(254 days)
The Central Monitoring System is intended to conduct centralized monitoring of adult, pediatric and neonatal vital sign information from multiple monitors in hospitals or medical institutions, the monitoring parameters include ECG, NIBP, SpO2, PR, RESP, IBP, TEMP, CO2 and AG. It is not intended for home use.
Central Monitoring System is a kind of medical information system widely applied in clinical monitoring, whose operation requires specific hardware environment such as a PC platform, the PC and Operation System is dedicated. Depending on the specific hardware platform, the Central Monitor System constitutes a monitoring network system together with software, the Operation System and work together with bedside monitors. It can collect, and export the monitoring information of the patient transferred via network from the bedside monitor. It can also display and export the integrated information from bedside monitors so as to free-up doctors from clinical monitoring work and create centralized monitoring management.
The HYPERVISOR VI Central Monitoring System is a medical information system. This System includes a high-performance PC hardware system, the application software and Windows operation system (Windows XP). Through applying Mindray specified protocol, the Central Monitoring System obtains physiological information from cleared bedside monitors manufactured by Mindray, includes: PM-8000 Express, PM-9000 Express and VS-800.
The Central Monitoring System can maximally support the simultaneous networking of 32 bedside monitors. Also, TCP/IP protocol is applied to ensure reliable transmission of network data.
The Central Monitoring System offers centralized display of physiological information of many patients who are currently monitored simultaneously. The software can support two displays simultaneously, and can display information from up to 16 bedside monitors on a display and 32 bedside monitors on two displays simultaneously. And if any of the bedside monitors gives off alarm, prompt information will be immediately displayed by means of audible /words for medical personnel's attention.
The physiological waveforms displayed on the central monitoring system include to: ECG waveforms, RESP waveforms, CO2 waveforms, PLETH waveforms, IBP waveforms, and AG waveforms. The physiological parameters displayed on the central monitoring system include: HR, RR, SpO2, PR, SYS, DIA, MEAN, TEMP, CO2, AwRR.
Central Monitoring System makes an announcement for the physiological parameters based on the bedside monitor. The software also performs notification directly for alarms from the bedside monitor and triggers technical alarms for the error and failure of itself. Moreover database technology is applied to store these alarm events for the convenience of doctor's review and analysis.
The provided text describes the HYPERVISOR VI Central Monitoring System and aims to demonstrate its substantial equivalence to a legally marketed predicate device. However, it does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and a detailed study.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the conclusion drawn from testing and validation demonstrates the device is "as safe, as effective, and performs as well as the legally marketed predicate device, the M3150 Information Center (K#011093, by Agilent Co., Ltd)."
This implies that the acceptance criterion was substantial equivalence to the predicate device. However, the document does not specify quantifiable performance metrics or a detailed table of acceptance criteria used in the testing and validation, nor does it present specific performance data for the HYPERVISOR VI Central Monitoring System.
Missing Information: Specific numerical acceptance criteria (e.g., accuracy percentages, latency thresholds, alarm reliability rates) and the corresponding reported performance values from the study are not provided in this summary.
2. Sample size used for the test set and the data provenance:
Missing Information: The document does not provide any information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Missing Information: There is no mention of experts being used to establish a ground truth for a test set, nor their number or qualifications. This type of device (a central monitoring system displaying vital signs) would likely rely on direct comparison of displayed values to those from source monitors rather than expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Missing Information: No information about an adjudication method is provided.
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/Missing Information: This device is a central monitoring system for displaying vital signs, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study would not be relevant in this context, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device described is a "Central Monitoring System" which "collects, and exports the monitoring information of the patient transferred via network from the bedside monitor." It "offers centralized display of physiological information" and "makes an announcement for the physiological parameters based on the bedside monitor." This implies it operates in a standalone (algorithm only) capacity in terms of data collection, processing, and display, without a human-in-the-loop directly influencing its core function of data presentation from bedside monitors.
The "study" referenced in the "Conclusion" section ("The conclusions drawn from testing and validation...") would therefore refer to the performance of the system itself in accurately collecting, transmitting, displaying, and alarming based on the data received from the bedside monitors.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Given the nature of the device as a central monitoring system for vital signs, the ground truth would most likely be established by direct comparison to the data generated by the source bedside monitors themselves. For example, comparing the heart rate displayed on the central monitor to the heart rate transmitted by the bedside monitor.
Missing Information: The document does not explicitly state the type of ground truth used.
8. The sample size for the training set:
Not Applicable/Missing Information: This device is a data display and management system, not a machine learning model that requires a "training set" in the traditional sense. It processes and displays existing physiological data.
9. How the ground truth for the training set was established:
Not Applicable/Missing Information: As above, the concept of a "training set" and its associated ground truth establishment is not relevant for this type of device according to the provided text.
Summary of available information regarding the "study" findings:
- Study Goal: To demonstrate substantial equivalence of the HYPERVISOR VI Central Monitoring System to the Agilent Technologies Information Center (AIC) Software (K011093).
- Methodology Hint: "Testing and validation" were performed.
- Outcome/Conclusion: The device is "as safe, as effective, and performs as well as the legally marketed predicate device."
- Key Differences noted (suggesting aspects compared):
- M3150 (predicate) offers ST segment and arrhythmia analysis; HYPERVISOR VI does not.
- M3150 offers Telemetry and wireless monitoring; HYPERVISOR VI does not.
- PC requirements differ (OS, CPU).
- Maximum number of connecting bedside monitors differs (HYPERVISOR VI: 32; M3150: 16).
- Missing Details: Specific tests conducted, test protocols, numerical results, statistical analyses, or the detailed parameters measured during the "testing and validation" are not included in this 510(k) summary. The summary focuses on comparing technical specifications and overall intended use rather than detailed performance study results.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.