(117 days)
The indications for use of the Hypervisor IX Monitoring System include:
- · Real time viewing of patient clinical data and alarms
- · Storage and Historical review of patient clinical data and alarms
- · Printing of real time and historical patient data
- · Configuration of local settings as well as synchronizing settings across the network to a remote device
- · Transfer of patient clinical data and settings between several CentralStations
The Hypervisor IX Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in a hospital or clinical environment to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wireless WiFi (WLAN), and Wireless WMTS. The Hypervisor IX Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors; The Hypervisor IX Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the Hypervisor IX Monitoring System for data received from compatible monitors.
The Hypervisor IX Monitoring System includes several Telemetry monitoring subsystems all of which operate in the 608M WMTS frequency range within a defined coverage area. All of the supported telemetry systems transmit data to the CentralStation for processing, display, and alarm.
· The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data. The CentralStation will support ECG, Heart Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS-6016.
• The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data. The Centralstation will support ECG, Heart Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the Panorama Telepack-608.
· The TMS60 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data. The physiological data can be reviewed locally on the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.
The Hypervisor IX Monitoring System is intended for use in a hospital or other clinical environment under the direct supervision of a licensed healthcare practitioner.
The Hypervisor IX Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in a hospital or clinical environment to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wired), Wireless WiFi (WLAN), and Wireless WMTS.
The Hypervisor IX Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors; The Hypervisor IX Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the Hypervisor IX Monitoring System for data received from compatible monitors.
The Hypervisor IX Monitoring System includes three telemetry monitoring systems all of which operate in the 608M WMTS frequency range within a defined coverage area. All of the supported telemetry systems transmit data to the CentralStation for processing, display, and alarm.
The Hypervisor IX Monitoring System consists the following components:
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- Central Station
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- View Station
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- Work Station
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- Telemetry Systems (TMS 6016, Telepak-608, TMS60)
Here's an analysis of the provided text regarding the acceptance criteria and study for the Hypervisor IX Monitoring System, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantifiable manner (e.g., target accuracy, sensitivity, specificity). Instead, it describes general claims of meeting specifications and equivalence to a predicate device. The performance data section focuses on types of testing performed rather than specific quantitative results against pre-defined criteria.
| Feature/Test | Acceptance Criteria (Not explicitly stated with quantifiable thresholds in the document) | Reported Device Performance |
|---|---|---|
| Functional and System Level Testing | Implied: Device meets all functional and system-level specifications. | "The testing provided an evaluation of the performance of the device relevant to each of the differences between the subject device and the predicate device. The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate." |
| Compliance with Relevant Consensus Standards | Implied: Device meets all relevant consensus standards. | "Mindray has conducted testing to ensure the subject device meets relevant consensus standards." (References "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm Guidance for Industry and FDA (10/28/2003)", "Cardiac Monitor Guidance (Including Cardiotachometer and Rate Alarm)", and "Class II Special Controls Guidance Document: Electrocardiograph Electrodes") |
| Wireless Functionality Testing | Implied: Device meets wireless specifications. | "Mindray conducted Wireless functionality testing to ensure the performance of the Hypervisor IX Monitoring System meets wireless specifications and is equivalent to the predicate device." |
| Substantial Equivalence (Overall System Performance) | Implied: Differences do not raise new questions of safety and effectiveness. | "Based on the detailed comparison of specifications for each of the modifications to the previously cleared Hypervisor Central Monitoring System, the functional and performance testing and conformance with applicable standards as well as the comparison of indications, the differences do not raise new questions of safety and effectiveness and the Hypervisor IX Monitoring System can be found substantially equivalent to the predicate device." |
| QT Monitoring | Implied: Performance comparable to cleared predicate with QT monitoring. | "Although QT monitoring was not included in the predicate Hypervisor device, it is present in the cleared Philips ST/AR ST and Arrhythmia Software (K101521), and thus does not constitute a new intended use for a patient monitoring system." |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not provide information regarding:
- The specific sample size (number of patients, records, or tests) used for performance testing (test set).
- The country of origin of the data.
- Whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on:
- The number of experts, if any, used to establish ground truth for the test set.
- The qualifications of such experts.
The testing described (functional, system-level, wireless) appears to be primarily engineering verification against specifications rather than clinical validation requiring expert ground truth on patient data. The statement regarding QT monitoring references a predicate device (Philips ST/AR ST and Arrhythmia Software K101521) for establishing the safety/effectiveness of that function, implying reliance on that previous clearance rather than new clinical ground truthing on this specific device.
4. Adjudication Method for the Test Set
The document does not provide information on any adjudication method used for the test set. Given the nature of the described testing, formal adjudication by experts is unlikely to have been part of these specific tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The document does not indicate that an MRMC comparative effectiveness study was done. This type of study is more relevant for diagnostic AI devices where human reader performance is a key metric. The Hypervisor IX Monitoring System is described as a networked patient monitoring system that displays, stores, prints, and transfers data; it explicitly states "No data processing is done by the Hypervisor IX Monitoring System for data received from compatible monitors." This implies the system's role is data management and display, not AI-driven interpretation or diagnosis that would typically warrant an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The document does not describe the device as incorporating an AI algorithm that would typically require standalone performance evaluation. The statement "No data processing is done by the Hypervisor IX Monitoring System for data received from compatible monitors" suggests its function is passive.
7. The Type of Ground Truth Used
Based on the description of testing (functional, system-level, wireless compliance, and comparison to predicate specifications), the "ground truth" for the tests performed would likely be:
- Engineering Specifications: For functional and system-level tests.
- Regulatory Standards: For compliance with consensus standards.
- Predicate Device Performance/Clearance: For demonstrating equivalence and justification for new features like QT monitoring.
There is no mention of ground truth derived from expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
The document does not mention a training set. This is consistent with the description of the device as not performing data processing or incorporating AI that would require machine learning training.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied, there is no information on how ground truth for a training set would have been established.
§ 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).