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Fingertip Pulse Oximeter A310 is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in hospitals.

Fingertip Pulse Oximeter A310 is a battery powered device intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Finger 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 940 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. This equipment mainly composed of PCB board, On/Off button, mode button, OLED screen, battery compartment, and plastic shell. The device is a spot-check pulse oximeter and does not include alarms. The device does not support the measurement in the condition of low perfusion. The device is not intended for life-supporting or life-sustaining. The device is reusable and does not need sterilization.

Here's a breakdown of the acceptance criteria and study details for the Fingertip Pulse Oximeter A310, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

Note: The document explicitly states the SpO2 accuracy is ±3% for the range 70-100%, and the reported RMS values are all less than 3%, thus meeting this criterion. For Pulse Rate (PR) accuracy, the document states "complies with the declaration of specification at the normal condition," implying that the device met the stated accuracies of ±2 bpm (30-99 bpm) and 2% (100-235 bpm).

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

• Sample Size for Test Set: 12 healthy adult volunteers (8 men, 4 women).
• Data Provenance: The study was a clinical evaluation conducted on human subjects, implying a prospective study design. The country of origin is not explicitly stated, but the company is based in Milpitas, California, USA, suggesting the study likely took place in the USA or under US regulatory standards.

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

The ground truth for SpO2 was established using a laboratory CO-Oximeter on blood samples. While this is a highly accurate method, the document does not specify if human experts (e.g., lab technicians, doctors) were involved in interpreting or validating the CO-Oximeter results, or their specific qualifications if they were. The CO-Oximeter itself serves as the 'expert' in this context.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for SpO2 was derived directly from blood samples analyzed by a CO-Oximeter, which provides objective measurements. There was no mention of multiple human readers or a consensus process for the SpO2 ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted. This study focused on the standalone accuracy of the device against a CO-Oximeter, not on how human readers' performance might improve with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was conducted. The clinical evaluation directly compared the SpO2 readings from the Fingertip Pulse Oximeter A310 (algorithm only, as it's a non-invasive device for automated measurement) against the ground truth established by a laboratory CO-Oximeter.

7. The Type of Ground Truth Used

The type of ground truth used for SpO2 accuracy was direct physiological measurement via a laboratory CO-Oximeter on arterial blood samples (SaO2). This is a highly accurate and objective form of physiological reference.

8. The Sample Size for the Training Set

The document does not mention a training set or any details about a training process for the device's algorithm. For pulse oximeters, the core technology relies on established physical principles of light absorption by oxygenated and deoxygenated hemoglobin, rather than machine learning models that require explicit training sets. The "accuracy" is typically about calibration and hardware/software performance within these physical limits.

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

Not applicable, as no training set was mentioned.

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