(149 days)
The 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: 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 patient monitor is not intended for use as an apnea monitor. The patient monitor is not intended for use during MRI or CT scans.
Bionet BM3Plus Patient Monitor ("BM3Plus" or the "subject device") is a multifunctional device that monitors vital signs of human patients from neonates to adults. Parameters monitored by BM3Plus include electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, noninvasive blood pressure (NIBP), temperature, and respiration. Data output is displayed in numeric and/or wave form(s) on a 7-inch 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.
BM3Plus is compact and can be used in either stationary mode or on the move in all professional medical facilities. Its energy source can come from AC input or lithium-ion battery. BM3Plus' LAN connection capability enables the device to be built into a monitoring system, so that one person can monitor several patients at a time.
This document describes the Bionet BM3Plus Patient Monitor, but it explicitly states that "Clinical test is not applicable to BM3Plus."
Therefore, a study demonstrating the device meets specific acceptance criteria based on clinical performance data is not provided in this submission. The submission focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized consensus standards and a comparison of technical specifications.
Here's an analysis based on the provided text, primarily addressing why many of the requested points cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document lists several IEC and EN standards (e.g., IEC 60601-1, IEC 60601-1-2, EN 865, EN 1060-1, etc.) that the BM3Plus meets. These standards themselves contain detailed performance and safety requirements, which serve as the acceptance criteria for the device's design, electrical safety, electromagnetic compatibility, and specific parameter monitoring capabilities (e.g., ECG, NIBP, SpO2).
- Reported Device Performance: The document states that the BM3Plus "meets" these standards. However, it does not provide a table of specific numerical performance metrics (e.g., accuracy, precision, sensitivity, specificity) for each monitored parameter (ECG, SpO2, NIBP, temperature, respiration) and how they measure up against a set of clinical acceptance criteria derived from a performance study. The statement "Clinical test is not applicable to BM3Plus" means such a table based on clinical data is not included.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. Since no clinical performance study was conducted or presented, there is no test set, sample size, or data provenance from a clinical perspective. The "testing" referred to in the document pertains to adherence to recognized consensus standards, which typically involves bench testing, electrical safety testing, and EMC testing, not clinical data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. As no clinical performance study was conducted, there was no ground truth established by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No clinical test set means no adjudication method was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / Not provided. This device is a patient monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. The BM3Plus is a patient monitoring device, not a standalone algorithm. Its performance is inherent in its hardware, firmware, and sensor technology, and its "standalone" performance is measured against the technical specifications within the consensus standards it claims to meet.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided for clinical performance. For the non-clinical testing against consensus standards, the "ground truth" would be the reference measurements and specifications defined within those standards and performed by calibrated testing equipment, not clinical expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Not applicable / Not provided. Since this is not an AI/machine learning device requiring a training set, this question is not relevant.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set mentioned, this question is not relevant.
In summary of what is provided:
The submission for the Bionet BM3Plus Patient Monitor establishes its safety and effectiveness through substantial equivalence to an existing predicate device (Goldway UT4000F Patient Monitor, K021154) and by demonstrating compliance with a list of recognized consensus standards (IEC, EN, ISO). The document explicitly states that "Clinical test is not applicable to BM3Plus," meaning that the acceptance criteria are primarily met through engineering design verification and validation against these standards, rather than through a clinical performance study with human subjects or patient data.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).