The Automatic Analysis and Interpretation Software Library is intended for use by qualified medical professionals for the assessment of arrhythmias using historic ambulatory ECG data. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Hotter, Event Monitor, 12 lead ambulatory or resting ECG devices, or other similar devices when assessment of the rhythm is necessary. The Automatic Analysis and Interpretation Software Library can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as an ECG management system. The Automatic Analysis and Interpretation Software Library provides ECG signal processing and analysis on a beat by beat basis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis for up to sixteen(16) leads of captured data. The library is not for use in life supporting or sustaining systems or ECG monitoring and Alarm devices. The product can be integrated into computerized ECG monitoring devices. In this case the medical device manufacturer will identify the indication for use depending on the application of their device.

Device Description

The Monebo Automated ECG Analysis and Interpretation Software Library is an "object library". An object library is a collection of callable functions that have been complied (or assembled) into machine code or IDL code of the computer on which they execute. The Monebo Automated ECG Analysis and Interpretation Software Library consists of a basic application for viewing, analyzing and annotating ECG data, and a callable object library built on the Microsoft .Net framework. An application software program can be written to invoke some or all of the functions in an object library. The Monebo Automated ECG Analysis and Interpretation Software Library provides ECG signal processing, QRS detection and measurement of duration, QRS feature extraction, classification of Normal and Ventricular Ectopic beats, heart rate measurement, measurement of PR and QT intervals, and rhythm interpretation for up to 16 leads of captured ECG data. The library can be accessed through an Application Program Interface (API) as a callable function. This allows the library to be used as an accessory to an ECG management application or as a stand-alone product. Monebo will compile the Monebo Automated ECG Analysis and Interpretation Software Library specified by an ECG device manufacturer. An object library will be created and delivered to the device manufacturer, who can then integrate it into application software for their ECG analysis.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the Monebo Automated ECG Analysis and Interpretation Software Library, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the results achieved in comparison to established benchmarks (AHA, MIT-BIH, CSE databases) for QRS detection, ventricular ectopic beat (VEB) detection, heart rate, and various arrhythmia statements. The document doesn't explicitly state pass/fail thresholds for each metric but reports the device's performance against these recognized standards.

Bench Test Results (per ANSI/AAMI EC 57):

Summary results of AHA and MIT testing	QRS Se	QRS +P	VEB Se	VEB +P
AHA	99.56	99.9	82.49	95.65
MIT-BIH	99.45	99.45	87.03	87.76
NST	91.56	85.66	81.79	53.19

Bench Test Results (per IEC 60601-2-51 for CSE Database):
The table provided for the CSE database is incomplete and contains corrupted text, making it impossible to extract specific criteria and performance values for measurement accuracy (mean difference and standard deviation).

Arrhythmia Detection Accuracy (Overall MIT DB):

	Sensitivity	Specificity	Positive Predictive Accuracy	Negative Predictive Accuracy
Arrhythmia Detection (MIT DB)	96	97	73	97

Accuracy of Specific Arrhythmia Statements (MIT DB):

Arrhythmias	Sensitivity	Specificity	Positive Predictive Accuracy	Negative Predictive Accuracy
Normal sinus rhythm	100	100	95	100
PVC	100	100	86	100
APC	96	66	70	66
Atrial Fibrillation	100	100	77	100
Ventricular Tachycardia	75	89	60	89
Bradycardia	Insufficient data	96	Insufficient data	96
Tachycardia	Insufficient data	100	Insufficient data	100
AV block	57	87	26	87
BBB	77	88	25	88
Ventricular Trigeminy	50	84	100	84
Ventricular Bigeminy	81	93	81	93
AIVR	100	100	15	100
Pause	Insufficient data	Insufficient data	Insufficient data	Insufficient data

(CU DB - Ventricular Flutter):

Arrhythmias	Sensitivity	Specificity	Positive Predictive Accuracy	Negative Predictive Accuracy
Ventricular Flutter*	100	94	*	*
*Positive Predictive and Negative Predictive Accuracy cannot be calculated because all records contain VF.

Rhythm Accuracy (250 Annotated ECG Strips):

Rhythm	Sensitivity	Positive Predictivity	Specificity	False Positive Rate	Negative Predictivity
Normal sinus rhythm	91.18	100.00	100.00	0.00	96.81
Atrial fibrillation	90.91	80.00	95.15	4.85	98.00
Nodal rhythm	76.47	46.43	93.56	6.44	98.20
SVTA	100.00	61.90	92.86	7.14	100.00
Ventricular tachycardia	100.00	85.71	99.59	0.41	100.00
BBB	82.14	79.31	97.30	2.73	97.74
1st degree AV block	88.46	74.19	96.43	3.57	98.63
2nd degree AV block (Mobitz 1)	96.77	100.00	100.00	0.00	99.55
2nd degree AV block (Mobitz 2)	100.00	100.00	100.00	0.00	100.00
Complete AV block	96.77	100.00	100.00	0.00	99.55
Idioventricular rhythm	72.73	88.89	99.58	0.42	98.76
Sinus bradycardia	91.67	100.00	100.00	0.00	98.62
Sinus tachycardia	77.78	100.00	100.00	0.00	98.31
APC	77.50	65.26	80.59	19.41	88.39
PVC	89.55	73.17	87.98	12.02	95.83
Pause	96.88	73.81	94.95	5.05	99.52
Overall Performance	90.23	82.19	96.42	3.58	98.23

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

The document indicates the following for test sets:

AHA, MIT-BIH, NST (likely part of MIT-BIH): Standard databases used for benchmarking. The specific number of records/patients from these databases is not provided, but these are well-known, publicly available, and diverse datasets.
- Provenance: These are international, publicly available retrospective databases.
CSE Database: Standard database used for benchmarking.
- Provenance: This is an international, publicly available retrospective database.
MIT DB Arrhythmia Statements: Specific sections provide sensitivity, specificity, and predictive values for various arrhythmias using the MIT-BIH database.
- Provenance: International, publicly available retrospective database.
250 Annotated ECG Strips: Used for detailed rhythm classification metrics.
- Provenance: "renorded by various event recorders". The country of origin is not specified, nor is whether it's retrospective or prospective, but it implies a collection of real-world patient data.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for any of the databases (AHA, MIT-BIH, CSE, or the 250 ECG strips). It relies on the pre-established annotations of these benchmark databases, which are generally considered expert-annotated.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test sets. It relies on the existing annotations within the standard databases.

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

No MRMC comparative effectiveness study is mentioned in the document. The study evaluates the standalone performance of the algorithm against established ground truths, not its impact on human reader performance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The entire "Test Results" section (K062282, pg 2 and 3) details the performance of the "Monebo Automated ECG Analysis and Interpretation Software Library" in identifying QRS complexes, VEBs, and various arrhythmias against established benchmark databases (AHA, MIT-BIH, CSE) and a set of 250 annotated ECG strips. This directly measures the algorithm's performance without human intervention.

7. Type of Ground Truth Used

The ground truth used for the studies appears to be expert consensus annotations as provided within the standard benchmark databases (AHA, MIT-BIH, CSE) and the "250 annotated ECG strips." These databases are conventionally annotated by electrophysiologists or cardiologists based on visual inspection and established diagnostic criteria. The document does not mention pathology or outcomes data as ground truth.

8. Sample Size for the Training Set

The document does not specify the sample size or details about any training set used for the algorithm. The provided information focuses entirely on the validation and testing of the final algorithm's performance on external datasets.

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

Since no information about a training set is provided, there is no detail on how its ground truth was established.

Summary

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K0622282
pg 1 of 4

510(k) Summary of Safety and Effectiveness

510(k) Notification Date: August 4, 2006 January 3, 2007 Revised March 6, 2007 Revised

MAR 2 2 2007

Submitter: Monebo Technologies, Inc. 1800 Barton Creek Blvd Austin, Texas 78735-1606

Contact Person: Dale J. Misczvnski Phone: 512-732-0235 512-732-0285 Fax: Email: dale.misczynski@monebo.com

Trade/Device Name: Monebo Automated ECG Analysis and Interpretation Software Library, Version 3.0 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS

Level of Concern Statement

The Monebo Automated ECG Analysis and Interpretation Software Library is a Moderate Level of Concern Software Device.

The library is intended for use with ECG management software which is a Moderate Level of Concern software device.

The library is not for use in life supporting or sustaining systems or ECG monitoring and Alarm devices.

A latent design flaw, failure or malfunction of the software, which were not revealed during the validation, verification and testing process, is possible over the life of the product. The results could result in a delayed response of appropriate medical care that would lead to injury or further diagnostic evaluations. The intended end users of the ECG analysis information are trained medical professional who are responsible for reviewing the device output and rendering the final diagnostic or treatment decision.

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K062282
Pg 2 of 4

Predicate Devices:

The Monebo Automatic Arrhythmia Detection Software Library, Agilent and Brentwood predicates are software only devices that monitor cardiac function. Table 1 compares the features of the Monebo Automated ECG Analysis and Interpretation Software Library to predicate devices.

Feature	MoneboAutomatedECGAnalysis andInterpretationSoftwareLibrary	MoneboAutomaticArrhythmiaDetectionSoftwareLibrary510(k)K043380	Agilent510(k)K003621	Brentwood510(k)K013717
Heart rate determination fornon-paced adult	YES	NO	YES	YES
QRS Detection	YES	YES	YES	YES
Non-paced arrhythmiainterpretation for adultpatients	YES	NO	YES	YES
Non-paced ventriculararrhythmia calls for adultpatients	YES	YES	YES	YES
Intervals measurement	YES	NO	YES	YES
Ventricular ectopic beatdetection	YES	YES	YES	YES
Patient Populations	Adult	Adult	Adults,Pediatric,Neonatal	Adult

Test Results

The bench test results of the software using AHA and MIT-BIH databases per ANSI/AAMI EC 57 are shown in the table below:

Summary results of AHA and MIT testing
Database	QRS Se	QRS +P	VEB Se	VEB +P
AHA	99.56	99.9	82.49	95.65
MIT-BIH	99.45	99.45	87.03	87.76
NST	91.56	85.66	81.79	53.19

The bench test results of the software using CSE database per IEC 60601-2-51 are shown in the tables below:

Summary results of CSE DB testing
Measurement	AcceptableMean difference	Acceptablestandarddeviation	Monebo meandifference	Monebo standarddeviation

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K062282
pg 3 of 4

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Summary results of MIT DB arrhythmia statement testing:

Accuracy of Arrhythmia Detection
Sensitivity	Specificity	Positive PredictiveAccuracy	Negative PredictiveAccuracy
96	97	73	97
Arrhythmias: Normal sinus rhythm, Sinus Bradycardia, Sinus Tachycardia, PVC, APC, Atrial Fibrillation,Ventricular Tachycardia, Ventricular Flutter, Sinus Tachycardia, Pause (Asystole), AV block, BBB,Ventricular trigeminy, Ventricular Bigeminy, AIVR

Accuracy of Arrhythmia Statements
Arrhythmias	Sensitivity	Specificity	PositivePredictiveAccuracy	NegativePredictiveAccuracy
MIT DB
Normal sinusrhythm	100	100	95	100
PVC	100	100	86	100
APC	96	66	70	66
Atrial Fibrillation	100	100	77	100
VentricularTachycardia	75	89	60	89
Bradycardia	Insufficient data	96	Insufficient data	96
Tachycardia	Insufficient data	100	Insufficient data	100
AV block	57	87	26	87
BBB	77	88	25	88
VentricularTrigeminy	50	84	100	84
VentricularBigeminy	81	93	81	93
AIVR	100	100	15	100
Pause	Insufficient data	Insufficient data	Insufficient data	Insufficient data
CU DB
VentricularFlutter*	100	94	*	*
* Positive Predictive and Negative Predictive Accuracy cannot be calculated because all records contain VF

The results covering Sensitivity, Positive Predictivity, Specificity, False Positive Rate, and Negative Predictivity and which are based on a database of 250 annotated ECG strips, renorded by various event recorders are in the table below.

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Rhythm	Sensitivity	PositivePredictivity	Specificity	FalsePositiveRate	NegativePredictivity
	Se	+P	Sp	FPR	-P
Normal sinus rhythm	91.18	100.00	100.00	0.00	96.81
Atrial fibrillation	90.91	80.00	95.15	4.85	98.00
Nodal rhythm	76.47	46.43	93.56	6.44	98.20
SVTA	100.00	61.90	92.86	7.14	100.00
Ventricular tachycardia	100.00	85.71	99.59	0.41	100.00
BBB	82.14	79.31	97.30	2.73	97.74
1st degree AV block	88.46	74.19	96.43	3.57	98.63
2nd degree AV block(Mobitz 1)	96.77	100.00	100.00	0.00	99.55
2nd degree AV block(Mobitz 2)	100.00	100.00	100.00	0.00	100.00
Complete AV block	96.77	100.00	100.00	0.00	99.55
Idioventricular rhythm	72.73	88.89	99.58	0.42	98.76
Sinus bradycardia	91.67	100.00	100.00	0.00	98.62
Sinus tachycardia	77.78	100.00	100.00	0.00	98.31
APC	77.50	65.26	80.59	19.41	88.39
PVC	89.55	73.17	87.98	12.02	95.83
Pause	96.88	73.81	94.95	5.05	99.52
Overall Performance	90.23	82.19	96.42	3.58	98.23

Device Description:

The Monebo Automated ECG Analysis and Interpretation Software Library provides ECG signal processing, QRS detection and measurement of duration, QRS feature extraction, classification of Normal and Ventricular Ectopic beats, heart rate measurement, measurement of PR and QT intervals, and rhythm interpretation for up to 16 leads of captured ECG data.

The library can be accessed through an Application Program Interface (API) as a callable function. This allows the library to be used as an accessory to an ECG management application or as a stand-alone product.

Monebo will compile the Monebo Automated ECG Analysis and Interpretation Software Library specified by an ECG device manufacturer. An object library will be created and delivered to the device manufacturer, who can then integrate it into application software for their ECG analysis.

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

APR 2 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Monebo Technologies Inc. c/o Mr. Dale Misczynski 1800 Barton Creek Blvd Austin, TX 78735

Re: K062282

Trade/Device Name: Monebo Automated ECG Analysis and Interpretation Software Library Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: March 6, 2007 Received: March 7, 2007

Dear Mr. Misczynski:

This letter corrects our substantially equivalent letter of March 22, 2007.

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 (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 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. Misczynski

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 continue 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/dsma/dsmamain.html

Sincerely yours,

B.J. Zimmerman fa

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: K062282

Device Name: Monebo Automatic ECG Analysis and Interpretation Software Library

Indications for Use:

The product can be integrated into computerized ECG monitoring devices. In this case the medical device manufacturer will identify the indication for use depending on the application of their device.

Prescription Use V

AND/OR

1000 1000 Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumimmo

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).