The intended user is a medical device manufacturer who will integrate the ST/AR Library into a computerized cardiac monitoring device. The ST/AR Library integrator will ultimately identify the indications for use, depending on the nature of their device.

The analysis capabilities of the ST/AR Library are indicated for monitoring and detecting the following from up to 12 body surface ECG leads for adult, pediatric, or neonatal patients:

QRS detection
ventricular ectopic beat detection (non-paced only)
rhythm call analysis, including asystole, bigeminy, couplets, irregular heart rate, pause or missed beat, VEB/minute, run, trigeminy, triplets, ventricular tachycardia
ST segment level measurement (adult patients only)
ventricular fibrillation detection

Device Description

The Brentwood Real Time ST and Arrhythmia Analysis Software Library is an "object library'. An object library is a collection of callable functions that have been compiled (or assembled) into the native machine code of the computer on which they will execute. An application software program can be written to invoke some or all of the functions in an object library. The compiled (or assembled) application code can be "linked" to the called functions from an object library at the time the executable code image is built. An executable code image created in this manner will contain the application software code and all of the functions it invoked from the object library.

The Brentwood Real Time ST and Arrhythmia Analysis Software Library consists of a collection of ANSI Standard C (ISO/IEC 9899) callable functions. It provides real time ECG signal processing, QRS detection, QRS complex feature extraction, ventricular ectopic beat detection, ST level measurement, rhythm calls, and ventricular fibrillation detection capabilities for up to 12 leads of captured ECG lead data.

Brentwood will compile the Brentwood Real Time ST and Arrhythmia Analysis Software Library using the compiler specified by an ECG analysis device manufacturer. An object library will be created and delivered to the manufacturer, who can then integrate it into application software for their ECG analysis device(s).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that performance testing was conducted in accordance with ANSI/AAMI EC57:1998. This standard defines the acceptance criteria for these types of measurements. While the specific numerical acceptance criteria for each metric (e.g., QRS detection sensitivity/specificity, heart rate accuracy, VEB detection accuracy) are not explicitly stated in the provided text, the document implies that the device met these criteria by stating "The following testing was performed in accordance with ANSI/AAMI EC57:1998 to evaluate the performance of the Brentwood Real Time ST and Arrhythmia Analysis Software Library." and subsequently receiving FDA clearance.

Acceptance Criteria (Based on ANSI/AAMI EC57:1998 - Specific values not provided in text)	Reported Device Performance (Implied by FDA Clearance)
Accuracy of QRS detection	Meets ANSI/AAMI EC57:1998 standards
Accuracy of heart rate measurement	Meets ANSI/AAMI EC57:1998 standards
Accuracy of VEB detection	Meets ANSI/AAMI EC57:1998 standards
Accuracy of ventricular fibrillation detection	Meets ANSI/AAMI EC57:1998 standards
Accuracy of ST segment analysis	Meets ANSI/AAMI EC57:1998 standards

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

Sample Size for Test Set: Not explicitly stated as a number of patients or recordings. However, the study used the following standard databases:
- AHA (American Heart Association) database
- MIT-BIH Arrhythmia Database
- NST (noise stress test) database
- CU (Creighton University) database (for ventricular fibrillation specifically)
- ESC (European Society of Cardiology) database (for ST segment analysis specifically)
Data Provenance: Retrospective, as standard, publicly available databases (AHA, MIT-BIH, NST, CU, ESC) were utilized. The country of origin of these databases is generally international, with MIT-BIH being U.S.-based.

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

Number of Experts: Not specified in the provided text.
Qualifications of Experts: Not specified in the provided text. However, for established standard databases like MIT-BIH and AHA, the ground truth annotations are typically performed by experienced cardiologists or electrophysiologists.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified in the provided text. For established standard databases, the ground truth may have been generated through consensus or a "gold standard" based on expert review.

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

MRMC Study: No, an MRMC comparative effectiveness study was not performed. The testing focused on the standalone performance of the software library against established databases, not on comparing human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Yes, a standalone performance evaluation was done. The entire performance testing section describes the evaluation of the "Brentwood Real Time ST and Arrhythmia Analysis Software Library" against standardized databases, focusing solely on the algorithm's capabilities.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth was based on expert annotations and established reference points within the standard databases (AHA, MIT-BIH, NST, CU, ESC). This can be classified as expert consensus/annotation-based ground truth, as these databases are meticulously reviewed and annotated by specialists.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not specified in the provided text. The document describes a "software library" that provides functions, implying it might be a predefined algorithm or model rather than something that was "trained" in the modern machine learning sense using a specific training set. If it was trained, the details are not provided.

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

Ground Truth for Training Set: Not specified. As mentioned above, it's unclear if a traditional "training set" with established ground truth was used in the modern machine learning context for this software library. If it was, the method for establishing ground truth is not provided.

Summary

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FEB 0 6 2002

This 510(k) Summary is prepared in accordance with 21 CFR 807.92.

1. BASIC INFORMATION

1.1 SUBMITTER

Name:	Brentwood Medical Technology Corp
Address:	3300 Fujita StreetTorrance, CA 90505
Contact Person:	Ruomei Zhang, PhD
Phone Number:	(310) 530-5955 x7210

November 6, 2001 Preparation Date:

1.2 DEVICE NAME

The name of the device is the Brentwood Real Time ST and Arrhythmia Analysis Software Library.

The classification name is "Arrhythmia detector and alarm".

The common/usual name is "Patient Monitor".

1.3 IDENTIFICATION OF LEGALLY MARKETED DEVICE

Substantial equivalence is claimed to a legally marketed device cleared under the name, "ST/AR ST and Arrhythmia Software, Release D.0". The registered manufacturer of the cleared device is Agilent Technologies, Inc. of Andover, MA, and the 510(k) number is K003621.

1.4 DEVICE DESCRIPTION

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1.5 INTENDED USE

The intended user of the Brentwood Real Time ST and Arrhythmia Analysis Software Library user is a medical device manufacturer who will integrate it into a computerized device that analyzes ECG signals captured from the human body surface. The library will provide the device with real time ECG signal processing, QRS detection, QRS complex feature extraction, ventricular ectopic beat detection, ST level measurement, rhythm calls, and ventricular fibrillation detection capabilities. The intended user is expected to label the device for use only by or under the supervision of a trained physician. The intended user is further assumed to have a quality system for developing and implementing software. The quality system should call for validating software, including the use of purchased software.

1.6 COMPARISON TO CLEARED DEVICE

Both the Brentwood Real Time ST and Arrhythmia Analysis Software Library and the predicate are software only devices that monitor cardiac function. Table 1 compares the features of the Brentwood device to the predicate.

Feature	Agilent	Brentwood
heart rate determination for (paced and non-paced) adult,pediatric, and neonatal patients	yes	yes
(non-paced) ventricular arrhythmia calls for adult, pediatric, andneonatal patients	yes	yes
(non-paced) ST segment level measurement for adult patients	yes	yes
(non-paced) ventricular ectopic beat detection	yes	yes

Table 1: Comparison of Brentwood's ST/AR Library to Predicate Device

2. PERFORMANCE TESTING

The following testing was performed in accordance with ANSI/AAMI EC57:1998 to evaluate the performance of the Brentwood Real Time ST and Arrhythmia Analysis Software Library. Unless otherwise noted, all testing used the AHA, MIT-BIH, and NST standard databases:

. accuracy of ORS detection.
accuracy of heart rate measurement, ●
accuracy of VEB detection,
ventricular fibrillation (also CU database), .
. ST segment analysis (ESC database only)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three lines extending from the head, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 6 2002

Ruomei Zhang, Ph.D. Chief Technical Officer Brentwood Medical Technology Corp. 3300 Fujita Street Torrance, CA 90505

Re: K013717

Trade Name: Brentwood Real Time ST and Arrhythmia Analysis Software Library (ST/AR Library) Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: November 6, 2001 Received: November 8, 2001

Dear Dr. Zhang:

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 - Ruomei Zhang, Ph.D.

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 or any I 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 Of A rat 007); accems (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) I mis lotter will and in yourse 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the O intor goneral into.itamos turers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Deatull

am D. Zuci л В kerman. M.D Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510 (k) Number (if known)

K013717

Brentwood Real-Time ST and Arrhythmia Analysis Software Library Device Name (referred to as the ST/AR Library).

Indications for Use

The intended user is a medical device manufacturer who will integrate the ST/AR Library into a computerized cardiac monitoring device. The BT71X Blorary integrator will ultimately identify the indications for use, depending on the nature of their device.

The analysis capabilities of the ST/AR Library are indicated for monitoring and detecting the following from up to 12 body surface ECG leads for adult, pediatric, or neonatal patients:

QRS detection .
ventricular ectopic beat detection (non-paced only) .
rhythm call analysis, including asystole, bigeminy, couplets, . irregular heart rate, pause or missed beat, VEB/minute, run, trigeminy, triplets, ventricular tachycardia
ST segment level measurement (adult patients only) .
ventricular fibrillation detection .

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE TO ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K013717

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).