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.

Device Description

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,

AI/ML Overview

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":

Requirement	Description (from document)
Acceptance Criteria	Based on compliance with voluntary standards: - 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.

Summary

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97035-8

FEB 11 1998

Image /page/0/Picture/2 description: The image shows the logo for Mennen Medical. The logo consists of a stylized lowercase "m" inside of a black circle, followed by the words "mennenmedical" in a sans-serif font. The word "mennen" is in bold, while "medical" is in regular font.

1992-2

MENNEN MEDICAL LTD. Kirvat Weizmann Science Park P.O.B. 102

Rehovot 76100 Israel Tel: 972-8-938-3030 Fax: 972-8-940-6519

10 November 1997 Date:

Food and Drug Administration To: Center for Devices and Radiological Health Document Control Center (HFZ-401) 1390 Piccard Drive Rockville MD 20850
Document Control Clerk Attn.:
Kenneth Raichman From: Director of Regulatory Affairs

510(k) Summary Topic: ENSEMBLE Central Station Monitor Safety and Effectiveness

Product Name

Proprietary:	ENSEMBLE
Common:	Physiological Monitoring System, Central Station Display Terminal

Establishment Registration Number and Address

Registration Number 9611022 Mennen Medical LTD. Alan Schwebel, Ph.D. President Kiryat Weizmann Science Park Rehovot 76100 Israel Tel: 972-8-938-3030

Classification (Section 513)

Classification: Panel:

Anesthesiology and Respiratory/Cardiology

Performance Standards

None Established.

Voluntary Standards

AAMI/ANSI ES11 Safe Current Limits for Electromedical Devices AAMI/ANSI EC13, Cardiac Monitors, Heart Rate Meters and Alarms UL-544

Class III

Predicate Devices

MENNEN MEDICAL COMPREHENSIVE CENTRAL STATION (K892066). HEWLETT-PACKARD M2360A WAVEVUE CENTRAL MONITOR (K921014).

Date Prepared

10 November 1997

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Food and Drug Administration

Page 2 of 7.

510(k) Summary, ENSEMBLE Safety & Effectiveness

Device Description

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

ENSEMBLE Central Station Monitor.

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Image /page/2/Picture/2 description: The image shows a stylized emblem or logo. It features a graphic of a bird-like figure with three curved lines representing its body or wings. The emblem also includes text, with the letters 'DEPA' visible at the bottom and partial text around the top edge, including 'HUMAN' and 'USA'.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 11 1998

Allen Schwebel, Ph.D. Mennen Medical Ltd. Kiryat Weizmann Science Park P.O.B. 102 Rehovot 76100 ISRAEL

K970358 Re: Ensemble Central Station Monitor Requlatory Class: ... III (tbree) Product Code: 74 DSI Dated: November 10, 1997 November 13, 1997 Received:

Dear Dr. Schwebel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Food and Drug Administration

510(k) Summary, ENSEMBLE Safety & Effectiveness

10 November 1997

97035

Page 3 of 7.

Indications for Use:

Mr. Pugh

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number _ 29703

Prescription

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.