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This Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It is indicated for adult patients in home and hospital environment. The device is not intended for continuous monitoring, use during motion or use with low perfusion.

The Fingertip Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Fingertip 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 is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The Fingertip Pulse Oximeter is powered by 2 AAA batteries. The device mainly composed of PCB board, one key, OLED&LED screen, battery compartment, and plastic shell. The device is a spot-check Fingertip Pulse Oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.

Here's a breakdown of the acceptance criteria and study information for the Fingertip Pulse Oximeter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

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."

• Sample Size for Test Set: The exact number of human adult volunteers is not specified in the provided text.
• Data Provenance: The study involved human adult volunteers, suggesting a prospective study. The country of origin is not explicitly mentioned.

3. Number of Experts and Qualifications for Ground Truth

• The document mentions "co-oximetry" as the method for determining arterial oxygen saturation (SaO2) which is the ground truth. This is an objective measurement from a laboratory instrument.
• No information is provided about the number of experts or their qualifications as establishing ground truth was done through a laboratory instrument (co-oximetry), not subjective expert assessment.

4. Adjudication Method for the Test Set

• Since ground truth was established through objective co-oximetry measurements, an adjudication method like 2+1 or 3+1 by human experts is not applicable and therefore not mentioned.

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

• No MRMC study was done. This device is a standalone measurement device (Fingertip Pulse Oximeter) and does not involve human readers interpreting output with or without AI assistance. The performance evaluation focuses on the device's accuracy against a gold standard (co-oximetry) in measuring SpO2 and pulse rate.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• Yes, a standalone performance study was done. The entire clinical study described is focused on the device's inherent accuracy in measuring SpO2 and pulse rate without human intervention beyond application of the device and co-oximetry measurement.

7. Type of Ground Truth Used

• The ground truth used was outcomes data (specifically, arterial oxygen saturation (SaO2) as determined by co-oximetry). Co-oximetry is considered a highly accurate and objective method for measuring arterial oxygen saturation.

8. Sample Size for the Training Set

• Not applicable / Not explicitly mentioned. The provided document describes a premarket notification (510(k)) for a medical device that measures physiological parameters. It does not indicate the use of machine learning or AI models that would typically require a training set. The device appears to operate based on established physiological principles and signal processing algorithms, not a deep learning model.

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

• Not applicable. As mentioned above, there is no indication of a training set for machine learning in this context.

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