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Caremed Disposable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult, pediatric and infant patient populations.

The proposed device, Disposable SpO2 Sensors are accessories to the patient monitors, which are intended for continuous non-invasive monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is Nihon Kohden BSM-5135A. The sensor shall be connected to its corresponding monitor through Caremed adapter cable model SZ30-36. Oxygenation of blood is measured by detecting the infrared and red-light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin, which consists of a probe attached to the patient's finger. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. Red and infrared light lit alternately according to certain sequence, when the fingertips of capillary repeatedly with the heart pumps blood congestion, light emitting diode after blood vessels and projected onto a photodiode, photodiode can be induced to change with pulse light intensity, the electrical signals in the form of change. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. By measuring the wave crest of the pulse wave and the absorbance of the trough, SpO2 is calculated to obtain the correct oxygen saturation value. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

This document describes the performance data and acceptance criteria for the Disposable SpO2 Sensor (K191279).

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document states that "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Caremed Disposable SpO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry."
For the expanded indication to include infants (3 kg < weight < 15 kg), the document states, "This specification has been verified and validated according to ISO 80601-2-61: 2017 clause 201.12.1.101 SpO2 accuracy of pulse oximeter equipment."

• Sample Size: The exact number of human adult volunteers used for the clinical hypoxia test is not explicitly stated. Similarly, the sample size for the infant validation is not provided.
• Data Provenance: The general nature of the clinical hypoxia test in "human adult volunteers" suggests prospective data collection for the purpose of the study. The document does not specify the country of origin, but the submission sponsor is Shenzhen Caremed Medical Technology Co., Ltd. in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document mentions that "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Caremed Disposable SpO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry."

• Number of Experts: The document does not specify the number of experts used.
• Qualifications of Experts: The document does not specify the qualifications of the experts, other than implying they would be qualified to perform arterial blood gas measurements and co-oximetry.

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

The document does not provide information regarding any adjudication method used for the clinical test set data. The ground truth was established by co-oximetry.

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:

This device is a Disposable SpO2 Sensor, a medical device for physiological monitoring, not an AI-powered diagnostic imaging tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this submission.

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

The device itself is a sensor that generates measurements (SpO2 and pulse rate) which are then processed by an oximeter (patient monitor). The clinical testing assessed the accuracy of these measurements against a gold standard (co-oximetry), which effectively evaluates the "standalone" performance of the sensor's ability to accurately measure physiological parameters. There is no explicit mention of a "human-in-the-loop" component for interpretation of the SpO2 values that would differ from standard clinical practice with such devices.

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

The ground truth for the clinical accuracy study was established by arterial oxygen saturation (SaO2) as determined by co-oximetry. This is considered a gold standard for measuring blood oxygen levels.

8. The sample size for the training set:

Pulse oximetry devices typically do not have a "training set" in the context of machine learning algorithms for image interpretation or complex diagnostic tasks. Their performance is primarily based on the physical principles of light absorption by hemoglobin. While there might be internal calibration data or historical performance data used in the development of the device's signal processing algorithms, the document does not specify a training set sample size in the way it would be defined for AI/ML models.

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

As noted above, a distinct "training set" in the AI/ML sense is not applicable to traditional pulse oximetry devices. The ground truth for developing and calibrating the device's underlying principles and algorithms would be based on controlled experiments and physiological models that relate light absorption to blood oxygen saturation, typically validated against gold standard measurements like co-oximetry in a laboratory or controlled clinical setting. The document does not provide details on how this early-stage ground truth was established for the development of the device's core technology. The clinical studies mentioned are for validation of the final product.

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