is directly compared to an objective gold standard (arterial blood CO-Oximetry), without human intervention in the interpretation of the device's output. The device itself (algorithm) provides the SpO2 reading.
7. Type of Ground Truth Used
The ground truth used for the SpO2 accuracy testing was arterial blood CO-Oximetry.
8. Sample Size for the Training Set
The document does not provide information on the sample size for a training set. Pulse oximeters typically rely on established optical principles and signal processing algorithms rather than machine learning models that require large training datasets in the same way AI algorithms for image analysis might. The "algorithm" here refers to the signal processing rather than a deep learning model.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of typical machine learning, there is no information on how ground truth for a training set 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).