The mVisum Alert Alarm Management System is software intended for use to display status and alarm events from other medical devices and patient information systems and associated physiological and other patient information. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. It is intended to be a secondary means of annunciating and displaying patient alarm and physiological information to mobile healthcare providers.

The mVisum Alert Alarm Management System is limited to use by qualified medical professionals who have been trained on the use of the system. It is intended to supplement and not to replace any part of the current patient monitoring systems. It is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.

Device Description

The mVisum Alert Alarm Management System is a software based secondary alarm notification system that transmits alarms, text and physiological waveform data from patient monitoring devices to a graphical display. This could be either on a PC or on a mobile device carried by a trained professional in a hospital environment. It is also capable of transmitting alarms and physiological waveforms to clinician smartphones that operate on the cell phone data network. The system receives alarm conditions from patient monitoring networks through industry standard HL-7 or XML formats and transmits the notification including any waveform data to the client software component. The client software component can then display the text and the physiological waveform information to the clinician.

The mVisum system only reads alarm information and does not change it or modify it in any way. It does not diagnose alarms but transmits what the Patient Monitoring System determines to be an alarm.

AI/ML Overview

The provided text describes the mVisum Alert Alarm Management System and its 510(k) clearance. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test/training sets, or information regarding ground truth establishment as requested.

The document states:

"Verification, validation, and testing activities establish the performance, functionality, and safety of the system. Testing included system level and regression tests as well as tests driven by the Hazard Analysis."

This is a general statement about testing but lacks the specifics needed to answer the questions about acceptance criteria and the study that proves the device meets them. The focus of this 510(k) summary is on demonstrating substantial equivalence to predicate devices for its intended use as a secondary alarm notification system, rather than presenting a performance study with detailed metrics against specific acceptance criteria.

Therefore, I cannot populate the table or answer most of the questions using only the provided text.

Here's an overview of what can be extracted and a clear indication of what information is missing:

Description of the Acceptance Criteria and Study (Based on available information):

The provided 510(k) summary for the mVisum Alert Alarm Management System does not detail specific quantitative acceptance criteria or a dedicated clinical study proving the device meets them. Instead, it relies on system-level and regression testing, along with a hazard analysis, to demonstrate performance, functionality, and safety. The primary method for clearance appears to be substantial equivalence to predicate devices (GE / Data Critical Corporation Statview System and GE Web Viewer, Pocket Viewer, Cellular Viewer) based on its technological characteristics and intended use as a secondary alarm notification system. The device's function is to transmit existing alarms and physiological data, not to generate or interpret diagnostic information.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Quantitative, if available)	Reported Device Performance (Quantitative, if available)
Not specified in the provided text.	Not specified in the provided text.
(The document mentions "Verification, validation, and testing activities establish the performance, functionality, and safety of the system. Testing included system level and regression tests as well as tests driven by the Hazard Analysis." but does not provide specific metrics or acceptance thresholds.)	(No quantitative performance metrics are reported in the provided text.)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: Not specified in the provided text. (The device transmits data from "patient monitoring devices," but no specific dataset or its origin for testing is mentioned.)
Retrospective/Prospective: Not specified in the provided text.

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

Number of Experts: Not applicable. The device is a secondary notification system; it does not perform diagnostic functions that would require expert-established ground truth for its performance. It simply relays alarms from primary monitoring systems.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. (As above, this is a relay system, not a diagnostic or interpretive device that would require adjudication of findings.)

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

MRMC Study: No. The device is not an AI-assisted diagnostic tool; it is a system for transmitting alarms and physiological data. Therefore, an MRMC comparative effectiveness study to assess human reader improvement with AI assistance is not relevant to this device's function and was not conducted or reported.
Effect Size: Not applicable.

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

Standalone Performance Study: The document describes "system level and regression tests" to establish performance and functionality. While these tests evaluate the software's ability to transmit data, they are not presented as a standalone diagnostic performance study in the way this question typically implies (e.g., sensitivity/specificity for disease detection). The device's primary function is data relay, not independent diagnostic assessment.

7. The type of ground truth used

Type of Ground Truth: Not explicitly stated as "ground truth" for a diagnostic purpose. The system's "truth" is whether it accurately receives and transmits the alarm events and physiological data as determined by the primary patient monitoring systems. The device does not establish its own diagnostic ground truth.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/Not specified. This device is not described as using machine learning or AI that would involve a training set. It is a software system for data transmission.

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

Ground Truth Establishment for Training Set: Not applicable. (No training set is mentioned as part of the device's development or testing.)

Summary

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K11 2282 P1/2

NOV - 4 2011

601

m Visum,

Bringing Mobility to Healthcare

510(k) SUMMARY:

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92(c).

Submitter:	mVisum, Inc.200 Federal Street, Suite 230Camden, NJ 08103
Contact Person:	Praveen DalaPresident and CEOPhone: 856-513-0732Fax: 856-513-0729
Date	August 05, 2011
Trade Name:	mVisum Alert Alarm Management System
Common/Usual Name:	Physiological Monitor System, Network and Communication (PatientInformation Paging System)

Classification (if known):

Device Panel	Classification	Prod.Code	Description
CardiovascularDevices	§870.2300Class II	MSX	Cardiac Monitor(includingcardiotachometerand rate alarm)

Predicate Devices:

mVisum Alert Alarm Management System is substantially equivalent to previously cleared GE / Data Critical Corporation Statview System pursuant to K990378 and GE Web Viewer, Pocket Viewer, Cellular Viewer pursuant to K061994.

Device Description:

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m Visum, Inc.

Bringing Mobility to Healthcare

waveforms to clinician smartphones that operate on the cell phone data network. The system receives alarm conditions from patient monitoring networks through industry standard HL-7 or XML formats and transmits the notification including any waveform data to the client software component. The client software component can then display the text and the physiological waveform information to the clinician.

The mVisum system only reads alarm information and does not change it or modify it in any way. It does not diagnose alarms but transmits what the Patient Monitoring System determines to be an alarm.

Intended Use:

The mVisum Alert is limited to use by qualified medical professionals who have been trained on the use of the system. It is intended to supplement and not to replace any part of the current patient monitoring systems. It is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.

Predicate Devices

The product has the same technological characteristics as the legally marketed predicate devices. . The mVisum Alert Alarm Management System and the predicate devices serve as secondary means of annunclating patient events and relaying information from the primary monitoring station through the use of a graphical user interface on a mobile device. The product has the same safety and efficacy characteristics as the predicate devices.

Testing

Verification, validation, and testing activities establish the performance, functionality, and safety of the system. Testing included system level and regression tests as well as tests driven by the Hazard Analysis.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

NOV - 4 2011

mVisum. Inc. c/o Mr. Praveen Dala, Ph.D. President and CEO 200 Federal Street. Suite 230 Camden, NJ 08103

Re: K112282

Trade/Device Name: mVisum Alert Alarm Management System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Codes: MSX Dated: August 5, 2011 Received: August 9, 2011

Dear Mr. Dala:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 -- Mr. Praveen Dala, Ph.D.

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-100,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1 1 5809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Press. 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

5:10(k) Number (if known): 长川2282

Device Name: mVisum Alert Alarm Management System

İndications for Use:

・・・・・

Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number k//2 ≥ 82

Page 1 of 1

01 001

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).