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MD300W512 / MD300W314/ MD300W314B4 is a wrist pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, adolescent, child and infant patients. It is intended for spot-check and / or data collection, recording and transmitting. It can be used in sleep labs, long-term care, hospitals and home use.

The proposed devices Wrist Pulse Oximeter MD300W512 /MD300W314/MD300W314B4 are internally powered devices. The main functions of the devices include hemoglobin oxygen saturation (SpO2) and pulse rate (PR) measurements, visual and audible indication, data storage and transmission. The proposed device MD300W512/MD300W314/MD300W314B4 consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface, button control circuit, data storage and transmission module.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance

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

• Sample Size: 12 healthy adult volunteer subjects.
• Data Provenance: The study was conducted in a hospital setting (Yue Bei people's Hospital) to evaluate the SpO2 accuracy performance of the MD300W512 Wrist Pulse Oximeter and its supporting M-50G010CS03 Oximeter probe. The text does not specify the country of origin but implies China, as the manufacturer is based in Beijing, China, and the hospital name is in Chinese. The study was prospective in nature, involving induced hypoxia and simultaneous blood sample collection.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. It mentions that "Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on Reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison." This implies that the reference CO-Oximetry results serve as the ground truth, which would typically be operated by trained medical professionals in a laboratory setting.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The ground truth was established by direct measurement using Reference CO-Oximetry, which is a quantitative and objective method, rendering adjudication for this specific ground truth less relevant than for subjective interpretations.

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

No MRMC comparative effectiveness study was done. The study focuses on the standalone performance of the device against a reference standard.

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

Yes, a standalone performance study was conducted. The Wrist Pulse Oximeter directly measures and displays SpO2 and pulse rate. The clinical test evaluated the device's accuracy directly against a reference CO-Oximetry, without human interpretation as part of the primary measurement.

7. Type of Ground Truth Used

The ground truth for SpO2 accuracy was established using Reference CO-Oximetry analysis of arterial blood samples. This is an objective, gold-standard method for determining arterial oxygen saturation (SaO2).

8. Sample Size for the Training Set

The document provided does not specify a separate training set or its sample size. The description pertains to the clinical test set used for validation of the device's performance.

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

As no training set is explicitly mentioned or detailed in the provided text, the method for establishing its ground truth is not available from this document. The document describes the ground truth for validation (test set) as being established by Reference CO-Oximetry.

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