The Acuity® Central Monitoring System, in all configurations including the hardwired and wireless Acuity LT and Mobile Acuity LT System configurations, is intended to be used by clinicians for the central monitoring of neonatal, pediatric and adult patients in healthcare facilities.

In addition to the central monitoring of patient data, waveforms, and alarms and alerts, Acuity System software can include optional modules to provide extended recording and analysis of patient data. Acuity System software can include the following optional modules:

. The Full Disclosure module stores patient data for up to 96 hours (24 hours with Acuity LT and . Mobile Acuity LT).
. The Arrhythmia Analysis module provides real-time monitoring and alarms for specific changes in cardiac rhythms. The clinician is responsible for determining the clinical significance of each detected arrhythmia event or alarm. The Arrhythmia Analysis module is not intended for use with neonatal patients.
. The ST Analysis module provides real-time monitoring and alarms for ST segment deviations for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST Analysis option is not intended for use with neonatal patients.
. The Welch Allyn Connectivity Server (WACS) module consists of a server platform on which one or more of the following software options are installed: Link To Acuity (Acuity System patient information delivered to mobile devices running Clinician Notifier software), Web Server (Acuty System patient printout files available on Web browsers) and HL7 options.

Device Description

The Full Disclosure module stores patient data for up to 96 hours (24 hours with Acuity LT and . Mobile Acuity LT).
. The Arrhythmia Analysis module provides real-time monitoring and alarms for specific changes in cardiac rhythms. The clinician is responsible for determining the clinical significance of each detected arrhythmia event or alarm. The Arrhythmia Analysis module is not intended for use with neonatal patients.
. The ST Analysis module provides real-time monitoring and alarms for ST segment deviations for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST Analysis option is not intended for use with neonatal patients.
. The Welch Allyn Connectivity Server (WACS) module consists of a server platform on which one or more of the following software options are installed: Link To Acuity (Acuity System patient information delivered to mobile devices running Clinician Notifier software), Web Server (Acuty System patient printout files available on Web browsers) and HL7 options.

The Link To Acuity option is Welch Allyn's mobile alarm management solution. It consists of Clinician Notifier software for non-proprietary mobile devices and administrative software for the Welch Allyn Connectivity Server (WACS).

Mobile devices running the Clinician Notifier software deliver patient alarm information and real-time waveforms gathered from patient monitors connected to the Acuity Central Monitoring System. The devices are not intended for use as primary alarm notification devices. Devices running Clinician Notifier software are not directly connected to patients.

The Link To Acuity option is designed to extend the patient monitoring functions of the Acuity Central Monitoring System. The software enables administrators to track the status of clinician-patient assignments, and it enables clinicians to track, respond to and view Acuity System patient alarms, view historical alarm details and waveforms, and view real-time patient waveforms. The mobile devices can be used for barcode scanning to enter patient ID and room number.

The Link To Acuity option is to be used by authorized health care professionals using standard institutional procedures and good clinical practice guidelines for patient monitoring. Staff training in the operation of the Link To Acuity option is essential for optimal use. Users should be skilled at the level of a technician, nurse, physician, health care provider or medical specialist, with the knowledge and experience to acquire and interpret patients' vital signs data.

Individuals using the Link To Acuity option should be familiar with its operation as described in the directions for use manual, and they should understand all warnings and cautions in the directions for use manual.

AI/ML Overview

This document, a Special 510(k) Premarket Notification for the "Link To Acuity® Clinician Notifier Option (Modification to Acuity® Central Monitoring System)", describes a software modification to an existing central monitoring system. The focus is on a mobile alarm management solution, and as such, the performance data presented is related to software testing and clinical entry testing for the specific Clinician Notifier component, rather than broad physiological monitoring accuracy.

Based on the provided text, the document does not contain detailed acceptance criteria and reported device performance in a tabulated format as typically expected for medical device performance studies, especially those involving diagnostic accuracy or clinical outcomes. Instead, it refers to internal testing documents.

Here's an analysis of the information available and what is not provided, broken down into your requested categories:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with corresponding reported device performance values. It lists internal Welch Allyn documents that describe testing activities:

830-1423-00: Test Plan, Acuity V7.00
831-1285-00: Pre-Validation Clinical Entry Test Report Clinician Notifier 2.35/WACS 2.10.00
830-1472-00: Welch Allyn Link to Acuity® - Simulated Clinical Engineering Test Protocol
831-1248-00: Link To Acuity® Simulated Clinical Testing Report

These documents, which are not included, would contain the specific acceptance criteria and detailed performance results. The narrative only states that the device was tested "in accordance with the following Welch Allyn documents using production equivalent units prior to market release." The nature of the device (alarm notification and information viewing) suggests that acceptance criteria would likely focus on:

Reliability: Successful delivery of alarms and real-time data to mobile devices.
Timeliness: Latency of alarm delivery.
Accuracy: Correct display of patient information and waveforms as transmitted from the central system.
Functionality: Proper operation of features like patient assignment, alarm response, and security (login/logout).
Usability/Human Factors: (Likely covered by the "Pre-Validation Clinical Entry Test Report" to some extent).

Since these detailed performance metrics are not explicitly stated, a table cannot be constructed from the provided text.

The following questions relate to specific types of studies, and the document largely indicates that these types of clinical performance studies (e.g., diagnostic accuracy, comparative effectiveness with human readers) were not performed or are not detailed in this 510(k) summary. This is consistent with a "Special 510(k)" for a software modification that extends the functionality of an already cleared central monitoring system for notification purposes, rather than a novel diagnostic AI algorithm.

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

The document refers to a "Pre-Validation Clinical Entry Test Report Clinician Notifier 2.35/WACS 2.10.00" and a "Link To Acuity® Simulated Clinical Testing Report".

Sample Size: Not specified in the provided text for either clinical entry or simulated testing.
Data Provenance: Not specified. Given the nature of a "Special 510(k)" for a software modification, extensive novel clinical data from external sources is less common. "Simulated Clinical Testing" implies controlled, non-patient data or scenarios. "Clinical Entry Test Report" suggests some form of testing in a clinical environment, but details are absent.
Retrospective/Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is not performing a diagnostic or interpretive task that requires expert-established ground truth in the traditional sense of a diagnostic AI study. The "ground truth" for an alarm notification system would be the alarm generated by the central monitoring system and the accuracy of its delivery and display on the mobile device. The internal testing would verify the software's correct function. The "Pre-Validation Clinical Entry Test Report" would likely involve clinical users (nurses, physicians) evaluating the system's usability and functionality, but not establishing a diagnostic ground truth.

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

Not applicable for the reasons stated in point 3. There is no diagnostic ground truth established by multiple experts requiring an adjudication method.

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

No, an MRMC comparative effectiveness study was not done or is not reported in this document. This type of study is relevant for AI algorithms that perform diagnostic tasks that human readers also perform, to show improvement in diagnostic accuracy or efficiency with AI assistance. The "Link To Acuity Clinician Notifier" is a notification and information display system, not a diagnostic AI.

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

The "Link To Acuity Clinician Notifier" is inherently a "human-in-the-loop" device, as its purpose is to deliver information to a human clinician for action. The underlying "Arrhythmia Analysis module" and "ST Analysis module" of the main Acuity system do perform standalone algorithmic analysis (e.g., detecting arrhythmias, ST segment deviations), and their performance would have been established in previous 510(k) submissions (e.g., K052160 for the Acuity® Central Monitoring Station). This current submission is for the notifier component, which relays the results of those analyses. Therefore, its performance is measured by its ability to deliver existing data, not by its own standalone diagnostic accuracy. The "Simulated Clinical Engineering Test Protocol" and "Simulated Clinical Testing Report" would likely cover the standalone software function of the notifier (e.g., proper routing, display), but not diagnostic performance.

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

For the "Link To Acuity Clinician Notifier," the "ground truth" would be the accurate and timely transmission and display of patient data (waveforms, alarms, alerts, patient info) as generated by the already-cleared Acuity Central Monitoring System. It's about data fidelity and system functionality, not diagnostic accuracy requiring pathology or outcomes data.

8. The sample size for the training set

Not applicable. The "Link To Acuity Clinician Notifier" is a software application designed for alarm management and information display. It is not an AI/ML algorithm that is "trained" on a dataset to learn patterns or make predictions in that sense. It processes and transmits data based on predefined rules and algorithms.

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

Not applicable for the reasons stated in point 8. The device does not involve a training set for an AI/ML model.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Welch Allyn. The text is in a bold, sans-serif font. The logo is black and the background is white.

Special 510(k) Premarket Notification Link To Acuity® Clinician Notifier Option (Modification to Acuity® Central Monitoring System)

Premarket Notification [510(k)} Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness, is outlined below.

Date Prepared:	March 5, 2007
Name of Submitter:	Welch Allyn Protocol, Inc.8500 S.W. Creekside PlaceBeaverton, OR 97008-7107 USAContact:Jeffrey W. Wagner, Director, Regulatory AffairsPhone: (503) 530-7909Fax: (503) 526-4901
Device Proprietary Name:	Link To Acuity® Clinician Notifier(Modification to the Acuity® Central Monitoring System)
Classification Name:	System, network and communication, physiological monitors (MSX)Detector and Alarm, Arrhythmia (DSI)
Common/Usual Names:	Central monitoring system

Predicate Devices:

K052160	Acuity® Central Monitoring Station	Welch Allyn Protocol, Inc.
K052975	S/5 Pocket Viewer	Datex-Ohmeda

Device Description:

The Full Disclosure module stores patient data for up to 96 hours (24 hours with Acuity LT and . Mobile Acuity LT).
MAR 2 3 2007

K070204/51

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WelchAllyn

Special 510(k) Premarket Notification Link To Acuity® Clinician Notifier Option (Modification to Acuity® Central Monitoring System)

C7C20451 72/3

. The Arrhythmia Analysis module provides real-time monitoring and alarms for specific changes in cardiac rhythms. The clinician is responsible for determining the clinical significance of each detected arrhythmia event or alarm. The Arrhythmia Analysis module is not intended for use with neonatal patients.
. The ST Analysis module provides real-time monitoring and alarms for ST segment deviations for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST Analysis option is not intended for use with neonatal patients.
. The Welch Allyn Connectivity Server (WACS) module consists of a server platform on which one or more of the following software options are installed: Link To Acuity (Acuity System patient information delivered to mobile devices running Clinician Notifier software), Web Server (Acuty System patient printout files available on Web browsers) and HL7 options.

Technological Characteristics:

The Welch Allyn Link To Acuity Clinician Notifier option allows for alarm management remote from the central monitoring station. Through a network of wireless and/or hardwired devices connected to the Welch Allyn Acuity Central Monitoring System, alarms, real time data, and other information can be viewed from a generic mobile computer configured with Welch Allyn Link To Acuity Clinician Notifier option software. The Welch Allyn Link To Acuity Clinician Notifier is to be used as a supplement to other patient monitoring and not as a primary alarm notification device.

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WelchAllyn

Special 510(k) Premarket Notification Link To Acuity® Clinician Notifier Option (Modification to Acuity® Central Monitoring System)

<07020451 $ 3/3

Link To Acuity® Clinician Notifier Features

View Patient Info

Status of all patients in unit History of alarms Real-time waveform List of current alarms Details of an alarm

Respond to Alarms and Alerts

Patient alarms delivered to Clinician Notifier devices Two possible alarm delivery modes - Escalation and Broadcast Alarm notifications Respond to patient alarms

Security

Patient Assignment

Assign patients to clinicians Enter and confirm a patient's ID

Performance Data:

The subject device has been tested in accordance with the following Welch Allyn documents using production equivalent units prior to market release.

830-1423-00	Test Plan, Acuity V7.00
831-1285-00	Pre-Validation Clinical Entry Test Report Clinician Notifier 2.35/WACS 2.10.00
830-1472-00	Welch Allyn Link to Acuity® - Simulated Clinical Engineering Test Protocol
831-1248-00	Link To Acuity® Simulated Clinical Testing Report

A risk analysis identifying potential hazards and documenting mitigation of the hazards has been developed and applied as part of Welch Allyn Protocol's product development procedure. Welch Allyn Protocol's Quality System conforms to 21 CFR 820 and is certified to ISO 13485:2003.

Conclusion:

Based on the information contained in this submission, Welch Allyn Protocol, Inc. believes that the subject device is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2007

Welch Allyn Protocol, Inc. c/o Mr. Jeffrey Wagner Director, Regulatory Affairs 8500 SW Creekside Place Beaverton, OR 97008

Re: K070204

Trade/Device Name: Link to Acuity Clinical Notifier Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MSX Dated: March 12, 2007 Received: March 13, 2007

Dear Mr. Wagner:

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 such 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.

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Page 2 - Mr. Wagner

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blyminima for

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

Enclosure

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K070204/S1

Special 510(k) Premarket Notification Link To Acuity® Clinician Notifier Option (Modification to Acuity® Central Monitoring System)

Statement of Indications for Use

. The Full Disclosure module stores patient data for up to 96 hours with Acuity LT and Mobile Acuity LT).
. The Arrhythmia Analysis module provides real-time monitoring and alarms for specific changes in cardiac rhythms. The clinician is responsible for determining the clinical significance of each detected arrhythmia event or alarm. The Arrhythmia Analysis module is not intended for use with neonatal patients.
. The ST Analysis module provides real-time monitoring and alarms for ST segment deviations for patients with suspected heart disease and anomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST Analysis option is not intended for use with neonatal patients.
. The Welch Allyn Connectivity Server (WACS) module consists of a server platform on which one or more of the following software options are installed: Link To Acuity System patient information delivered to mobile devices running Clinician Notifier software), Web Server (Acuity System patient printout files available on Web browsers) and HL7 options.

Applicant:

Welch Allyn Protocol, Inc. 8500 S.W. Creekside Place Beaverton, OR 97008-7107 USA

510(k) Number: K070204

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

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Office of Device Evaluation (ODE)
-----------------------------------

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K070204

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).