Search Results

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.

Ask a specific question about this device

The Accutorr 7 Vital Signs Monitor is intended for monitoring physiologic parameters, including SpO2, PR, NIBP and TEMP, on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians

The Accutorr 7 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.

The provided 510(k) summary for the Accutorr 7 Vital Signs Monitor (K132038) does not contain the detailed acceptance criteria or a specific study that proves the device meets those criteria in the typical format of a clinical or performance study with numerical endpoints.

Instead, the submission states:

"The Accutorr 7 Vital Signs Monitor comply with the recognized safety, performance and electromagnetic compatibility standards. A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. Mindray's product development process required that the following activities be completed during the development of those patient monitors:

Requirements specification review
Hardware and Software testing
Code design and code reviews
Environmental EMC testing
Wireless testing
Safety testing
Performance testing
Hardware and Software validation"

And concludes:

"The results of all testing demonstrate that the Accutorr 7 Vital Signs Monitor is as safe, as effective, and perform as well as the predicate devices."

This indicates that the device's performance was evaluated against internal requirements, recognized standards, and by demonstrating substantial equivalence to its predicate devices (VS-800 Vital Signs Monitor, K072235). The document does not provide a table of acceptance criteria with specific numerical targets or a study report detailing specific performance metrics (e.g., accuracy, precision) for SpO2, PR, NIBP, and TEMP, nor does it describe the methodologies for such studies.

Therefore, most of the requested information cannot be extracted from this document.

However, I can populate the table and answer the questions based on the general information provided, highlighting what is not explicitly stated as "N/A" (Not Applicable from this document) or "Not specified".

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document primarily refers to "Hardware and Software testing," "Performance testing," and "Hardware and Software validation" without detailing the sample sizes (e.g., number of patients, number of measurements) or the specific data used.
• Data Provenance: Not specified. (e.g., country of origin, retrospective/prospective).

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

• Not applicable. The document does not describe a study involving expert-established ground truth for a test set in a clinical context. The "testing" mentioned appears to be engineering and performance verification against standards and internal requirements, rather than a clinical trial with expert adjudication.

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

• Not applicable. No expert-based adjudication is described.

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 device is a vital signs monitor, not an AI-assisted diagnostic tool for human readers.

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

• The performance described is for the device as a standalone vital signs monitor. However, the exact methodology for this standalone performance (e.g., specific accuracy metrics against a reference standard) is not detailed in this summary. It states "Performance testing" was done, indicating some form of standalone evaluation.

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

• Not explicitly stated. For vital signs monitors, the "ground truth" for performance testing typically involves comparison against a reference standard device (e.g., a calibrated pressure manometer for NIBP, a co-oximeter for SpO2, a calibrated thermometer for TEMP, ECG for PR). The document does not specify these reference standards.

8. The sample size for the training set

• Not applicable. This vital signs monitor is not described as an AI/ML-based device that would typically involve a "training set."

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

• Not applicable, as it's not an AI/ML-based device with a "training set."

Ask a specific question about this device