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The Fingertip Pulse Oximeters, MD300C series, are portable, non-invasive devices intended for spot checking of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at home and hospital (including clinical use in internist/surgery, Anesthesia, and intensive care units). Not for continuous monitoring.

The applicant devices of Fingertip Pulse Oximeters MD300C series are fingertip devices, which can display % SpO2 and pulse rate value.

The applicant devices consist of detector and emitter LED, signal amplify unit, CPU, data display unit and power unit.

The 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 mm, 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 over time. The photodetector in fingersensor 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.

The power source of the applicant devices is 2 AAA alkaline batteries. The applicant devices of MD300C3/ MD300CF3/ MD300C310 have pulse beep and sound tips function. The applicant devices of MD300C9111/ MD300C9211 have a USB port which can connect external probe.

The applicant devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization or re-sterilization. The devices are for prescription. The devices do not contain drug or biological products.

The devices are software-driven and the software validation is provided in Section 10 Software.

This document describes modifications to the Fingertip Pulse Oximeter MD300C series and the associated testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the accuracy of the proposed device (MD300C9111) is compliant with the specifications claimed by the manufacturer compared with the "Golden Standard" Co-Oximeter. While specific numerical acceptance criteria (e.g., A_rms value) are not provided in this summary, compliance with ISO 9919:2005 is the overarching acceptance criterion for pulse oximeter accuracy. The study's conclusion indicates that this criterion was met.

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

• Sample Size: 15 healthy adult subjects.
• Data Provenance: The clinical test was conducted in the lab of Beijing Friendship Hospital. It is a prospective study because healthy adults were enrolled specifically for this test. The country of origin of the data is China.

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 or qualifications of experts involved in establishing the ground truth. It states that the "Golden Standard" Co-Oximeter was used for comparison, implying that the Co-Oximeter readings themselves served as the ground truth. The operation and interpretation of a Co-Oximeter would typically be performed by trained medical professionals, but this detail is not provided.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The ground truth was established by direct comparison with a "Golden Standard" Co-Oximeter.

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

No, an MRMC comparative effectiveness study was not done. This device is a pulse oximeter, which directly measures physiological parameters and does not involve human readers for interpretation in the same way as an imaging AI device would.

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

Yes, a standalone performance study was done. The clinical test involved comparing the SpO2 readings of the MD300C9111 directly with the Co-Oximeter SaO2 values. There's no mention of a human-in-the-loop component for the device's core SpO2 measurement function during this test. The device provides a direct measurement.

7. The Type of Ground Truth Used

The type of ground truth used was "Golden Standard" Co-Oximeter SaO2 values. This is a direct physiological measurement considered the gold standard for arterial oxygen saturation.

8. The Sample Size for the Training Set

The document does not provide information on a training set sample size. This type of device (pulse oximeter) typically relies on established physiological principles and sensor technology, rather than machine learning models that require extensive training data. Therefore, a "training set" in the context of machine learning might not be applicable here.

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

As noted in point 8, there is no mention of a training set or how ground truth for such a set would have been established, as the device's operation is based on direct physical principles.

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