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The device is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to monitor ECG. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2) noninvasive blood pressure (NIBP) and respiratory rate. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also condition and transmit physiological signals via radio frequency. Waveforms, numeric data, trendgraphs, and vital signs lists can be recorded manually or automatically on the optional recorder unit. Waveforms and parameter data from the monitor can be sent to a Cardiac Telemetry System, or to a Central Monitor via a Multiple Patient Receiver and transmitter. The device will be available for use by medical personnel on all patient populations.

The device is a multi-parameter monitor consisting of a color LCD screen to display waveforms and numerics of monitored parameters. Options include a builtin thermal array recorder. The device is software driven. Both the device and the predicate have the same intended use to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to monitor the electrocardiogram. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), and respiratory rate. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also condition and transmit physiological signals via radio frequency. This device will be available for use by medical personnel on all patient populations.

The Nihon Kohden OPV Series Bedside Monitor is a multi-parameter monitor intended to display and record physiological data for cardiac and vital signs monitoring within a medical facility. The device monitors ECG, heart rate, pulse rate, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), and respiratory rate. It can generate alarms and transmit physiological signals.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The provided document does not contain a specific table detailing acceptance criteria for each physiological parameter (ECG, HR, SpO2, NIBP, Respiration Rate) and the device's reported performance against those criteria. Instead, it focuses on compliance with general medical device standards.

   Therefore, a table cannot be constructed from the given text.

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

   The document does not explicitly state a sample size for a "test set" in the context of assessing individual physiological parameter accuracy with clinical data.

   The performance testing mentioned refers to:

   • Compliance with IEC 60601-1 subclause 56.3(c) implemented by 21 CFR Part 898: This pertains to Electrode Lead Wires and Patient Cables.
   • Compliance with voluntary industrial standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-27, IEC 60601-2-30. These are general electrical safety and performance standards for medical electrical equipment.
   • Environmental testing: Temperature/humidity stress, electromagnetic interference/compatibility.
   • Safety standards testing and performance testing procedures: These were based on "product specifications and applicable standards."

   The text indicates that "The completed testing showed that the device met its product specifications and verified conformance to safety, reliability, and applicable standards." However, it does not specify the type of data (retrospective/prospective, country of origin) used for these "performance testing procedures" in relation to clinical accuracy of the monitored parameters. It seems to refer more to technical and safety performance rather than clinical validation of parameters against a gold standard.

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

   The document does not describe the use of human experts to establish ground truth for a clinical test set for the physiological parameters. The performance testing seems to relate to technical standards and specifications rather than a multi-expert clinical review of monitoring accuracy.

4. Adjudication Method for the Test Set:

   Since the document does not describe a process involving human expert review for establishing ground truth on a clinical test set, there is no mention of an adjudication method (e.g., 2+1, 3+1).

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

   No mention is made of an MRMC comparative effectiveness study, or how human readers (medical personnel) improve with or without AI assistance. The device in question is a bedside patient monitor, not an AI-powered diagnostic tool requiring human interpretation improvement studies.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   The document describes the device's inherent function as a standalone monitor. The performance testing mentioned ("met its product specifications and verified conformance to safety, reliability, and applicable standards") implicitly refers to the device's standalone performance in fulfilling its monitoring role. However, it doesn't provide specific standalone performance metrics (e.g., accuracy, sensitivity, specificity) for each physiological parameter against a clinical gold standard. The device's primary function is data acquisition and display, rather than an "algorithm" with a specific diagnostic output separate from human interpretation.

7. Type of Ground Truth Used:

   The "ground truth" implicitly referred to in the document's performance testing section appears to be product specifications and applicable standards (e.g., IEC standards for electrical safety and performance, FDA performance standards for electrode lead wires). There is no explicit mention of pathology, outcomes data, or expert consensus being used as ground truth for the accuracy of displayed physiological parameters.

8. Sample Size for the Training Set:

   The document pertains to a hardware device (bedside monitor) with software control for parameter display. It does not describe a machine learning or artificial intelligence algorithm that would require a "training set" in the conventional sense. The development likely involved engineering design, calibration, and verification against known inputs and technical specifications, rather than data-driven machine learning training.

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

   As there is no mention of a traditional "training set" for a machine learning algorithm, the concept of establishing ground truth for such a set is not applicable here. The device's functionality is based on established physiological measurement principles and engineering design, with verification against technical standards.

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