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The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.

The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2). The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery.

The provided document is a 510(k) summary for the Shenzhen Yimi Life Technology Co., Ltd. Pulse Oximeter (various models). It details the device's characteristics and its substantial equivalence to a predicate device. Here's an analysis of the acceptance criteria and the study information as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly refers to acceptance criteria for SpO2 accuracy and Pulse Rate accuracy based on the ISO 80601-2-61 standard.

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

• Sample Size: The document does not specify the exact sample size for the clinical test set. It only states that "Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011". Annex EE of ISO 80601-2-61 generally recommends a minimum of 10 healthy subjects for SpO2 accuracy testing, though more may be required depending on the specific design of the study and the range of SpO2 values assessed.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a Chinese manufacturer, the clinical testing was likely conducted in China or a similar jurisdiction following international standards. The nature of SpO2 accuracy testing typically involves prospective studies where subjects are intentionally desaturated under controlled conditions.

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 for establishing ground truth in the clinical test set. For pulse oximetry, the ground truth for SpO2 accuracy is typically established by co-oximetry measurements from arterial blood samples, which does not directly involve "experts" in the sense of clinical reviewers for image analysis. The "ground truth" (reference standard) in this context is the quantitative co-oximetry reading.

4. Adjudication Method for the Test Set

Not applicable in the context of pulse oximetry SpO2 accuracy testing. Ground truth is established by objective co-oximetry measurements, not through expert consensus or adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is evaluated. Pulse oximeters provide a direct numerical output (SpO2 and pulse rate), so MRMC studies are not applicable.

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

Yes, a standalone performance study was done. The entire premise of the SpO2 accuracy testing described (clinical data per ISO 80601-2-61 Annex EE) is to evaluate the device's ability to accurately measure oxygen saturation and pulse rate independently, without human interpretation influencing the measurement. The device's output is compared directly against the reference standard (co-oximetry).

7. Type of Ground Truth Used

The ground truth used for SpO2 accuracy testing is co-oximetry measurements from arterial blood samples. This is the gold standard for determining actual arterial oxygen saturation. For pulse rate, the ground truth would typically be from an ECG monitor or a reference pulse rate measurement device.

8. Sample Size for the Training Set

The document does not provide information about a "training set" or its sample size. Pulse oximeters traditionally rely on established physiological principles and algorithms (e.g., Beer-Lambert law and pulsatile blood flow), rather than machine learning models that require extensive training data in the same way an AI image analysis algorithm would. Therefore, a distinct "training set" as understood in AI/ML development is not typically applicable for this type of device.

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

As no training set is described, this question is not applicable. The device's underlying principles are physics-based, and its performance is validated against physiological standards with direct measurements.

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