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ENSEMBLE includes the essential features of a central station monitor for up to 12 patients. It can display vital signs information collected from bedside patient monitoring devices such as: ECG/Heart Rate, Arrhythmia (basic and extended alarms), ST Segment, Respiration, Temperature, Invasive Blood Pressure, Noninvasive Blood Pressure, Pulse Oximetry, and End Tidal carbon-dioxide. The ENSEMBLE may be used in system application in many different clinical specialties within the hospital.

ENSEMBLE is hospital based, multi-patient, multi-parameter display terminal. As such, it is a component in a physiological patient vital signs monitoring system.

A system consists of any of the several possible combinations of the following components: Bedside Devices

HORIZON XL patient monitor, and/or 219 TELEMETRY RECEIVER/TRANSMITTER with NS-7, (K911616, and K895395, respectively) Ethernet™ Communication Network Documentation Peripherals (Chart Recorders and Laser Printers), and

ENSEMBLE Central Station Monitor.

ENSEMBLE acquires patient vital signs, waveforms and alarm indications from Mennen Medical HORIZON XL and 219 TELEMETRY systems. All processing and alarm determination is made in these "bedside devices", using proprietary algorithms and software contained therein. Processed information is communicated from the bedside devices to one or more ENSEMBLE Central Station Monitors by the Mennen Medical ENSEMBLE system Ethernet™ network. If documentation is requested, information is transmitted to the appropriate Documentation Peripheral, using the same network.

Although ENSEMBLE does not make alarm determinations, it does provide users with a remote interaction capability, allowing users to make changes to both parameter and alarm settings in the remote bedside devices. Similarly, ENSEMBLE users have a remote interactive capability to initiate recordings or printing of patient information and waveforms.

Vital signs and waveform information from up to 12 patients are be displayed simultaneously on an ENSEMBLE Central Station Monitor. Information from each individual patient is presented in a separate portion of the display. Each patient display area includes: Patient Name, Assigned Location (room), Primary Vital Sign Name, Value & Alarm Limits (nominally Heart Rate), Primary Waveform (nominally ECG), Secondary Vital Sign Numeric Data, Alarm Status Messages, and a dedicated "soft key" for recording waveforms. Software configurations allow more than one waveform or parameter to be displayed for each patient.

Primary operation of the ENSEMBLE is accomplished by a desktop mouse. A standard computer keyboard is used for manual entry of alphanumeric information. An optional touchscreen is available for users who prefer to use a touchscreen. Alternative "desktop devices", such as trackball and light pen, are also available as options. For large installations, with several ENSEMBLEs intended for a single user, the system may be configured to enable one keyboard and one mouse to control up to eight individual ENSEMBLE computers.

ENSEMBLE is a reusable, software driven, central station display terminal, intended for use as part of a physiological monitoring system in a hospital environment. As such it is not a life supporting, or life sustaining device; nor is it implantable and therefore sterility is not a consideration. ENSEMBLE complies with UL 544, ANSI Safe Current Limits for Electromedical Apparatus, and FDA MDS-201-0004 voluntary standards. ENSEMBLE is not a kit, does not contain any drug or biological products and is for prescription use,

The provided text is a 510(k) Summary for the ENSEMBLE Central Station Monitor. This document describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on regulatory approval rather than a detailed scientific study with acceptance criteria and performance data.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted directly from this document. The document primarily focuses on demonstrating regulatory compliance and substantial equivalence.

Here's an explanation based on the limited information found in the document, and what is missing:

The document states:
"ENSEMBLE complies with UL 544, ANSI Safe Current Limits for Electromedical Apparatus, and FDA MDS-201-0004 voluntary standards." and "AAMI/ANSI ES11 Safe Current Limits for Electromedical Devices AAMI/ANSI EC13, Cardiac Monitors, Heart Rate Meters and Alarms UL-544"

This indicates that the "acceptance criteria" are likely based on adherence to these voluntary standards for electrical safety and performance of cardiac monitors. However, no specific performance metrics (e.g., accuracy of heart rate measurement, alarm response time) are provided in the way requested in the prompt.

Missing Information:

• A table of acceptance criteria and reported device performance: No such table is present. The document mentions compliance with standards but does not quantify performance against specific criteria.
• Sample sized used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method: Not mentioned.
• 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 mentioned. The device is a display terminal, not an AI-driven diagnostic tool in the sense of the prompt.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. The device is a "multi-patient, multi-parameter display terminal" and explicitly states, "All processing and alarm determination is made in these 'bedside devices', using proprietary algorithms and software contained therein." ENSEMBLE acquires information and displays it.
• The type of ground truth used: Not applicable in the context of the provided document, as it describes a display device that presents data processed by other "bedside devices."
• The sample size for the training set: Not applicable and not mentioned, as this is not an AI algorithm development study.
• How the ground truth for the training set was established: Not applicable and not mentioned.

Summary of available information related to "acceptance criteria" and "study":

• UL 544
• AAMI/ANSI ES11 Safe Current Limits for Electromedical Devices
• AAMI/ANSI EC13, Cardiac Monitors, Heart Rate Meters and Alarms
• FDA MDS-201-0004 |
  | Reported Device Performance | The document states the device "complies" with the listed standards. No specific performance metrics (e.g., accuracy, sensitivity, specificity) against these standards are provided for the ENSEMBLE specifically. The device is a display terminal; processing and alarm determination happen in "bedside devices." |
  | Study that proves device meets acceptance criteria | The document is a 510(k) summary, aiming to demonstrate substantial equivalence to predicate devices (MENNEN MEDICAL COMPREHENSIVE CENTRAL STATION (K892066) and HEWLETT-PACKARD M2360A WAVEVUE CENTRAL MONITOR (K921014)). It implies that compliance with the voluntary standards, along with the description of the device's functionality and safety features, constitutes the evidence for meeting "acceptance criteria" for regulatory clearance. It does not describe a scientific study with a test set, ground truth, or statistical analysis. |

In conclusion, the provided document is a regulatory submission (510(k) Summary) that outlines the device's characteristics and its substantial equivalence to predicate devices under existing standards. It does not contain the detailed scientific study information, ground truth methods, or specific performance metrics typically found in a clinical study report for an AI/ML-driven diagnostic device.

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