AlertWatch:OR is intended for use by clinicians for secondary monitoring of patients within operating rooms. AlertWatch:OR combines data from networked physiologic monitors, anesthesia information management medical records and displays them in one place. AlertWatch:OR can only be used with both physiological monitors and AIMS versions that have been validated by AlertWatch. Once alerted, you must refer to the primary monitor or device before making a clinical decision.

Device Description

AlertWatch:OR is a display and secondary alert system used by the anesthesiology staff - residents, CRNA's, and attending anesthesiologists - to monitor patients in operating rooms. The purpose of the program is to synthesize a wide range of patient data and inform clinicians of potential problems that might lead to immediate or long-term complications. Once alerted, the clinician is instructed to refer to the primary monitoring device before making a clinical decision. AlertWatch:OR should only be connected to AIMS systems and physiologic monitors that have been validated for use with Alert Watch:OR. Alert Watch, Inc. performs the validation for each installation site.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the AlertWatch:OR device, based on the provided document:

The document does not explicitly state formal acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds). Instead, the performance testing section describes verification and validation activities designed to ensure the product works as designed, meets its stated requirements, and is clinically useful.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria (e.g., sensitivity > X%, specificity > Y%) are not provided, the table below reflects the described performance testing outcomes.

Acceptance Criterion (Implicit from Study Design)	Reported Device Performance (from "Performance Testing" section)
Verification: Analysis Output Accuracy	Produced desired output for each rule/algorithm using constructed data.
Verification: Data Display Accuracy	Produced desired display for each test case using constructed data.
Verification: Data Collector Functionality	Live Collector and Data Collector returned correct data from the EMR.
Verification: Product Functionality with Historical Data	Product worked as designed using a set of cases from actual patients.
Validation: Design Review & Software Requirements Specification (SRS) Accuracy	Process and various inputs for creating the product design (SRS) were reviewed. SRS was reviewed for clinical accuracy.
Validation: Clinical Utility	Clinical utility of the product was validated by analyzing case outcomes.
Validation: Human Factors	Summative Human Factors study conducted to demonstrate the device meets user needs.
Overall Performance Claim	The results of the verification and validation activities demonstrate that the AlertWatch:OR complies with its stated requirements and meets user needs and intended uses.

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

Sample Size for Verification (Step 4: Historical Data): "a set of cases from actual patients" - The exact number of cases is not specified.
Data Provenance: "data from the EMR" and "a set of cases from actual patients." The document does not specify the country of origin, nor explicitly whether it was retrospective or prospective, though "historical data" strongly implies retrospective data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth, and it does not explicitly describe a ground truth establishment process involving experts in the traditional sense (e.g., for diagnostic accuracy). The "clinical accuracy" review of the software requirements specification implies expert involvement, but details are missing.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (such as 2+1, 3+1) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study focused on the device's functionality and utility rather than a direct comparison of human readers with and without AI assistance to quantify improvement.

6. Standalone (Algorithm Only) Performance Study

The verification steps, particularly "Verify the analysis output" and "Verify the data display" using "constructed data," and "Verify the product with historical data," indicate that the algorithm's performance was evaluated in a standalone manner (without human-in-the-loop) to ensure it performs "as designed" and produces "desired output/display." However, these are functional verifications rather than a typical standalone diagnostic performance study with metrics like sensitivity, specificity, or PPV/NPV.

7. Type of Ground Truth Used

The ground truth for the performance testing appears to be established by:

"Desired output" based on the "Software Requirements Specification" for constructed data tests (functional verification).
"Works as designed" when tested with "a set of cases from actual patients" (implies comparison to expected system behavior based on its design, rather than a clinical outcome or expert diagnosis acting as a gold standard).
"Clinical utility... by analyzing case outcomes" suggests that real-world patient outcomes were used to assess the value of the alerts generated. This hints at an outcome-based ground truth for the validation of clinical utility, but details are scarce.

8. Sample Size for the Training Set

The document does not specify the sample size for a training set. The descriptions of verification and validation do not refer to machine learning model training. The device seems to operate based on "rules/algorithms in the Software Requirements Specification" rather than a trained AI model.

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

As there's no mention of a dedicated training set or a machine learning model requiring such, this information is not applicable based on the provided text. The device likely relies on predefined rules and algorithms.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

February 7, 2014

AlertWatch LLC c/o Donna-Bea Tillman 400 N. Washington Street Suite 100 Alexandria, VA 22314 US

K130401 Re:

Trade/Device Name: Alertwatch: OR Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor (with Arrhythmia Detection or Alarms) Regulatory Class: Class II Product Code: MHX Dated: November 6, 2013 Received: November 8, 2013

Dear Ms. Donna-Bea Tillman:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 comply with all the Act's requirements, including, but not limited to: registration and listing (2 I CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Donna-Bea Tillman

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.zov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), piease go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Owen P. Faris -S

for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K130401

Device Name

AlertWatch:OR

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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K130401 AlertWatch: OR

510(k) Summary

In accordance with 21 CFR 807.87(h) and (2) CFR 807.92) the 510(k) Summary for the AlertWatch:OR device is provided below.

Device Common Name:	Physiological Patient Monitor with arrhythmia detection or alarms
Device Proprietary Name:	AlertWatch:OR
Submitter:	AlertWatch1600 Huron Pkwy, Bldg. 520, Ste. 2326Ann Arbor, MI 48109
Contact:	Donna-Bea TillmanSenior ConsultantBiologics Consulting Group, Inc.Phone: 410-531-6542Fax: 720-293-0014Email: dtillman@bcg-usa.com
Date Prepared:	January 30, 2014
ClassificationRegulation:	21 CFR 870.1025
Panel:	Cardiovascular
Product Code:	MHX
Predicate Device:	K082583, Phillips MP90

Indication for Use:

Alert Watch:OR is intended for use by clinicians for secondary monitoring of patients within operating rooms. AlertWatch:OR combines data from networked physiologic monitors, anesthesia information management systems and patient medical records and displays them in one place. AlertWatch:OR can only be used with both physiological monitors and AIMS versions that have been validated by AlertWatch. Once alerted, you must refer to the primary monitor or device before making a clinical decision.

Device Description:

Device Deseription.
AlertWatch:OR is a display and secondary alert system used by the anesthesiology staff - residents, CRNA's, and attending anesthesiologists - to monitor patients in operating rooms. The purpose of the program is to synthesize a wide range of patient data and inform clinicians of potential problems that

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K130401 AlertWatch: OR

might lead to immediate or long-term complications. Once alerted, the clinician is instructed to refer to the primary monitoring device before making a clinical decision. AlertWatch:OR should only be connected to AIMS systems and physiologic monitors that have been validated for use with Alert Watch:OR. Alert Watch, Inc. performs the validation for each installation site.

Performance Testing:

Verification of AlertWatch:OR was conducted to ensure that the product works as designed, and was tested with both constructed data and data from the EMR. There were four parts to the verification process:

I. Verify the analysis output: Using constructed data, each of the rules/algorithms in the Software Requirements Specification were passed to the product's analysis component to determine that it produced the desired output.
1. Verify the data display: Similar to step 1. Using constructed data, verify that the web client produced the desired display for each of the test cases.
1. Verify the collectors: Determine that the Live Collector and the Data Collector return the correct data from the EMR.
1. Verify the product with historical data: Using a set of cases from actual patients, determine that the product works as designed.

Validation was conducted to check the design and performance of the product, and included these steps:

Review the process and various inputs for creating the product design the software requirements specification.
1. Review the software requirements specification for clinical accuracy.
1. Validate the clinical utility of the product by analyzing case outcomes.
1. Conduct a summative Human Factors study to demonstrate that the device meets user needs.

Substantial Equivalence:

The results of the verification and validation activities demonstrate that the AlertWatch:OR complies with its stated requirements and meets user needs and intended uses. Therefore, it can be found substantially equivalent to the MP90.

Table 1: Device Comparison Table

	Proposed Device	Predicate Device
Device Name	AlertWatch:OR	Philips MP90
510(k) number	Not Yet Assigned	K082583
Classification	MHX	MHX
Regulation	870.1025	870.1025
Indications forUse	AlertWatch: OR is intended for useby clinicians for secondary	Indicated for use by health careprofessionals whenever there is a
	monitoring of patients withinoperating rooms.AlertWatch:OR accomplishes thisby aggregating data from networkedphysiologic monitors, anesthesiainformation management systemsand patient medical records anddisplaying them at a central location.Once alerted, the clinician must referto the primary monitoring devicebefore making a clinical decision.	need for monitoring thephysiological parameters ofpatients. Intended for monitoringand recording of and to generatealarms for multiple physiologicalparameters of adults, pediatrics andneonates in hospital environments.The MP2, X2, MPS, MP20, MP30,MP40, and MPSO are additionallyintended for use in transportsituations within hospitalenvironments. The MP2, X2 andMPS are also intended for useduring patient transport outside of ahospital environment.
Intended Useenvironment	OR	OR, Bedside
Intended Users	Anesthesiologist, CRNA	Anesthesiologist, Surgeon,Perfusionist
Data server	AlertWatch:OR accessesphysiologic data from the hospitalnetwork, and all other data from theAIMS database server.	Philips IntelliVue ApplicationServer accesses information fromthe hospital network, includingradiology, pharmacy, laboratory andHospital Information System data.
Re-display ofvital sign datafrom primarymonitors	Yes	Yes
Generatesclinicaladvisories	AlertWatch:OR Alerts analyzes datafrom patient monitors and othersources and alerts when valuesexceed preset limits.	Advanced Event Surveillancefeature analyzes data from patientmonitors and alerts when valuesexceed preset limits.
Uses color todisplay clinicalinformation	Image: Diagram of a body with different colored regions	Image: Screenshot of a monitor displaying vital signs
Intended toreplaceprimarymonitors	No	No

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K130401 AlertWatch: OR

3 of 3

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.