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The Accutorr 7/VS-900 Vital Signs Monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), Temperature (TEMP) and Carbon Dioxide (CO2), on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.

The monitor also provides a Modified Early Warning Score (MEWS) for clinical assessment in adult patients.

The Accutorr 7/VS-900 Vital Signs Monitor is a compact, easy-to-use vital signs monitor designed to satisfy basic monitoring needs. This patient monitor consists of a main unit, parameters measurement accessories, peripheral equipments or accessories.

This document is a 510(k) Summary for the SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Accutorr 7/VS-900 Vital Signs Monitor. It outlines the device's indications for use, description, performance data, and a comparison to predicate devices to establish substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and studies:

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

The document does not explicitly present a table of acceptance criteria. Instead, it details various performance specifications for each physiological parameter (Temperature, SpO2, Pulse Rate, NIBP) found in the "Predicate Device (K132038)" column, and states that the "Subject Devices" (Accutorr 7/VS-900) generally have the "Same" performance characteristics. For CO2 monitoring, it references the characteristics of the reference predicate (K152902).

Here's a compilation of the performance specifications, which act as the de facto acceptance criteria based on established predicate device performance:

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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 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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