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The MD300CA Fingertip Pulse Oximeter is a portable oximeter intended for spot-check use to non-invasively measure oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients at home and hospital settings (including clinical use by internists, during surgery, anesthesia, intensive care, etc.). Not for continuous monitoring.

The applicant device of Fingertip Pulse Oximeter MD300CA can display %SpO2, pulse rate value and vertical bar graph pulse amplitude. The applicant device consists of a detector and emitter LED, signal amplify unit, CPU, data display unit, and power unit. 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 ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount 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 applicant device has low battery voltage alarm function and automatically power of function. The power source of the applicant device is 1 button lithium battery.

The provided 510(k) summary for the Fingertip Pulse Oximeter MD300CA primarily focuses on demonstrating substantial equivalence to a predicate device (MD300C) based on design and safety considerations, rather than reporting on a standalone effectiveness study with detailed acceptance criteria and performance metrics typically found for novel devices.

However, it does mention that Clinical Test reports following ISO 9919:2005 were conducted to assess the accuracy of the MD300CA. While the specific acceptance criteria and detailed performance results from this clinical test are not fully enumerated in this summary, the document does state that the device's accuracy is in compliance to the requirement.

Here's a breakdown of the requested information based on the provided text, with limitations noted due to the nature of a 510(k) summary for a modified device:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly list numerical acceptance criteria with corresponding performance metrics for SpO2 accuracy. It generally states:

Note: ISO 9919:2005 typically specifies accuracy limits for SpO2 measurements within certain ranges (e.g., ±2% between 70-100% SpO2). The summary indicates the device met these, but the exact numerical results are not detailed.

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

• Sample Size for Test Set: Not explicitly stated in the provided summary. The summary refers to "Clinical Test reports following ISO 9919:2005," implying a clinical study was performed, but the number of subjects is not mentioned.
• Data Provenance: The clinical tests were "conducted in Laboratory of Beijing Friendship Hospital." This indicates the data is prospective and originated from China.

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

This information is not provided in the summary. For a pulse oximetry study, ground truth (reference SpO2) is typically established using a co-oximeter on arterial blood samples rather than expert review of images or data. The summary doesn't detail the method for establishing ground truth, only that the clinical tests followed ISO 9919:2005, which specifies the use of a reference co-oximeter for blood gas analysis.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used when human interpretation (e.g., of medical images) generates uncertain results that need consensus. For a device like a pulse oximeter, the comparison is typically between the device's reading and an objective reference standard (co-oximeter).

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

• Was it done? No, an MRMC comparative effectiveness study was not done. This type of study involves assessing the improvement of human readers (e.g., radiologists) when assisted by an AI system. The MD300CA is a standalone diagnostic device, not an AI assistance tool for human interpretation.
• Effect Size: Not applicable.

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

• Was it done? Yes. The "Clinical Test reports following ISO 9919:2005" represent a standalone performance study. The pulse oximeter measures SpO2 and pulse rate directly, without human interpretation of its output being part of the diagnostic chain in the way an AI image analysis tool would be. The clinical test evaluated the device's accuracy against a recognized standard.

7. Type of Ground Truth Used

Based on the reference to ISO 9919:2005 for pulse oximeter accuracy testing, the ground truth would typically be established by:

• Arterial Blood Gas Analysis (ABG) with a co-oximeter: Venous blood is oxygenated by various physiological maneuvers (e.g. oxygen breathing, reduced oxygen breathing) and arterial blood samples are taken. The oxygen saturation in these samples is measured by a laboratory co-oximeter, which serves as the reference standard (ground truth) for SpO2.

8. Sample Size for the Training Set

• Not Applicable / Not provided. For a hardware medical device like a pulse oximeter, there isn't typically a "training set" in the sense of machine learning algorithms. The device's algorithms for calculating SpO2 and pulse rate are based on established physiological principles and signal processing, not on training data. The development process involves calibration and verification using controlled experiments, but this is different from an AI training set.

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

• Not Applicable / Not provided. As mentioned above, there isn't a "training set" for this type of device. The underlying principles are established physiological models and physics of light absorption, verified through bench testing and clinical studies.

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