(167 days)
The indications for use of the BeneVision Central 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 Bene Vision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities 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 BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors; The Bene Vision Central Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors.
The telemetry monitoring systems are designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The BeneVision Central Monitoring System supports Telemetry Systems: TMS-6016, Telepack-608, TMS60, TM80, and TM70.
- The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data.
- The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data.
- The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.
- The TM80/TM70 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can configure and display the physiological parameters from the TM80/TM70.
The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.
The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities 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 BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors. The BeneVision Central Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors or the TM80/TM70 Telemetry Monitors.
The BeneVision Central Monitoring System consists of the following components:
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- CentralStation
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- ViewStation
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- WorkStation
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- CMS Viewer
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- Telemetry Systems (TMS 6016, Telepak-608, TMS60, TM80, TM70)
The TMS 6016, Telepak-608, TMS60 telemetry monitoring systems 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 TM80 telemetry monitor uses the Wireless WIFI connection to transmit data to the CentralStation for display, storage, and printing.
The TM70 telemetry monitor operates in the 608M or the 1.4G WMTS frequency range within a defined coverage area, and transmits data to the CentralStation for display, storage, and printing.
The provided document is a 510(k) premarket notification for the BeneVision Central Monitoring System. It describes the device, its intended use, and comparisons to predicate devices, along with testing undertaken to demonstrate substantial equivalence. However, it does not explicitly define "acceptance criteria" in the format of a table with quantitative metrics for device performance (e.g., sensitivity, specificity, accuracy for an AI/algorithm). Instead, it explains that the modifications to the device (primarily updated host computers, increased connection/monitor support, and changes to telemetry modules and their wireless components) were assessed through functional and system-level testing to ensure they continue to meet specifications and have equivalent performance to the predicate devices.
The document is a regulatory submission for a medical device that monitors physiological data, not an AI/algorithm for diagnostic purposes, which typically involves sensitivity, specificity, or ROC curve analysis. The device's "performance" here relates to its ability to accurately acquire, display, store, print, and transfer physiological data, and its wireless connectivity capabilities, rather than a diagnostic accuracy measure that would be subject to stringent acceptance criteria for an AI model.
Therefore, many of the specific questions regarding AI/algorithm performance metrics, sample sizes for test sets, expert ground truth establishment, MRMC studies, and training set details are not directly applicable to this type of device submission as described in the provided text.
Based on the content, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a table of quantitative acceptance criteria for "device performance" in the way one would expect for an AI algorithm (e.g., a specific sensitivity threshold). Instead, the acceptance criteria are implicitly tied to the device's ability to maintain its intended functions and specifications when new components or features are introduced, demonstrating "substantial equivalence" to predicate devices. The reported performance is the successful completion of various tests and compliance with relevant standards.
| Acceptance Criterion (Implicit) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Functional Equivalence: Device continues to perform its stated indications for use (real-time viewing, storage, printing, configuration, data transfer) as effectively as the predicate. | Functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate. Specifically, with increased WorkStation/ViewStation connections (32 vs 16) and monitor support (32 vs 24), and extended NIBP/event review (3000 vs 1000 measurements/events), the changes were considered to "not raise different questions of safety and effectiveness." |
| Wireless Module Performance: New WiFi (TM80) and WMTS (TM70) modules perform communication functions (data rate, frequency, security) comparably to previous/predicate equivalents. | TM80 (new WIFI module): Passed FCC certification. "These differences do not raise different questions of safety and effectiveness, and testing demonstrates that the new WIFI module complies with relevant safety standards and has equivalent performance." |
| TM70 (WMTS module): Passed FCC certification. "These differences do not raise different questions of safety and effectiveness, and testing demonstrates that the new wireless modification comply with relevant safety standards and have equivalent performance." Wireless functionality testing was conducted to ensure performance meets specifications and is equivalent. | |
| Pace Detection Performance: The new software pace detection in TM80/TM70 performs equivalently to the previous hardware-based detection. | "The pace detection specifications have not been changed." "Testing demonstrates that the software pace detection modification comply with relevant safety standards and have equivalent performance." EMC (IEC 60601-1-2) and performance (IEC 60601-2-27) testing conducted. |
| Electromagnetic Compatibility (EMC): Device complies with EMC standards. | Assessed for conformity with IEC 60601-1-2:2014 and found to comply. Specifically, wireless coexistence testing (AAMI TIR 69, ANSI C63.27) and RFID interaction testing (AIM Standard 7351731) were performed for TM70 and TM80. |
| Electrical Safety: Device complies with electrical safety standards. | Assessed for conformity with relevant standards (e.g., ANSI/AAMI ES60601-1:2005) and found to comply. UL 60950-1 testing for AP70, SYNC70, AC70 (TM70 components). |
| Software Integrity: Software changes are verified and validated. | Software verification and validation testing was conducted and documentation provided as recommended by FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." |
| Performance Testing: Device meets specifications as demonstrated by bench testing. | Bench testing conducted per IEC 60601-2-27:2011 to validate performance. Results show the subject device meets specifications and is substantially equivalent. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified quantitatively. The document refers generally to "functional and system level testing," "bench testing," and "wireless functionality testing." For wireless coexistence, it mentions testing was performed for "up to 16 wireless medical devices... within a single AP" for TM80, and "up to 14 wireless medical devices per single AP for 608 MHz and 16 wireless medical devices per single AP for 1.4 GHz" for TM70. For wireless networking stability, it mentions "Each of the TM70 roam 30 times, at least 3 TM70s roam at the same time." These are details about the test conditions (number of devices tested simultaneously or repetitively) rather than a statistical "sample size" of patient data for algorithm performance.
- Data Provenance: Not applicable in the context of physiological data for an AI model. The testing is primarily bench-top (in vitro) and system-level, concerned with internal device performance and wireless communication, not analysis of patient data by an algorithm to produce a clinical output. The device itself collects patient data, but the testing described here focuses on the device's functional integrity.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. This submission is for a central monitoring system and telemetry modules, not a device that relies on expert interpretation to establish a "ground truth" for an AI algorithm's diagnostic output. The "ground truth" for the device's performance would be engineering specifications and standards compliance, verified through bench testing and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be disagreement in ground truth labeling for AI model training or testing. This device's testing relates to hardware and software functionality and compliance with engineering standards.
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. This is not an AI-assisted diagnostic device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The "BeneVision Central Monitoring System" is a system for displaying and managing physiological data, not a standalone AI algorithm. It's a medical device system, where the listed software functions for pace detection or arrhythmia analysis are integral parts of the physiological monitoring, not separate AI algorithms in the sense of a standalone diagnostic tool. The document states "No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors." This implies the system primarily relays and displays data without independent algorithmic analysis beyond what the individual monitors (e.g., TMS60, TM70, TM80) might perform for parameters like arrhythmia or ST-segment analysis. The "software pace detection" mentioned is an update to how the hardware detects pacemakers, not an AI diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is not derived from clinical expert consensus or pathology. Instead, it is based on:
- Engineering specifications and design requirements: The device's components and system are tested against predefined performance parameters (e.g., signal accuracy, wireless range, data integrity, latency, alarm thresholds).
- Industry and regulatory standards: Compliance with consensus standards such as IEC 60601-1-2 (EMC), IEC 60601-2-27 (ECG monitoring), AAMI TIR 69 (wireless coexistence), and FCC certifications (wireless performance).
- Predicate device equivalence: Demonstrating that the modified device performs "equivalently" to previously cleared, substantially equivalent devices.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a "training set" in the common sense (i.e., for a deep learning model). The software is developed using traditional software engineering processes (V&V testing).
9. How the ground truth for the training set was established:
Not applicable. As there's no stated AI/ML training set, the concept of establishing ground truth for it doesn't apply to this submission.
§ 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).