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The Fingertip Pulse Oximeter MD300CL37 is a portable, 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 home environments.

The proposed device of Fingertip Pulse Oximeter MD300CL37 is a battery powered fingertip device, which can detect, display the measured %SpO2 and pulse rate value. The device is normally applied to adult, adolescent, child and infant patient in hospitals, hospital-type facilities, and home environments.

The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module and user interface.

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 one wavelength of light source is 660nm, which is red light; the other is 940nm, which is ultra red 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 device are 2 AAA alkaline batteries. The proposed device have low battery voltage indicator function and the proposed device will automatically power off when there is no signal for longer than 8 seconds. When the finger is placed into the device, the device will be powered on automatically.

The proposed device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does not need sterilization or re-sterilization. The device is for prescription. The device does not contain drug or biological products.

The device is software-driven and the software validation is provided in Section of Software.

The document provided describes the Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter MD300CL37 and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Note: While the document lists "Acceptance Criteria (Predicate Device)" as directly matching the predicate's performance, the primary acceptance criteria for the new device would be to demonstrate performance comparable to the predicate within accepted margins, often specified by standards like ISO 80601-2-61.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 12 healthy adult volunteer subjects.
• Data Provenance: The study was conducted in China ("Yue Bei People's hospital" is mentioned as the location of the clinical test, which is a hospital in China). It was a prospective study where subjects were intentionally exposed to induced hypoxia.

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 or their qualifications directly involved in establishing the ground truth. It states that "Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on Reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison." This implies that the ground truth was established by direct physiological measurement using a reference CO-Oximetry device, which is a gold standard for blood oxygen saturation. The expertise would lie in the laboratory personnel operating the CO-Oximetry and the medical staff conducting the induced hypoxia and blood draws, though specific qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set. The ground truth was established by direct comparison to a reference CO-Oximetry device. This is a direct measurement comparison, rather than an expert consensus that would typically require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on the device's standalone accuracy against a reference measurement.

6. Standalone Performance

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done for the device's accuracy. The clinical test directly compared the device's SpO2 readings to functional SaO2 measured by reference CO-Oximetry.

7. Type of Ground Truth Used

The ground truth used was physiological measurement obtained from Reference CO-Oximetry of arterial blood samples.

8. Sample Size for the Training Set

The document does not specify a sample size for a "training set." This type of premarket notification (510(k)) primarily demonstrates substantial equivalence to a legally marketed predicate device, often relying on established principles and clinical validation rather than a deep learning model's training set. The clinical study described is for validation.

9. How the Ground Truth for the Training Set Was Established

As no specific training set is discussed for an AI/algorithm in the context of this device's submission, how its ground truth was established is not applicable or detailed in the provided document. The device is a traditional sensor-based medical device, not a machine learning algorithm requiring a separate training phase in the AI sense.

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