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The external pulse oximeter (MD50i and MD50p) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult at hospital. This medical device can be reused. Not for continuous monitoring.

The MD50I includes three main parts as SpO2 probe, SpO2 module and 30 pin port. The SpO2 probe is used to collect the SpO2 and PR signal from the patient, the SpO2 module is used to process the signal from the probe and transform it to digital signal, the 30 pin port is used to connect with iPhone device for digital signal transmission.

The MD50I includes two parts of software, Upper Computer software (Mobile App) and Low Computer Software.

The Upper Computer software is installed in the iPhone device, which is used to receive the measured data (SpO2 and PR) from the MD50I, which has the following functions:

• Measured data (SpO2 and PR) receiving;
• Display the measured data (SpO2 and PR) in real time;
• Graph of the measured data (SpO2 and PR) based on the day/week/month or all of observed data trend.
• Measured data (SpO2 and PR) reviewed, the day/week/month history data could be reviewed;
• Note function, the user can make comments after specified history record;
• History data delete, the user can delete the history records;
• Personal information edit, the user can input their own information and save it;
• Share function, the user can select the specified history record to share with others by email;

The Low computer software is embedded in the MD501, which includes the SpO2 sensor and has the following functions:

• Collect the SpO2 and PR data from patient;
• Transform the electrical signal to digit signal;
• Send the digit signal to the Upper Computer software for display and following process.

The MD50P includes three main parts as SpO2 probe, SpO2 module and USB plug. The SpO2 probe is used to collect the SpO2 and PR signal from the patient, the SpO2 module is used to process the signal from the probe and transform it to digital signal, the USB is used to connect with PC device for digital signal transmission.

The MD50P includes two parts of software. Upper Computer software (PC App) and Low Computer Software.

The Upper Computer software is install in the PC device, which is used to receive the measured data (SpO2 and PR) from the MD50P, which has the following functions:

• Insert device identified automatically;
• Measured data (SpO2 and PR) receiving;
• Display the measured data (SpO2 and PR) in real time;
• Oxygen saturation, Pulse rate, Pulse bar and waveform are clearly displayed on PC when doing real-time measuring;
• Save the current data into your PC with the format of "txt", "pdf", "xls";
• Data print;
• Personal information edit, the user can input their own information and save it, such as title, patient ID, name, gender, age, height, weight, physician comments;
• Alarm set, set the high/low SpO2 limit and high/low PR limit;
• Saved data reviewed.
• Login interface, the user needs input password and user name to access the account.

The Low computer software is embedded in the MD50P, which includes the SpO2 sensor and has the following functions:

• Collect the SpO2 and PR data from patient;
• Transform the electrical signal to digit signal;
• Send the digit signal to the Upper Computer software for display and following process.

Here's a summary of the acceptance criteria and study information for the External Pulse Oximeter Models MD50I and MD50P, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Clinical Study Test Set Sample Size:
  • For MD50I: 11 subjects (out of 12 initially included, 1 excluded due to unstable pulse rate).
  • For MD50P: 11 subjects (out of 12 initially included, 1 excluded due to unstable pulse rate).
• Data Provenance: The studies were conducted in accordance with international standards (EN ISO 14155-1:2009, EN ISO 14155-2:2009, ISO 9919:2005, EN ISO 9919:2009, BS EN ISO 80601-2-61:2011) and FDA guidance for pulse oximeters. The text does not explicitly state the country of origin for the clinical trial data, but the manufacturer is Beijing Choice Electronic Technology Co., Ltd, China. The studies involved "healthy adult volunteer subjects" and data collection occurred during specified dates in July 2013. This indicates a prospective collection of data for the purpose of the clinical validation.

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

• The clinical studies for SpO2 accuracy used arterial blood CO-Oximetry for ground truth. This is a direct measurement, and therefore, no human experts were used to establish the ground truth for SpO2 accuracy in the clinical trial.

4. Adjudication Method for the Test Set:

• Not applicable, as ground truth for SpO2 accuracy was established via arterial blood CO-Oximetry, not human expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. The document describes non-clinical performance tests and clinical validation for the device's accuracy in measuring SpO2 and PR, not a study evaluating human reader performance with or without the device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

• Yes, the clinical accuracy studies (for both MD50I and MD50P) were standalone performance evaluations of the device's SpO2 accuracy against a reference method (CO-Oximetry), without human intervention in the loop of the measurement and calculation process. The non-clinical simulator tests also represent standalone performance.

7. The Type of Ground Truth Used:

• Clinical Trial Ground Truth: Arterial blood CO-Oximetry was used to provide functional SaO2, serving as the ground truth for SpO2 accuracy comparison.
• Non-Clinical Test Ground Truth: An SpO2 simulator was used to provide known SpO2 and PR values.

8. The Sample Size for the Training Set:

• The document does not provide information regarding a "training set" or its sample size. The studies described are validation or test sets for the device's accuracy. Pulse oximeters generally use established physical principles (Beer-Lambert law) and signal processing, rather than machine learning algorithms that require explicit training datasets in the conventional sense.

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

• Not applicable, as no training set or machine learning algorithm requiring such ground truth establishment is described for this device.

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