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The patient monitor is a portable device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial haemoglobin (SpO2), pulse rate(PR), Non-invasive measurement of blood pressure(NIBP) of adult patients in hospitals, medical facilities, and sub-acute environments. The patient monitor is intended for spot-checking and/or continuous monitoring of patients.

The proposed device, PM50 Patient Monitor, is a portable device, which is intended for measuring and/or cont pulse oxygen saturation (SpO2), pulse rate (PR), systolic pressure (SYS), diastolic pressure (DIA) and mean arterial pressure (MAP) on adult and pediatric.

Acceptance Criteria and Device Performance Study for Contec Medical Systems PM50 Patient Monitor

This report details the acceptance criteria and the study conducted to demonstrate that the Contec Medical Systems PM50 Patient Monitor meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the PM50 Patient Monitor are based on recognized international standards for SpO2 and NIBP measurement accuracy. The reported device performance is stated to meet these accuracy requirements.

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

The provided 510(k) summary does not explicitly state the specific sample sizes used for the SpO2 and NIBP clinical accuracy evaluation studies.

Data Provenance:

• Country of Origin: The clinical investigation for both SpO2 and NIBP was conducted in Qinhuangdao Maternal and Child Health Hospital, China.
• Retrospective or Prospective: The summary describes "clinical test discussion" and states that the device "was tested," implying a prospective clinical study conducted during the device development and validation phase.

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

The provided 510(k) summary does not specify the number of experts or their qualifications used to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

The provided 510(k) summary does not mention any specific adjudication method used for the test set. The clinical studies were conducted to evaluate the device's measurement accuracy against the respective standards.

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

An MRMC comparative effectiveness study was not performed as this device is a patient monitor performing physiological measurements, not an AI/imaging diagnostic device requiring human interpretation alongside an algorithm. Therefore, the effect size of human readers improving with or without AI assistance is not applicable.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, a standalone performance study was conducted. The clinical accuracy evaluations for both SpO2 and NIBP are standalone studies, assessing the device's ability to accurately measure these physiological parameters independently, without human intervention or interpretation of the device's output.

7. Type of Ground Truth Used

• SpO2: The ground truth for SpO2 was established by evaluating the device "in accordance with Annex EE of ISO 9919." Annex EE specifies a method for evaluating the accuracy of pulse oximeters, typically involving inducing a range of arterial oxygen saturations in healthy volunteers and comparing the oximeter's readings against a co-oximeter (which provides gold-standard arterial blood gas analysis for oxygen saturation). Therefore, the ground truth would be based on co-oximetry readings (reference measurements against a gold standard).
• NIBP: The ground truth for NIBP was established by evaluating the device "in accordance with AAMI Sp10." AAMI SP10 outlines requirements for automated sphygmomanometers, which typically involves comparing the device's measurements against auscultatory readings taken by trained observers using a mercury sphygmomanometer (or a validated equivalent) in a clinical setting. Therefore, the ground truth would be based on trained observer auscultatory measurements (reference measurements against a gold standard).

8. Sample Size for the Training Set

The provided 510(k) summary does not provide information regarding a separate training set or its sample size. For patient monitors like the PM50, the device's core algorithms for SpO2 and NIBP measurement are typically developed and validated against established physiological principles and data, often through extensive internal testing and calibration, rather than a distinct "training set" in the context of machine learning. The clinical studies described are for validation of the finalized device.

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

As noted above, the 510(k) summary does not describe a "training set" in the context of the PM50's development and validation. The ground truth for internal development and calibration would typically be established through controlled experiments using reference devices (e.g., co-oximeters, calibrated pressure transducers) and simulated physiological signals within laboratory settings, based on the principles outlined in the relevant ISO and AAMI standards. The clinical studies documented here are for proving the finalized device's performance against these standards.

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