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The MD300C318 Fingertip Pulse Oximeter is intended for continuous use or spot checking in measuring and displaying functional arterial oxygen saturation (SpO2) and pulse rate of patients in hospitals and home care. It is intended for adult and pediatric patients on finger between 0.3-1.0 inch (0.8 - 2.5 cm) thick.

The applicant device MD300C318 is a Finger Pulse Oximeter, which designed with the measurement, storage, review, audible alarms, visible alarms, vibration alert for finger-out, low battery voltage alarm function, and data transmission (optional) functions. The power source of the applicant device is 2*AAA Typical lithium ion batteries. The Pulse Oximeter consists of detector and emitter LED, signal amplify unit, CPU, data display unit and power unit, and with Bluetooth® communication which is integrated into a telemedicine system or other health data collection system through the wireless connection. 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 photodetector 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 device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does not need sterilization or re-sterilization. The device is for prescription. The device does not contain drug or biological products.

The provided 510(k) summary for the MD300C318 Fingertip Pulse Oximeter describes the device, its intended use, and claims substantial equivalence to a predicate device, but it does not explicitly detail specific acceptance criteria or a dedicated study proving these criteria were met in the way typically expected for a detailed performance study with defined metrics.

Instead, the submission states that the device is compliant with several standards and has undergone "human testing." The "Clinical Test reports following ISO 9919:2005" is mentioned, which is the most relevant piece of information pointing to how performance was assessed. ISO 9919:2005 specifies requirements for the safety and essential performance of pulse oximeters, and typically includes accuracy requirements for SpO2 and pulse rate.

Here's an attempt to extract and infer the requested information, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the format of a table with pass/fail values. It only refers to compliance with ISO 9919:2005.

Inferred from ISO 9919:2005 (General Requirements for Pulse Oximeters):

• Note: ISO 9919:2005 typically requires SpO2 accuracy (Arms, root mean square difference) to be within a certain limit (e.g., ±2% for adults/pediatrics) in the 70-100% saturation range, often evaluated through human desaturation studies. Pulse rate accuracy also has specific limits, often within ±1 or ±2 beats per minute. These specific numerical results are not provided in the given text.

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

The document states: "The applicant device has successfully undergone both bench and human testing to support the determination of substantial equivalence." and "The Clinical Test reports following ISO 9919:2005, Medical electrical equipment - Particular requirements for the safety and essential performance of pulse oximeter."

• Sample Size for Test Set: Not explicitly stated. Clinical tests for pulse oximeters following ISO 9919 often involve a minimum number of healthy volunteers (e.g., 10-15 subjects) for induced hypoxia studies to cover the full SpO2 range.
• Data Provenance: Not explicitly stated. Given the manufacturer is based in Beijing, China, it's plausible the human testing was conducted in China, but this is an inference, not a stated fact in the document.
• Retrospective or Prospective: Not explicitly stated. Human desaturation studies for pulse oximeter accuracy are typically prospective.

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

• Number of Experts: Not applicable/Not stated. For pulse oximeter accuracy studies, the "ground truth" for arterial oxygen saturation (SaO2) is typically established by co-oximetry measurements from arterial blood samples taken by trained medical professionals, not by "experts" reviewing images or data for consensus. For pulse rate, the ground truth is often established by ECG or direct arterial pressure monitoring.
• Qualifications of Experts: Not applicable/Not stated.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not stated. This concept (e.g., 2+1, 3+1) is typically used for subjective assessments where multiple readers interpret data and discrepancies are resolved. Pulse oximeter accuracy studies rely on objective measurements from reference devices (co-oximeter, ECG), not adjudicated interpretations.

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

• Was an MRMC study done? No. This type of study is not relevant for evaluating the standalone accuracy of a pulse oximeter. MRMC studies assess how human readers' diagnostic performance changes with and without AI assistance, which is not the purpose of this device's evaluation.
• Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone study was done. The "human testing" or "clinical test reports following ISO 9919:2005" specifically evaluates the device's (algorithm + sensor) ability to accurately measure SpO2 and pulse rate against a reference standard. This is a standalone performance evaluation by nature.

7. Type of Ground Truth Used

• Type of Ground Truth: Clinical Reference Standard. For SpO2, the ground truth is established using arterial blood gas analysis with a co-oximeter (SaO2). For pulse rate, the ground truth is typically obtained from an electrocardiogram (ECG) or arterial line. This is implied by adherence to ISO 9919:2005 standards.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not stated. Pulse oximeters typically use established physics-based algorithms and lookup tables, rather than machine learning models that require large training datasets in the conventional sense. The device's algorithm would be developed based on physiological models and potentially validated with internal data, but the concept of a "training set" as used in AI/ML is not directly applicable here.

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

• How Ground Truth for Training Set Was Established: Not applicable. As noted above, the device likely uses a physics-based algorithm. If any initial calibration or look-up table generation involved human data, the ground truth would similarly be established by a clinical reference standard (e.g., co-oximetry), but the document does not provide details on this development process.

In summary: The provided 510(k) summary confirms the device underwent human testing in compliance with ISO 9919:2005, which is the standard for pulse oximeter accuracy. However, it lacks specific numerical performance data, sample sizes for the clinical study, and explicit details on the ground truth establishment for that study, beyond stating compliance with the standard.

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