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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:

• 1. Central Station
• 2. View Station
• 3. Work Station
• 4. 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.

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.

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The Spectrum monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the Spectrum device include the monitoring of the following human physiological parameters:

• ECG waveform derived from 3, 5 or 12 lead measurements
• Heart Rate derived from selected sources (ECG, SpO3, IBP, NIBP)
• Pulse Oximetry (SpO2, )
• ST Segment Analysis derived from 3, 5 or 12 ECG lead measurements
• Arrhythmia Detection derived from 3, 5 of 12 ECG lead measurements
• Interpretation of Resting 12 lead ECG
• Non Invasive Blood Pressure (NIBP)
• Invasive Blood Pressure (IBP) - up to four (4) channels
• Cardiac Output
• Respiration Rate/ waveform derived from ECG or CO2
• CO2, inspired and end tidal microstream/ waveform
• Temperature - up to two (2) channels
• Hemodynamic Calculations
• IV Drug Calculations

The Spectrum Monitor is an enhanced version of the Datascope Corp. Passport 2® Vital Signs Monitor with View 12™ ECG Analysis Module, previously cleared by FDA under K020550. There have been no significant changes to the Passport 2® Vital Signs Monitor with View 12 ™ ECG Analysis Module since its clearance. Datascope Corp. has modified the Passport 2® Vital Signs Monitor with View 12™ ECG Analysis Module by including the following parameters: Cardiac Output, Drug Calculations, Hemodynamic Calculations, a second Temperature, and two additional Invasive Blood Pressure Channels. The Spectrum monitor is a device that is used to monitor, display, trend and print a patient's physiological parameters. The device has a 12.1 inch color display and has a standard configuration of a 3 or 5 lead ECG, Masimo SET SpO2, Non- Invasive Blood Pressure (NIBP), Respiration, Continuous Temperature and IV Drug Calculations. Optional software includes ST and Arrhythmia Analysis. Optional hardware features include View12 ECG Analysis Module (which includes ST Arrhythmia and 12 Lead interpretation), up to 4 Invasive Blood Pressure Channels, Microstream CO2, Anesthetic Gases, Nellcor Oxismart SpO2, second temperature source, dual trace recorder, and Cardiac Output. A comprehensive calculation package including Hemodynamic Calculations is available if the Spectrum is equipped with an External Parameter Module. Digital displays are provided for Heart Rate, NIBP, SpO2, Respiration Rate, and Temperature. Optional digital displays are provided for up to four Invasive Blood Pressure, Anesthetic Agents, O2, and N20, ST and CO2, The optional internal recorder provides hard copies of all digital data and waveforms, as well as trend information.

The provided text describes a 510(k) summary for the "Spectrum Monitor" and a clearance letter from the FDA. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study design, sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies is not available in the provided document.

However, I can extract the general claims about testing and the overall conclusion.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, accuracy thresholds) and corresponding reported performance metrics are not detailed. The document states that the device was subjected to various tests and complies with voluntary standards, implicitly suggesting performance met certain established benchmarks.

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

This information is not provided in the given 510(k) summary. The document does not describe a clinical study with a defined test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given 510(k) summary. There is no mention of expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not provided as no specific test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

This information is not provided. The document does not describe an MRMC study or any comparison of human readers with and without AI assistance. The focus is on the device's performance compared to predicate devices, not on improving human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

While the device itself is a standalone monitor, the document does not detail specific "algorithm only" performance studies in a way that aligns with typical AI/algorithm standalone studies. It broadly mentions "Hardware and Software validation" and "Performance testing" but does not break down the results for specific algorithms independently. Given the device's nature as a multi-parameter patient monitor, its performance inherently involves algorithms, but a distinct "standalone" performance study akin to AI diagnostic tools is not described.

7. The Type of Ground Truth Used

The type of ground truth used for performance testing (e.g., expert consensus, pathology, outcomes data) is not specified in the provided summary. The document states "Performance testing" and "Hardware and Software validation" were conducted, implying ground truth was established to verify these, but the method is not elaborated upon.

8. The Sample Size for the Training Set

This information is not provided. There is no mention of a "training set" in the context of this 510(k) summary, as the device is presented as an enhanced version of an existing monitor rather than a new AI model requiring a distinct training phase description.

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

This information is not provided as no training set is described.

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