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The MD300W4 wrist pulse oximeter is a portable non-invasive device intended for spot checking ,data collection and recording of arterial oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at home and hospital( including clinical use in internist/ surgery, Anesthesia, intensive care and etc).

The proposed device MD300W4 consists of MCU circuit, power supply circuit, SpO2 module circuit, display circuit, Flash memory circuit, GPRS module circuit, charging circuit, real-time clock circuit, button circuit.
It can measure, store, review and display the SpO2% and pulse rate value, time, ID number, pulse bar and battery power status, the connection of probe, and transmit data by GPRS or USB cable.
The power supply is 4.2V Li-battery with capacity 1250mAh. The device can not be used to measure when it charges for the Li- battery.
The Pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and a photodetector. The one wavelength of 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 probe 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 proposed device has one model detachable sensor as the accessory of which the skin-contacting material is silicon. It is listed below:
M-50G (510(k) number: K082487)
The proposed device is not for life-supporting or life-sustaining, not for implant. The device or probe is not sterile 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 14 Software on page 14-1.

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Acceptance Criteria and Device Performance Study for Wrist Pulse Oximeter MD300W4 (K122046)

Based on the provided 510(k) summary, the device is a modified Wrist Pulse Oximeter, MD300W4, and its performance is evaluated against the predicate device, MD300W (K081125), and established standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MD300W4 are largely aligned with its predicate device and industry standards for pulse oximeters. The reported device performance is presented as compliance with these specifications.

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

• Sample Size for Test Set: 12 health adults.
• Data Provenance: Prospective clinical test conducted in Yue Bei People's Hospital. The country of origin can be inferred as China, given the manufacturer's location and the hospital name.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not specify the number of experts or their qualifications for establishing the ground truth. It states that SpO2 values were compared to "arterial blood sample oxygen saturation (functional SaO2) as measured by CO-Oximetry," referring to this as the "Golden Standard Co-Oximeter." This implies a technical measurement-based ground truth rather than expert consensus on subjective interpretations.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. The ground truth is established directly by a "Golden Standard" Co-Oximeter for arterial blood sample oxygen saturation, rather than through subjective expert review requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a pulse oximeter, which directly measures physiological parameters (SpO2 and pulse rate) and does not involve "human readers" interpreting images or data in the context of an "AI" system that would enhance human performance. The study described is a clinical accuracy study comparing the device's readings against a reference method.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done. The clinical test described involved comparing the device's SpO2 measurements directly against arterial blood sample oxygen saturation measured by a CO-Oximeter. This assesses the device's algorithmic performance in isolation (determining SpO2 from its sensor input) without human intervention in the measurement process itself, beyond the initial setup.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The type of ground truth used was objective measurement data from a "Golden Standard" Co-Oximeter measuring functional SaO2 from arterial blood samples. This is considered a highly accurate and direct physiological measurement.

8. The Sample Size for the Training Set

The document does not mention a separate training set or its sample size. The clinical test described appears to be for validation/testing, not for training a machine learning model. For a traditional medical device like a pulse oximeter, the core algorithm for converting optical signals to SpO2 and PR is typically based on established physiological models and calibration, rather than iterative machine learning training on a large dataset in the way an AI diagnostic algorithm would be.

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

As no separate training set is mentioned (or implied as relevant for this type of device's core function), the method for establishing ground truth for a training set is not applicable based on the provided information.

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