The TruVue™ System is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia.
Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath)
Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring
ECG data recorded by the device can be analyzed by other processing systems, such as the BMS Century Holter system to provide Holter style reports

Device Description

The TruVue™ system is a continuous ECG monitor and Arrhythmia detector. The system is comprised of a body worn sensor that collects, stores and transmits 2 channels of ECG, a handheld communications device that transmits the ECG to an attended monitoring center and analysis software that continuously analyzes the ECG signal for arrhythmia.

The sensor communicates with the handheld over a Bluetooth link, the handheld communicates with the data center over the cellular telephony network or a land line telephony network. Full disclosure ECG is available at the data center for use by the analysis algorithm or for review and further analysis by a monitoring technician or physician.

AI/ML Overview

The provided 510(k) summary for the TruVue™ System (K100155) does not contain a detailed study with acceptance criteria and reported device performance metrics in the way modern AI/ML device submissions typically do.

This submission from 2010 focuses heavily on substantial equivalence to predicate devices. The "performance validation" mentioned in section 7 ("Conclusions") is likely referring to the device's adherence to relevant performance standards like AAMI EC 38 and ANSVAAMI-EC 57, rather than a specific clinical study with granular performance metrics for arrhythmia detection that would be found in a standalone algorithm study.

Therefore, many of the requested fields cannot be directly extracted from this document. I will fill in what can be inferred or directly stated, and clearly mark what information is not present.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric/Acceptance Criteria	Reported Device Performance
Ambulatory ECG Performance (Compliance to EC 38)	EC 38 compliant (stated as substantial equivalence to predicate devices)
Performance of Cardiac Rhythm and ST Segment Measurement Algorithms (Compliance to ANSVAAMI-EC 57)	Implied compliance through referencing the standard, but no specific metrics are reported.
Arrhythmia Detection Accuracy (Sensitivity, Specificity, etc.)	Not reported in this document. The document states it has an "analysis algorithm that continuously analyzes the ECG signal for arrhythmia" but provides no performance metrics.
Equivalence to predicate devices in function	Stated as "substantially equivalent" for various features (ECG channels, ambulatory performance, acquisition/WAN, transmission technology, user event trigger, algorithm).

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

Sample Size (Test Set): Not specified.
Data Provenance: Not specified. (The document mentions the device transmits data to a monitoring center, but doesn't detail any specific dataset used for validation beyond adherence to standards).
Retrospective or Prospective: Not specified.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document states "Full disclosure ECG is available at the data center for use by the analysis algorithm or for review and further analysis by a monitoring technician or physician," but doesn't describe expert review for ground truth establishment in a testing context.

4. Adjudication method for the test set

Adjudication Method: Not specified.

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: Not indicated. This type of study is more common for imaging AI devices. The TruVue™ System is an "Arrhythmia Detector and Alarm," and its "analysis algorithm" would likely be evaluated in a standalone performance study rather than a reader study in the context of this 2010 submission.
Effect Size: Not applicable/Not reported.

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

Standalone Study: The document implies a standalone algorithm, as it describes "analysis software that continuously analyzes the ECG signal for arrhythmia." However, it does not present specific data from a standalone performance study in terms of metrics like sensitivity, specificity, or PPV/NPV for various arrhythmias. Instead, it relies on compliance with standards (AAMI EC 38, ANSVAAMI-EC 57) for performance validation.

7. The type of ground truth used

Type of Ground Truth: Not explicitly stated. For a device like this, ground truth would typically be established through expert cardiological review of the full disclosure ECG data (potentially with additional clinical information), but the document does not detail this.

8. The sample size for the training set

Training Set Sample Size: Not specified. The document describes a "Proprietary / Server side" algorithm but provides no details about its development or training.

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

Ground Truth Establishment (Training Set): Not specified.

Summary Limitations:

This 510(k) summary provides very limited information regarding detailed performance studies with acceptance criteria, ground truth, and statistical metrics. This is characteristic of older 510(k) submissions, particularly for devices seeking substantial equivalence where performance is often demonstrated through adherence to recognized standards and comparison to previously cleared devices rather than extensive clinical performance trials with granular data. The focus is on demonstrating that the device is "as safe and effective as its predicates."

Summary

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K100155
pi/3

510(k) Summary of Safety & Effectiveness	Date: Jan 14, 2010
1.) Submitter Name & Address:	Biomedical Systems, Inc77 Progress ParkwayMaryland Heights, MO 63043	APR 20 2010
2.) Contact Person:	K. Michael KroehnkePhone: 314-576-6800Fax: 877-581-7858
3) Device:
Trade Name:	TruVue™ System
Classification Name	Arrhythmia Detector and Alarm
Product Code:	DSI
Regulation No:	870.1025
Class:	Class II, Special Controls
4) Substantial Equivalence:

The TruVue™ System is substantially equivalent to following previously cleared devices:

1. CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector, K081257
1. NUVANT, Mobile Cardiac Telemetry System, K091971

Medicalgorithmics Real-Time ECG Monitor and Arrhythmia Detector, K090037

	TruVue™	CG-6108ACT-3L	PocketECG	NUVANT	SEDetermination
ECG Channels	2	2	1	1	SE, see note a
AmbulatoryECGperformancestandards	EC 38compliant	EC 38compliant	EC 38compliant	EC 38compliant	SE, see note b
ECGAcquisition /WANcommunications	Body wornsensor,handheldWANdevice	Body wornsensor,handheldWANdevice	Body wornsensor,handheldWANdevice	Body wornsensor,handheldWANdevice	SE

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TransmissionTechnology(PAN)	Bluetooth	Bluetooth	Bluetooth	Bluetooth	SE
TransmissionTechnology(WAN)	CellularPOTSModem	CellularPOTSModem	Cellular	Cellular	SE, see note c
User EventTrigger	HandhelduserInterface	HandheldUserInterface	HandheldUserInterface	PatientMagnet	SE, see note d
Algorithm	Proprietary/ Serverside	Proprietary/ Deviceside	Proprietary/ Device side	Proprietary/ Deviceside	SE, see note e

a) All predicates devices provide at least one channel of ECG, the minimum requirement cited in AAMI-EC38 for ambulatory arrhythmia monitoring.
b) All predicate devices meet the ECG performance requirements (or claim SE to a predicate device that meets the performance requirements) of AAMI EC-38 and are therefore SE.
c) All predicate devices use public communication networks for transmission of data to a monitoring center, whether cellular, POTS, or both and are therefore SE.
d) All predicate devices have a means for the patient to indicate a symptomatic event and are therefore SE.
e) All predicate devices contain an analysis algorithm with SE capabilities between the signal acquisition point and the reviewer of the data and are therefore SE.

5) Device Description

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6) Indications for use

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

Indications:

1. The TruVue System is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia.
Patients who require monitoring of effect of drugs to control ventricular rate 2. in various atrial arrhythmias (e.g. atrial fibrillation)
1. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath)
1. Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring
1. ECG data recorded by the device can be analyzed by other processing systems, such as the BMS Century Holter system to provide Holter style reports

Contraindications

The TruVue System is contraindicated for those patients requiring attended, Inhospital monitoring for life threatening arrhythmias.

Note

The TruVue system does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician.

7) Conclusions

The TruVue system has the same intended use, similar operating principles and similar technological characteristics as the predicate devices. As supported by the describtive information and performance validation it is concluded that the TruVye system.ip as safe and effective as its predicates.

8) Referenced standards

FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm

-IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety

-IEC 60601-1-2 Medical Electrical Equipment -- Part 1: General Requirements for Safety; Electromagnetic Compatibility

-AAMI EC 38-2007, Ambulatory Electrocardiographs

-ANSVAAMI-EC 57:1998, Testing and Reporting - Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Biomedical Systems Corporation c/o Mr. K. Michael Kroehnke Director of Quality Management 77 Progress Parkway St. Louis, MO 63043

APR 2 0 2010

K100155 Re:

Trade/Device Name: TruVue™ Wireless Ambulatory ECG Regulatory Number: 21 CFR 870.1025 Regulation Name: Detector and Alarm, Arrhythmia · Regulatory Class: II (two) Product Code: 74 DSI Dated: March 18, 2010 Received: March 19, 2010

Dear Mr. Kroehnke:

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. Insting 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.

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Page 2 -- Mr. K. Michael Kroehnke

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); 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 (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 1

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/CDRHQffices/ucm115809.htm 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 Part 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/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/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

510(k) Number (if known):

Device Name:_TruVue™ Wireless Ambulatory ECG

Indications For Use:

1. The TruVue™ System is intended for use by patients who experience transient events that may suggest cardiac arrhythmia
Patients who require monitoring of effect of drugs to control ventricular rate in various atrial 2. arrhythmias (e.g. atrial fibrillation)
1. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath)
1. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring.
1. ECG data recorded by the device can be analyzed by other processing systems, such as the BMS Century Holter system to provide Holter style reports

Contraindications:

The TruVue™ System is contraindicated for those patients requiring attended, In-hospital monitoring for life threatening arrhythmias.

Note: The TruVue™ System does not provide interpretive statements. Interpretation and diagnosis is the responsibility of the physician.

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

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)

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(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number	K100155
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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.