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The Fingertip Pulse Oximeter MD300CB3 is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent, child and infant patient in hospital.

The applicant device of Fingertip Pulse Oximeter MD300CB3 is a battery powered fingertip device, which can detect and display the measured %SpO2 and pulse rate value, pulse bar graph and SpO2 waveform. The device is normally applied to adult, adolescent, child and infant patient in hospital. The applicant device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit. 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 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 over time. The photo detector in finger sensor 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 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 Software.

This document describes the FDA 510(k) submission for the Fingertip Pulse Oximeter MD300CB3. The acceptance criteria and the study used to meet them are detailed below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The predicate device's specific SpO2 accuracy is given as a single value (±3% for 70-99%). The applicant device provides a breakdown across different ranges, all of which fall below or within the ±3% range, indicating superior or equivalent accuracy in those segments. The "no definition" for 0-69% SpO2 is a shared characteristic. Other performance metrics for the predicate (PR accuracy, ranges, resolutions) are not explicitly stated with numerical values in the "Comparison with the Predicate Device" table for direct comparison, but the document states "The applicant device has similar device specifications as the predicate device," implying they meet equivalent performance standards.

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

• Sample Size for Test Set: Not explicitly stated as a number of subjects. The document mentions "clinical test for device accuracy is conducted in the Yue Bei people's Hospital." The specific number of patients or recordings used to determine the SpO2 accuracy (Arms) values (1.94, 2.32, 1.95, 1.57) is not provided in this summary.
• Data Provenance: Prospective clinical study conducted in Yue Bei people's Hospital, P.R. China.

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

• This information is not provided in the given text. The ground truth ("Golden Standard" Co-Oximeter) is directly measured by an instrument, not established by human experts.

4. Adjudication Method for the Test Set

• This information is not applicable as the ground truth is established by a "Golden Standard" Co-Oximeter, not through human expert consensus requiring adjudication.

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

• A MRMC comparative effectiveness study was not performed. This device is a standalone measurement device (pulse oximeter), not an AI-assisted diagnostic tool that would involve human readers.

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

• Yes, a standalone performance evaluation was conducted for the device. The clinical study directly assessed the device's accuracy against a "Golden Standard" Co-Oximeter without human interpretation being part of the measurement process. The device's SpO2 and PR measurements are automatically generated.

7. The Type of Ground Truth Used

• Instrumental Ground Truth: The ground truth for the clinical accuracy test was established using a "Golden Standard" Co-Oximeter, as stated: "accuracy of the proposed device is compliance to the specification claimed by the manufacturer compared with "Golden Standard" Co-Oximeter."

8. The Sample Size for the Training Set

• This device does not appear to employ machine learning or AI models that would require a separate "training set" in the conventional sense. It is a traditional medical device based on established physical principles. Therefore, this information is not applicable/not provided.

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

• As noted above, there is no mention of a training set for machine learning. The device's operation relies on direct physiological measurement and signal processing algorithms, not a learned model from a training set. Therefore, this information is not applicable/not provided.

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