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This Pulse Oximeter is intended for measuring the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check of SpO2, PR of adult or pediatric patients (weight >=40kg) in home. This device is not intended for continuous monitoring. It is intended to be used by both lay person or healthcare professional in the home environment.

The Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). 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 660 nm, which is red light; the other is 905 nm, which is Infrared 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 Pulse Oximeter is powered by 2 AAA alkaline batteries. The device mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, and plastic shell. The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.

The provided FDA 510(k) summary for the Pulse Oximeter (Model: PO101, PO102, PO103) includes information about acceptance criteria and a study to demonstrate performance.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Notes on the table:

• The document explicitly states the "SpO2 Accuracy" and "PR Accuracy" directly as acceptance criteria within the comparison table between the subject and predicate devices.
• The "Reported Device Performance" for these parameters is shown to match the acceptance criteria, indicating the device meets them.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated in the provided document. The document mentions "human adult volunteers" for the clinical hypoxia test.
• Data Provenance: Not explicitly stated in the provided document. The manufacturer and correspondent are based in China, but the location of the clinical study is not specified. The study was prospective in nature as it involved deliberately inducing hypoxia in human volunteers.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable in this context. The "ground truth" for oxygen saturation (SpO2) in pulse oximetry studies is typically established by arterial blood gas analysis (co-oximetry), not by expert consensus. The document states: "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Pulse Oximeter versus arterial oxygen saturation (SaO2) as determined by co-oximetry."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers interpret medical images or data and their interpretations need to be reconciled to establish a consensus ground truth. In pulse oximetry, the gold standard (co-oximetry) is an objective measurement, not subject to interpretation 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 type of study is relevant for AI-powered diagnostic tools where human readers are assisted by AI. The Pulse Oximeter is a standalone medical device that provides readings of SpO2 and PR, not an AI-assisted diagnostic tool for human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, a standalone performance study was done. The entire clinical study for the Pulse Oximeter is inherently a standalone performance evaluation, as the device itself is measuring SpO2 and PR, and its readings are compared against the gold standard (co-oximetry) without human interpretation in the loop impacting the device's measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The ground truth used was arterial oxygen saturation (SaO2) as determined by co-oximetry. This is considered the gold standard for measuring oxygen saturation directly from arterial blood.

8. The sample size for the training set

• Not applicable. This device is a traditional medical device, not an AI/machine learning model that requires a "training set" in the computational sense. Its performance is based on its physical and optical design, algorithms for signal processing, and calibration during manufacturing.

9. How the ground truth for the training set was established

• Not applicable, as there is no "training set" in the context of this traditional medical device.

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