The Acuity® Central Monitoring Station is intended to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities.

In addition to the central monitoring of patient data, waveforms, alarms and alerts, the Acuity software can include optional modules to provide extended recording of patient data (Full Disclosure), arrhythmia monitoring and ST analysis.

Full Disclosure stores patient data for up to 96 hours. .
Arrhythmia monitoring module provides real-time monitoring and alarms for specific . changes in cardiac rhythms. The clinician is responsible for determining the clinical eilance of each detected arrhythmia event or alarm. The arrhythmia module is not intended for use with neonatal patients.
ST analysis module provides real-time monitoring and alarms for ST segment . B r unalyons from a reference beat, for patients with suspected heart disease and avomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST analysis module is not intended for use with neonatal patients.

Device Description

The Acuity® Central Monitoring Station is Welch Allyn's Central Monitoring solution. It consists of the I no routy® Central Monitoring Station, the Acuity software and a collection of other commercially available networking hardware products. The system connects to a network of patient monitors to record and analyze the data being acquired by those devices. This solution offers a proven record and untily to the auto and features needed to support a distributed network of connected devices while providing arrhythmia detection and alarms for adult and pediatric patients.

The Acuity system supports patient information management, patient alert and alarm management, rite noaty oyotem administration and product installation and service. It leverages various networking and connectivity options to obtain and distribute information where and when needed.

Acuity is available in multiple product configurations. Acuity systems can be ordered off-the-shelf or custom configured to meet a customer's unique needs based on hospital policy, healthcare Shell of custom conlingured to meet a oaster. In all cases, the user must carefully review the features facility size, patient cerisus and noor rayour and the Acuity® Central Monitoring Station to ensure that clinical needs are met.

The Acuity® Central Monitoring Station is not directly connected to patients. It is designed to be used The Aculty® Octitur Monitoring Station of patient monitors supporting both continuously and as a central monkoning oyeten for a sites supported include, but are not limited to, the following interfilterity acquired duta: The mentlers supported to interface with Acuity.

Acuity systems monitor patient data supplied by a bedside monitor and do further processing of that Aculty Systems monitor pation acts eappliering Station. Acuity systems with the arrhythmia option data by Sollware at the Acally® Oontral mornethmia analysis algorithms, where the bedside calculate heart rate algorithm based on data from a single ECG lead. The overall performance monitor uses a ficult rato algontining and data management techniques consistent with industry practice and applicable standards.

It is important to note that some Acuity software options and/or devices will support adult and it is important to not other neonatal patients. Specifically, the ST Analysis and Arrhythmia Analysis software options are intended only for adult and pediatric patients.

Acuity® Central Monitoring Stations and distributed monitoring devices are prescription devices to be Aculty® Ochrail Mohitoring blancher by institutional standard procedures and good clinical practice guidelines for monitoring of specific patients. Staff trained in the operation of Acuity clinical praction monitoring devices connected to it is essential for optimal use. System users should and the patient monitoring doniose connese, physician, healthcare provider or medical specialist.

AI/ML Overview

The Acuity® Central Monitoring Station is an arrhythmia detector and alarm system. The summary provided outlines its acceptance criteria and performance data.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (Predicate Device K022453)	Reported Device Performance (Acuity® Central Monitoring Station)
QRS Detection Sensitivity	AHA 99.88, MIT 99.93	AHA 99.86, MIT 99.95
QRS Positive Predictivity	N/A (not explicitly listed for predicate)	99.89
Ventricular Sensitivity	N/A (not explicitly listed for predicate)	93.26
Ventricular Positive Predictivity	N/A (not explicitly listed for predicate)	98.21

Note: The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new, specific acceptance criteria beyond what the predicates met. The "Acceptance Criteria" column refers to the predicate device's performance, which the subject device aims to meet or exceed to prove substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for a "test set" in the traditional sense of a clinical trial. The performance data presented (QRS Sensitivity, Predictivity, Ventricular Sensitivity, Predictivity) are common metrics for arrhythmia detection algorithms, typically evaluated against standardized databases.

Sample Size: Not explicitly stated as a single "test set" size. The performance metrics are likely derived from evaluation against recognized datasets like the AHA (American Heart Association) and MIT (Massachusetts Institute of Technology) arrhythmia databases, which contain a large number of ECG recordings.
Data Provenance: The data refers to "AHA" and "MIT," which are well-known, publicly available, and extensively used retrospective ECG databases for arrhythmia algorithm testing. These databases consist of recordings from various patients and are widely accepted for benchmarking. The country of origin for these databases is primarily the United States (MIT) and, for AHA, data can be internationally sourced but compiled under AHA standards. The data is retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish the ground truth for the test sets (AHA and MIT databases). For these widely used databases, the ground truth annotations were established by a panel of expert cardiologists or electrophysiologists based on visual inspection and agreed-upon guidelines, long before the Welch Allyn study. The exact number and specific qualifications of those original annotators are not provided in this document but are part of the original database documentation.

4. Adjudication Method for the Test Set

The document does not describe a new adjudication method for a specific test set created by Welch Allyn. For the AHA and MIT databases, the ground truth labels are pre-established through expert consensus during the creation of these databases. The exact adjudication method (e.g., 2+1, 3+1) used for the original annotation of these large public databases is not detailed in this 510(k) summary but would have involved multiple experts reviewing and agreeing upon classifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to evaluate human reader improvement with AI assistance. The study focuses on the standalone performance of the device's arrhythmia detection algorithms compared to predicate devices and established benchmarks.

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

Yes, a standalone (algorithm only) performance evaluation was done. The provided "QRS Detection Sensitivity," "QRS Positive Predictivity," "Ventricular Sensitivity," and "Ventricular Positive Predictivity" are metrics that assess the algorithm's performance directly against the ground truth of the ECG databases (AHA and MIT) without human intervention in the loop.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance metrics (QRS and Ventricular detection) is based on expert consensus annotations from the AHA and MIT ECG databases. These databases contain expertly reviewed and annotated ECG waveforms over extended periods, identifying QRS complexes and various arrhythmia events.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for the training set used to develop the Acuity® Central Monitoring Station's arrhythmia algorithms. 510(k) summaries typically focus on the performance against independent test sets for substantial equivalence, not the details of algorithm development (training data, methodology, etc.).

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established. As with the test set, it is highly probable that the training data would also have been expertly annotated, likely using similar methodologies (expert consensus) as the publicly available test databases or proprietary datasets.

Summary

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DEC 16 2005

Image /page/0/Picture/2 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The first line reads 'K052160', and the second line contains the fraction '1/4'. The handwriting is somewhat rough, with varying stroke thicknesses, suggesting it may have been written quickly or with a thick marker.

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with This summaly of STO(K) sailety and enocifical mornation supporting claims of substantial the requirements of OMDA 1000 and E. R. R. S. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . effectiveness is outlined below.

Date Prepared:	July 27, 2005
Name of Submitter:	John E. SawyerDirector, World Wide Regulatory AffairsWelch Allyn, Inc4341 State Street RoadSkaneateles Falls, NY 13153-0220
Device Proprietary Name:	Acuity® Central Monitoring Station
Classification Name:	Arrhythmia Detector and Alarm (Including ST Segment andAlarm)
Common/Usual Names:	Arrhythmia Detector and Alarm
Predicate Device:	The subject device has the same indications for use as thepredicates.
	K022453	Acuity® Central Monitoring System	Welch Allyn Protocol, Inc.
	K972121	Acuity Central Station	Protocol Systems, Inc.
	K935846	Model Acuity Central Station	Protocol Systems, Inc.

Device Description:

Acuity® Central Monitoring Station Product Code: DSI and MLD CFR Section: 870.1025

Acuity is available in multiple product configurations. Acuity systems can be ordered off-the-

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Image /page/1/Picture/0 description: The image shows the brand name "WelchAllyn" in a bold, serif typeface. The letters are closely spaced, giving the word a compact appearance. The brand name is likely associated with medical devices or healthcare solutions.

510(k) Summary - Acuity® Central Monitoring Station

shelf or custom configured to meet a customer's unique needs based on hospital policy, healthcare Shell of custom conlingured to meet a oaster. In all cases, the user must carefully review the features facility size, patient cerisus and noor rayour and the Acuity® Central Monitoring Station to ensure that clinical needs are met.

Indications For Use

The Acuity® Central Monitoring Station is intended to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities.

Full Disclosure stores patient data for up to 96 hours. .
r an blood an entoring module provides real-time monitoring and alarms for specific changes in . cardiac rhythms. The clinician is responsible for determining the clinical significance of each cardido mythmia event or alarm. The arrhythmia module is not intended for use with neonatal patients.
pations.
ST analysis module provides real-time monitoring and alarms for ST segment deviations, from a . reference beat, 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 module is not intended for use with neonatal patients.

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Image /page/2/Picture/1 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.

Technological Comparison to Predicate Devices:

	Subject	Predicate
		Welch Allyn Protocol	Protocol Systems
Manufacturer	Welch Allyn Protocol		K935846 / K972121
510(k) Number	Pending	K022453
Device Name	Acuity® Central MonitoringStation	Modification toAcuity Central MonitoringSystem	Acuity Central Station
ClassificationCode	Pending	DSI	MLD
Patient Population	Neonate, Pediatric, AdultNo arrhythmia support orST analysis for neonate	Neonate, Pediatric, AdultNo arrhythmia support orST analysis for neonate	Neonate, Pediatric, AdultNo arrhythmia support orST analysis for neonate
Use Environment	Medical/Clinical	Medical/Clinical	Medical/Clinical
Analog or Digital	Digital	Digital	Digital
ElectrodeConfiguration	3 or 5 wire: 7 vectordisplay	3 or 5 wire: 7 vectordisplay	3 or 5 wire: 7 vectordisplay
FrequencyResponse	Not Used	Not Used	Not Used
Input Impedance	Not Used	Not Used	Not Used
Dynamic Range	Not Used	Not Used	Not Used
Common ModeRejection Rate(CMMR)	Not Used	Not Used	Not Used
QRS DetectionSensitivity	AHA 99.87 MIT 99.95	AHA 99.88 MIT 99.93	AHA 99.18 MIT 99.51
Pacemaker PulseRejection	Not Used	Not Used	Not Used
System Noise	Arrhythmia NoiseDetection	Arrhythmia NoiseDetection	Arrhythmia NoiseDetection
Hard-wired and/orWireless	Both	Both	Both
Radio FrequencyTelemetry	Wireless 802.11 support	Wireless 802.11 support	455 to 465 MHz
Transtelephonicand/or FaxCapability	Technical Support RemoteDial Up	Technical SupportRemote Dial Up	Technical SupportRemote Dial Up
AlarmLevels/Mgmt.Standalone	Vital Signs, Arrhythmia,and ST Analysis	Vital Signs, Arrhythmia,and ST Analysis	Vital Signs, Arrhythmia,and ST Analysis
AlarmLevels/Mgmt.Connected/Linked	Vital Signs, Arrhythmia,and ST Analysis	Vital Signs, Arrhythmia,and ST Analysis	Vital Signs, Arrhythmia,and ST Analysis
Data Storage	96 hour Full Disclosure	96 hour Full Disclosure	96 hour Full Disclosure
Samples persecond - BitResolution	180 samples/sec fordisplay500 samples/sec for	180 samples/sec fordisplay500 samples/sec forarrhythmia	180 samples/sec fordisplay500 samples/sec forarrhythmia
	arrhythmia
	AHA	MIT
QRS Sensitivity	99.86	99.95
QRS Positive Predictivity	99.89	99.88
Ventricular Sensitivity	93.26	95.52
Ventricular Positive Predictivity	98.21	97.07

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Image /page/3/Picture/1 description: The image shows the logo for Welch Allyn. The text is in a bold, serif font. The logo is black and the background is white.

510(k) Summary - Acuity® Central Monitoring Station

Performance Data:

Conclusions:

The Acuity® Central Monitoring Station is as safe, as effective and performs as well as the legally marketed devices predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health. The seal is simple and monochromatic.

DEC 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Welch Allyn, Inc. c/o Mr. John E. Sawyer C/0 MIT John E. BanJa
Vice President, World Wide Regulatory Affairs 4341 State Street Road Skaneateles Falls, NY 13153-0220

Re: K052160

Trade Name: Acuity® Central Monitoring Station Regulation Number: 21 CFR 870.1025 Regulation Number: 21 CFR 8 70.1025
Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement
Programmand Arrhythmia Detector and Alarm (including ST and alarm) Regulatory Class: Class II (two) Product Code: DSI Dated: November 08, 2005 Received: November 15, 2005

Dear Mr. Sawyer:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 IQ(x) prematics is substantially equivalent (for the indications
referenced above and have determined the device marketed in interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drue commerce prior to May 28, 1976, the enactinent and of the Federal Food, Drug, devices that have been reclassified in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not required as assess as arrovisions of the Act. The and Cosmetic Act (Act) that do not require approval or a pell controls provisions of the Act. The
You may, therefore, market the device, subject to the emerge for emistrati You may, therefore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act merade requirement.
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 If your device is classified (see above) mio child cass if eperilations affecting your device can
may be subject to such additional controls. Existing major regulations affe may be subject to such additions. Existing may of the 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Regist be found in the Code of I cacral regarates, in the Federal Register.

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Page 2 – Mr. John E. Sawyer

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualice of a substance of the requirements of the Act
that FDA has made a determination that your device complies with other requires. You must that FDA has made a decemination and regulations administered by other Federal agencies. You must a or any Federal statures and regulations daministered or registration and listing (21)
comply with all the Act's requirements, including, but not limited to set comply with all the Act 3 requirements, me, and manufacturing practice requirements as setting CFR Part 807), labeling (21 CFR Part 800); god and 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 app 1000, 10 forth in the quality systems (Sections 531-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFF 1000-1050. product radiation control provisions (Declons 507 C vice as described in your Section 510(k)
This letter will allow you to begin marketing your device as described in your de I his letter will anow you to ocgin manxomis your antial equivalence of your device to a legally premarket nothcation. The PDA midning of substance results and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), please If you desire specific advice for your dones at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Comphalloo at (210) 276 - 11 - 11 807.97). You may obtain " Misorationing by reference to promantee nowlite as a carrest the Act from the Division of Small other general information on your responsionner at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Fissionality and corporation of the many in the support/index.html.

Sincerely yours,

B. Ammerman for

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

Enclosure

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WelchAllyn

Abbreviated 510(k) Premarket Notification Acuity® Central Monitoring Station

Statement of Indications for Use 1

KO58160 510(k) Number (if known):

Acuity® Central Monitoring Station Device Name:

Indications for Use:

The Acuity® Central Monitoring Station is intended to be used by clinicians for the The Acarey of neonatal, pediatric, and adult patients in health care facilities.

Full Disclosure stores patient data for up to 96 hours. .
Arrhythmia monitoring module provides real-time monitoring and alarms for specific . changes in cardiac rhythms. The clinician is responsible for determining the clinical eilance of each detected arrhythmia event or alarm. The arrhythmia module is not intended for use with neonatal patients.
ST analysis module provides real-time monitoring and alarms for ST segment . B r unalyons from a reference beat, for patients with suspected heart disease and avomalies. The clinician is responsible for determining the clinical significance of each selected ST segment deviation or alarm. The ST analysis module is not intended for use with neonatal patients.

(Part 21 CFR 801 Subpart D)	(Part 21 CFR 807 Subpart C)
-----------------------------	-----------------------------

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K052160

Section 1 – Page 1 of 1

AND/OR

MPD FCD-0025, Rev. 2

Prescription Use

This document contains information considered to be CONFIDENTIAL to Welch Allyn, Inc.

Over-The-Counter Use

DD 007 Cubnart

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.