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The Bionet BM3/BM3 Plus Patient Monitor is intended for use by trained healthcare personnel to diagnose and monitor multiple physiological parameters of human patients. It can be used on patients from adults to neonates. The device is designed as a bedside and portable monitor that can operate in all professional medical facilities.

Physiological data include but are not restricted to: end-tidal CO2, electrocardiogram, pulse oximetry, pulse rate, noninvasive blood pressure, temperature, and respiration. The data output is displayed on an LCD screen and/or through a built-in printer as numerical data or in waveform. The device may sound an alarm when a monitored parameter falls outside preset upper or lower limits.

The device is not intended for use as an apnea monitor, and it is not intended for use during MRI or CT scans.

The Bionet BM3/BM3 Plus Patient Monitor (BM3/BM3 Plus) is a multifunctional device that monitors vital signs of human patients from neonates to adults. Parameters monitored by BM3/BM3 Plus include end-tidal CO2 (EtCO2). electrocardiogram (ECG), pulse oximetry (SpOz), pulse rate, noninvasive blood pressure (NIBP), temperature, and respiration, Data output is displayed in numeric and/or wave form(s) on a color LCD screen. Selected parameters and waves can also be shown in print via a built-in 58 mm thermal printer. The device may sound an alarm when a monitored parameter falls outside preset upper or lower limits.

BM3/BM3 Plus is compact and can be used in either stationary mode in all professional medical facilities or on the move in medical transport mode. Its energy source can come from AC input or lithium-ion battery. BM3/BM3 Plus LAN connection capability enables the device to be built into a monitoring system, so that one person can monitor several patients at a time.

The provided text, K132033, describes a 510(k) premarket notification for the Bionet BM3/BM3 Plus Patient Monitor. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a de novo study with specific acceptance criteria and performance data for a novel device. Therefore, much of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, and comparative effectiveness studies is not detailed in this submission.

Here's a breakdown of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission does not provide specific acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy percentage) that a novel device would need to meet. Instead, the "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to predicate devices by:

• Having the same intended use.
• Having similar technological characteristics that do not raise new questions of safety or effectiveness.
• Conforming to relevant safety standards.

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

The document explicitly states: "Clinical test is not applicable to BM3/BM3 Plus."

This indicates that a specific clinical test set for evaluating accuracy or performance in human patients with a defined sample size was not conducted or submitted as part of this 510(k). The evaluation relied on comparisons to existing cleared devices and standards compliance.

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

Since no clinical test set was used, there were no experts involved in establishing ground truth for such a set. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices and the technical standards themselves.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was used.

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

No, an MRMC comparative effectiveness study was not done. The submission relies on demonstrating substantial equivalence to predicate devices, not on comparing the new device's performance against human readers or other AI systems.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable in the context of this general patient monitor. The EtCO2 functionality itself is a measurement algorithm, but the submission does not detail its standalone performance as a novel algorithm, rather its equivalence to existing cleared technologies. The device is intended for use by "trained healthcare personnel," implying human-in-the-loop operation for interpretation and diagnosis.

7. The Type of Ground Truth Used:

For the EtCO2 functionality, the "ground truth" for demonstrating equivalence is based on the fact that both Microstream (used in Star 50N) and Sidestream/Mainstream (used in BM3/BM3 Plus) capnography technologies have been "previously cleared for the purpose of monitoring the level of carbon dioxide in exhaled breath (EtCO2) to assess a patient's ventilatory status." This refers to regulatory clearance and established scientific principles rather than a directly collected clinical ground truth for this specific device.

For the other parameters (ECG, SpO2, NIBP, temperature, respiration), the ground truth is implicitly the established performance of the legally marketed predicate Bionet BM3 Plus Patient Monitor (K082008), to which the new device is identical for these functions.

8. The Sample Size for the Training Set:

Not applicable. The submission refers to a medical device (patient monitor) which utilizes sensor technology and embedded software, rather than a machine learning or AI model that would typically require a training set. The "software" mentioned "monitors and displays data from vital signs sensor modules."

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

Not applicable, as there was no training set in the context of machine learning or AI.

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