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The indications for use of the BeneVision Central Monitoring System include:

• Real time viewing of patient clinical data and alarms from compatible physiological monitors. Viewing of non-real time patient clinical data of compatible anesthesia devices (i.e. not indicated for real-time monitoring of clinical data of compatible anesthesia devices).

• Storage and Historical review of patient clinical data and alarms from compatible physiological monitor, and anesthesia devices.

• Printing patient data from compatible physiological monitor, and anesthesia devices.

• Configuration of local settings as well as synchronizing settings across the network to remote compatible physiological monitors.

• Transfer of patient clinical data and settings between several CentralStations.

• Provides a Resting 12 Lead interpretation of previously stored data.

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, anesthesia systems and will display, store, print, and transfer information received from the compatible monitors, anesthesia systems.

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 config 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 (CMS) is a networked patient monitoring system intended for use in healthcare settings by, or under the direction of, a physician to provide clinicians remote patient monitoring. The target patient population is adult patients and pediatrics.

When connected to a compatible anesthesia device, BeneVision CMS can display the parameters, waveforms and alarms of the anesthesia device. The device does not contain bi-directional capabilities for the compatible anesthesia devices.

The BeneVision CMS includes the AlarmGUARD application. AlarmGUARD supports delivering notifications of physiological and technical alarms to clinical professionals' mobile devices. AlarmGUARD is not intended for real time monitoring of patients and is not intended to act as a primary source for alarms.

It appears the provided FDA 510(k) clearance letter and summary for the BeneVision Central Monitoring System (K242728) does not contain specific acceptance criteria, test results (like sensitivity/specificity, accuracy metrics), or detailed study methodologies that directly address how the device's performance meets quantitative acceptance criteria for its intended functions.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K220058) through:

• Comparison of Indications for Use: Showing minor differences (expanded compatibility to include anesthesia systems, but not for real-time monitoring).
• Technological Comparisons: Highlighting changes in operating systems, host configurations, and the addition of features like Multi-Patient Viewer separation and AlarmGUARD support.
• Performance Data Section: This section lists the types of testing conducted but does not provide the results of those tests or specific acceptance criteria met by those results. It merely states that "Software verification and validation testing was conducted" and "Verification of the BeneVision Central Monitoring System was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product."

Therefore, based solely on the provided text, I cannot extract the detailed information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document confirms the following regarding the study:

• Study Type: Software verification and validation testing, along with specific bench testing.
• Clinical Data/Animal Testing: Not applicable/not required for this submission to establish substantial equivalence. This suggests the clearance relies on non-clinical data and comparison to the predicate.
• Ground Truth: The document implies that the ground truth for software verification and validation would be the design specifications and expected behavior of the system, rather than clinical outcomes or expert consensus on a diagnostic task. For the "Waveform Display Accuracy from compatible Anesthesia Machine," the ground truth would likely be the direct output from the anesthesia machine itself.

What is present in the document that somewhat relates to your request:

• "Bench Testing" section (Page 19): This lists specific tests performed:
  • AlarmGUARD IEC 60601-2-27
  • AlarmGUARD IEC 60601-1-8
  • AlarmGUARD Human Factors
  • Waveform Display Accuracy from compatible Anesthesia Machine

To fulfill your request as best as possible with the given information, I will have to state that many details are explicitly absent from this public 510(k) summary.

Here's a structured response based on the provided document, indicating what information is present and what is absent:

Device Acceptance Criteria and Performance Study Summary (K242728)

Based on the provided FDA 510(k) Clearance Letter and Summary, detailed quantitative acceptance criteria and specific performance metrics (like accuracy, sensitivity, specificity) for the BeneVision Central Monitoring System are not explicitly presented. The submission primarily relies on demonstrating substantial equivalence to a predicate device (K220058) through verification and validation of software and specific bench testing.

The document states that "Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance 'Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff'." It also mentions that "Verification of the BeneVision Central Monitoring System was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified in the provided document for any of the listed tests (AlarmGUARD, Waveform Display Accuracy, general software V&V).
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given that no clinical data was used or required, the "data" would be synthetic, simulated, or derived from direct device connections during bench testing.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable / Not specified. The document does not describe the use of human experts to establish ground truth for a diagnostic task or for the performance evaluation of this central monitoring system. The focus is on software function and electro-mechanical performance validation against design specifications and international standards.

4. Adjudication Method for the Test Set

• Not applicable / Not specified. No adjudication method is mentioned as human reader input for a test set is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. The document explicitly states that "Clinical testing is not required to establish substantial equivalence to the predicate device" and does not mention any MRMC study. This device is a central monitoring system displaying physiological data, not an AI diagnostic tool requiring MRMC studies for improved human reader performance.

6. Standalone Performance (Algorithm Only)

• The "performance data" section lists "Software Verification and Validation Testing" and "Bench Testing" (including "Waveform Display Accuracy from compatible Anesthesia Machine"). These tests conceptually represent 'standalone' performance in that they evaluate the device's technical functions directly. However, no specific quantitative standalone performance metrics (e.g., classification accuracy, sensitivity, specificity for any internal algorithms) are provided in this summary beyond the statement that v&v was conducted to ensure the product "works as designed."

7. Type of Ground Truth Used

• The ground truth for the device's performance appears to be:
  • Design Specifications: For general software verification and validation.
  • External Reference Standards/Simulators: For tests like "Waveform Display Accuracy" (e.g., comparing the displayed waveform to the known, true signal generated by a simulator or the anesthesia machine itself).
  • International Standards: For AlarmGUARD functionality (e.g., IEC 60601-2-27, IEC 60601-1-8).

8. The Sample Size for the Training Set

• Not applicable / Not specified. This document describes a traditional medical device (patient monitoring system software) rather than a machine learning/AI device that typically requires a distinct "training set." Therefore, no training set size is mentioned.

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

• Not applicable / Not specified. As no training set for an AI/ML model is indicated, there is no mention of how its ground truth would be established.

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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
• Provides a Resting 12 Lead interpretation of previously stored data

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 (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.

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 config 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 (CMS) is a networked patient monitoring system intended for use in healthcare settings by, or under the direction of, a physician to provide clinicians remote patient monitoring. The target patient population is adult patients and pediatrics.

The provided text is a 510(k) premarket notification summary for the BeneVision Central Monitoring System. It details the device, its intended use, comparison to predicate devices, and various testing performed to demonstrate substantial equivalence.

However, the document does not contain information about an AI/algorithm where acceptance criteria and specific performance metrics (like sensitivity, specificity, or AUC) or information related to multi-reader multi-case (MRMC) comparative effectiveness studies would typically be found. The changes describe modifications to the software for an existing central monitoring system, primarily related to operating system compatibility, supported monitors, and the addition of a "Resting 12 Lead interpretation of previously stored data" feature.

The document discusses "Software Verification and Validation Testing" and "Bench Testing" to ensure the device meets its specifications, but these tests are for the overall system's functionality and accuracy, not for an AI component that would require the level of detail requested in the prompt.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance for an AI model, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device, as this information is not present in the provided text.

The information that is available in the document regarding testing is general:

• Software Verification and Validation Testing: Conducted "as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."" This ensures the product "works as designed" and validates its "design and performance."
• Bench Testing: Conducted "functional and system level testing to validate the performance of the devices." The results "show that the subject device meets its accuracy specification, and is substantially equivalent to the predicate device."
• Consensus Standards: The device meets relevant consensus standards, specifically mentioning IEC 60601-2-25:2011 for electrocardiographs.

The document explicitly states:

• Animal Testing: "Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device."
• Clinical Data: "Not applicable. Clinical testing is not required to establish substantial equivalence to the predicate device."

Without an AI/ML component described with specific performance criteria and a study demonstrating its meeting those criteria, the detailed information requested in the prompt cannot be extracted from this document.

Ask a specific question about this device

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:

• 1. CentralStation
• 2. ViewStation
• 3. WorkStation
• 4. CMS Viewer
• 5. 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.

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.

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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 healthes 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 Bene Vision 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, and TM80.

· 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 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 config and display the physiological parameters from the TM80.

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.

The BeneVision Central Monitoring System consists of the following components:

• 1. CentralStation
• 2. ViewStation
• 3. WorkStation
• 4. CMSViewer
• 5. Telemetry Systems (TMS 6016. Telepak-608. TMS60. TM80)

Here's an analysis of the acceptance criteria and study information provided, structured as requested.

Acceptance Criteria and Device Performance

The provided document describes modifications to an existing device (BeneVision Central Monitoring System) and aims to demonstrate substantial equivalence to a predicate device (K162607). The document presents a comparison of technological characteristics as the primary proof of meeting acceptance criteria, rather than explicit quantitative acceptance metrics for performance. The "Performance Data" section details types of testing conducted to ensure the device performs as designed and meets relevant standards.

Table of Acceptance Criteria and Reported Device Performance

Since explicit quantitative acceptance criteria with specific threshold values for "device performance" in terms of accuracy, sensitivity, specificity, etc., are not directly stated in the tables for the subject device (as would be common for diagnostic AI), the "Acceptance Criteria" column will reflect the stated functionalities or characteristics of the subject device, and "Reported Device Performance" will indicate if the device meets these in comparison to the predicate. The overall "acceptance criterion" is essentially demonstrating that the changes do not raise new questions of safety and effectiveness and that the device continues to meet relevant standards.

Study Information

The document describes software verification and validation, electromagnetic compatibility, electrical safety, and bench testing to demonstrate substantial equivalence. It is important to note that this is a 510(k) Premarket Notification for a modified device, not a de novo submission or a claim of new clinical efficacy. Therefore, the "studies" outlined are primarily focused on engineering and performance verification of the changes.

1. Sample size used for the test set and the data provenance:

   • The document does not specify sample sizes for test sets in terms of patient data or clinical cases. The testing appears to be focused on functional and system-level verification, as well as conformance to technical standards.
   • Data provenance (e.g., country of origin, retrospective/prospective) is not provided as the focus is on engineering verification.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not applicable or provided. The document focuses on demonstrating substantial equivalence through technical comparisons and compliance with relevant standards, rather than establishing a clinical "ground truth" derived from expert interpretation of medical images or patient data in a comparative clinical study.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This information is not applicable or provided. Adjudication methods are typically used in clinical studies involving multiple readers and ground truth evaluation, which is not the focus of this 510(k) summary.

4. 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:

   • No MRMC comparative effectiveness study was done or reported. The device (BeneVision Central Monitoring System) is a patient monitoring system which, based on the description, primarily displays, stores, prints, and transfers physiological data and alarms. While it performs some analysis (e.g., arrhythmia, ST segment), it's not described as an AI-powered diagnostic tool requiring a human-in-the-loop performance study in the way an AI-CADx system would. The changes described are enhancements to the monitoring system's capabilities and compliance with updated standards.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The document implies that elements like the "Mindray ECG algorithm modifications" and "Intelligent arrhythmia alarm" have undergone verification to ensure they perform according to specifications (e.g., "enhanced performance," "same methods employed by the Central Station"). However, a formal "standalone performance study" with typical metrics like sensitivity, specificity, and F1 score against a reference standard on a clinical dataset is not explicitly detailed or quantified in the provided text. The verification likely involved testing against known waveforms and simulated conditions to confirm algorithm accuracy according to engineering specifications.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Given the nature of the device (a core patient monitoring system), the "ground truth" for its functional performance would typically involve:
     • Reference signals/simulators: For verifying ECG, SpO2, NIBP, RESP parameters against known inputs.
     • Standardized test conditions: For EMC, electrical safety, and alarm system performance.
     • Software testing (unit, integration, system): Using expected outputs for given inputs to verify logic and calculations.
     • Predicate device comparison: The predicate device itself acts as a reference for expected performance in many aspects of substantial equivalence.
   • Specific details about ground truth for individual algorithms (e.g., how the "enhanced performance" of the ECG algorithm was measured against a reference standard) are not provided beyond the general statement of "functional and system level testing."

7. The sample size for the training set:

   • The document does not mention a training set, as these are engineering changes and updates to a non-AI patient monitoring system, not a de novo AI/ML algorithm requiring a distinct training phase.

8. How the ground truth for the training set was established:

   • This section is not applicable, as no training set is mentioned.

Ask a specific question about this device

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 healthes 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 Bene Vision 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, and TM80.

• 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 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 reviewed locally on the display of the monitor. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TM80.

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.

The BeneVision Central Monitoring System consists of the following components:

• 1. CentralStation
• 2. ViewStation
• 3. WorkStation
• 4. CMSViewer
• 5. Telemetry Systems (TMS 6016, Telepak-608, TMS60,TM80)

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 processing, display, and alarm.

This document is a 510(k) Pre-market Notification for the BeneVision Central Monitoring System. It's a submission to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This type of document generally focuses on comparing the new device's features and performance to an existing one, rather than presenting a standalone study showing general device performance against predefined acceptance criteria in the way a clinical trial for a new drug or diagnostic might.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format you requested. Instead, it relies on comparison to a predicate device and adherence to recognized standards. The "Performance Data" section states that Mindray "conducted functional and system level testing on the subject device. 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."

This implies that the "acceptance criteria" are essentially to meet the performance specifications of the predicate device and relevant consensus standards. The performance is reported as meeting these specifications and being equivalent.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for any test sets, nor does it provide details on data provenance (country of origin, retrospective/prospective). The testing mentioned is "functional and system level testing," which typically involves engineering and verification testing rather than testing on patient data in a clinical setting.

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)

This information is not provided. Given the nature of the device (a central monitoring system that displays, stores, and transfers data from other physiological monitors, rather than performing primary diagnostic analysis), the "ground truth" would likely be established through technical validation against known input signals or simulated data according to engineering specifications, rather than expert clinical consensus on actual patient cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/not provided. Adjudication methods are typically relevant for studies involving human interpretation or labeling of complex data (e.g., medical images). The testing described appears to be technical validation.

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

An MRMC study was not conducted. This device is a central monitoring system, not an AI-powered diagnostic tool for interpretation by human readers. It primarily displays, stores, and transfers data. There is no mention of AI assistance in the document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable in the sense of a diagnostic algorithm. The "algorithm" here refers to the system's ability to accurately process and display physiological data. The performance section describes "functional and system level testing" and "Wireless functionality testing," which evaluate the system's technical operation in a standalone manner (i.e., the system's ability to perform its stated functions without direct human intervention in the data processing). The device description explicitly states: "No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors." This suggests it acts as a relay and display, not an analytical engine for raw data interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document doesn't explicitly state the type of "ground truth." However, for a device like a central monitoring system, the ground truth for testing would primarily involve:

• Known input signals: Generating physiological signals (ECG, SpO2, NIBP, Respiration) with known values and waveforms to verify accurate reception, display, and storage by the BeneVision system.
• System specifications: Verifying that the system meets its own design specifications for data transfer, alarm functionality, display accuracy, and configuration synchronization.
• Compliance with standards: Demonstrating adherence to relevant consensus standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, etc.) which often involve specific test methodologies and criteria.

8. The sample size for the training set

The document does not describe a "training set." This type of system (a central monitoring system) does not typically involve machine learning or AI models that require training sets in the conventional sense. Its functionality is based on established engineering principles for data acquisition, transfer, and display.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set.

Summary of the study and acceptance criteria based on the provided document:

The submission for the BeneVision Central Monitoring System is a 510(k) Pre-market Notification, which primarily aims to demonstrate substantial equivalence to a predicate device (Hypervisor IX Monitoring System, K150632).

Acceptance Criteria (Implied, not explicitly stated numerically):

The implied acceptance criteria are that the BeneVision Central Monitoring System:

• Performs its stated functions (real-time viewing, storage, historical review, printing, configuration synchronization, data transfer) equivalently to or better than the predicate device.
• Meets its own design specifications for functional and system level performance.
• Complies with relevant national and international consensus standards for medical electrical equipment and patient monitoring.
• The differences from the predicate (e.g., added display sizes, increased monitor capacity, added TM80 telemetry support with NIBP/Resp/WiFi/6-lead ECG, increased data review storage) do not raise new questions of safety or effectiveness.

Reported Device Performance:

The document states:

• "Mindray conducted functional and system level testing on the subject device. 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."
• "Mindray conducted Wireless functionality testing to ensure the performance of the BeneVision Central Monitoring System meets wireless specifications and is equivalent to the predicate device."
• "Mindray has conducted testing to ensure the subject device meets relevant consensus standards." (A list of specific standards is provided).

In essence, the "study" described is a series of engineering verification and validation tests (functional, system level, wireless functionality) performed by the manufacturer to demonstrate that the device meets its own specifications and relevant standards, and that its performance is equivalent to the legally marketed predicate device. It is not a clinical trial or a study involving human-in-the-loop performance measurement or AI comparative effectiveness.

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