The ECHO-COM for MS-Windows Version 2.0 cardiac software program is recommended for quantitative analysis of M-mode, B-mode, and Doppler ultrasound data. The system may be employed adjunctively in the performance of stress echocardiography in patients with suspected coronary artery disease either on-line by direct connection to the video signal output port of a suitable diagnostic ultrasound system or off-line by retrieving and processing previously stored data. The system permits the use of either standard or customized examination protocols, data analysis formulae, and report formats.

Device Description

The ECHO-COM device is a proprietary software program for cardiac data analysis designed for installation in an IBM-compatible personal computer (PC) and use with an MS-DOS Windows operating platform. Certain dedicated hardware items are provided with the software. The PC itself and the general-purpose peripheral hardware necessary to complete the system are supplied by or obtained from local vendors. The dedicated hardware supplied with the ECHO-COM system consists of a real-time frame grabber, ECG trigger kit, control panel, hardlock, and video cable. The digitizer card interface for the frame grabber has sufficient memory for the processing and storage of color images. This frame grabber captures all available information from the ultrasound system with which it is used during on-line operation including ECG trigger pulses and scale markers for distance measurements. The ECG trigger pulses permit time-gated cine loop recording, optimizing the system for the performance of stress-echo examinations. ECHO-COM software is designed to offer exceptional flexibility during either on-line or off-line operation. Images and cine loops may be archived in a variety of commonly used formats, including Macintosh, permitting integration into a wide range of networking systems such as InterNet and CompServe for convenient transfer of data to remote locations. A Review Module is provided that enables users to perform measurement, calculation, and documentation of stored images and loops at the workstation. An Examination Scheme Editor permits the user to supplement the pre-programmed protocols with customized examination approaches to conform with local requirements and preferences. Data from 2-D, M-mode, and Doppler examinations can be combined as desired. Levels and scanning positions for stress-echo examinations can be freely selected. The Report and Formula Editor enables the user to add custom-designed report formats and supplementary calculation formulae to the standard menu. A comprehensive range of cardiac ultrasound examination programs is provided including stress-echo test computations, semi-quantitative wall motion scoring, wall thickness evaluation, left ventricular volume studies, left ventricular function, color coding, M-mode functions, and Doppler functions. The disc summation method for quantitation of left ventricular volumes by two-dimensional echocardiography, as recommended by the American Society of Echocardiography, is employed. The tolerance levels utilized in the ECHO-COM program are based directly on the range of normal values adopted by the American Society of Echocardiography. All other equations and formulae included in the ECHO-COM program are based on accepted mathematical principles or derived from the published literature.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The provided document (K960665) is a 510(k) summary for a medical device submitted in 1996. The regulatory landscape and requirements for clinical studies, especially for AI/software as a medical device (SaMD), have evolved significantly since then. As a result, the "performance data" section in this summary is very brief and does not meet the standards or detail expected in modern submissions regarding acceptance criteria and studies.

Based on the information provided, the core "acceptance criteria" presented are related to the performance of the software's calculations compared to existing echocardiographic systems.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Numeric values calculated by ECHO-COM for MS-Windows program must align with corresponding values generated by the echocardiographic system itself.	"Software performance has been successfully validated through checks conducted in hospitals under typical clinical operating conditions in addition to internal testing throughout the software development cycle."
Adherence to quality standards for design, production, testing, and service procedures.	"All product design, production, testing, and service procedures are conducted in accordance with the following international quality standards: ISO 9001:1994 and ISO 9004-2:1991."

Study Details Based on Provided Text:

Given the 1996 context, the "study" described is a very high-level validation of calculated values, not a rigorous clinical trial as would be expected today.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "checks conducted in hospitals."
- Data Provenance: The "checks" were conducted "in hospitals under typical clinical operating conditions." This suggests prospective, real-world data collection during clinical use, but specific countries or retrospective/prospective details are not provided beyond this.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The ground truth for direct comparison appears to be the "corresponding values generated by the echocardiographic system itself." It is implicitly assumed that the operators/clinicians using the echocardiographic system are experts, but their number and specific qualifications are not detailed.
Adjudication method for the test set:
- Not applicable/Not specified. The validation method described is a direct comparison of numeric output from the ECHO-COM system to the source echocardiographic system. There is no mention of a human adjudication process to resolve discrepancies, though such a process might have implicitly occurred during "validation."
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:
- No. This type of MRMC comparative effectiveness study was not conducted or reported. The device is a "Cardiac Data Analysis Program" and is intended to calculate metrics based on ultrasound data, not to assist human readers in, for example, image interpretation in a diagnostic setting that would typically warrant an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The software's performance was evaluated by comparing its calculated numeric output directly against the numeric output of the echocardiographic system itself. This represents an algorithm-only performance evaluation in terms of its computational accuracy. Human interaction is involved in operating both systems, but the comparison is focused on the software's inherent ability to calculate correctly.
The type of ground truth used:
- Expert Consensus / Device Output: The ground truth for the software's calculations appears to be the "corresponding values generated by the echocardiographic system itself" (which itself provides quantitative measurements). The document also states that the device's "tolerance levels" and "equations and formulae" are "based directly on the range of normal values adopted by the American Society of Echocardiography" and "accepted mathematical principles or derived from the published literature." This suggests that the ground truth for the underlying methodology is established medical and scientific consensus, and the "validation" checks confirm the software accurately implements this consensus.
The sample size for the training set:
- Not specified. The document primarily discusses validation and compliance with established medical principles, not a machine learning training process with a specific training set size. This device pre-dates the widespread use of deep learning and large-scale training datasets for medical devices.
How the ground truth for the training set was established:
- Not applicable/Not specified in terms of a "training set" as understood in modern AI/ML development. The software's "knowledge" or "rules" are based on "accepted mathematical principles," "published literature," and "normal values adopted by the American Society of Echocardiography." These served as the foundation for the software's design and implementation, rather than a data-driven training process.

Summary

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K960665

510(k) SUMARY

MAY - 7 1996

COMPANY INFORMATION. 1.
Individual Software GmbH Name (Manufacturer) : Cone Instruments, Inc. Name (U.S. Agent) Address (Manufacturer) ・・ Petersberger Strasse 24-26 D-36037 Fulda, Germany Address (U.S. Agent) 5201 Naiman Parkway : Solon, Ohio 44139 Telephone (Manufacturer): 011-49-661-76031 (216) 246-1035 Telephone (U.S. Agent) . • Jay C. Cone, President Contact Person : Cone Instruments, Inc. 5201 Naiman Parkway Solon, Ohio 44139 (216) 248-1035 Date Prepared ・・ February 16, 1996
1. DEVICE NOMENCLATURE.

Trade Name	:	ECHO-COM for MS-Windows Version 2.0
Common Name	:	Cardiac Data Analysis Program
Classification Name	:	Computer Diagnostic, Programmable[74 DQK, 870.1425]

1. PREDICATE DEVICE.

Digisonics, Inc.	:	'Echo Reading Station' (Modification of
		'Echo-Comp' echocardiography analysis
		program
510(k) Number	:	K800766
SE Decision	:	April 24, 1980

DEVICE DESCRIPTION. 4.

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The dedicated hardware supplied with the ECHO-COM system consists of a real-time frame grabber, ECG trigger kit, control panel, hardlock, and video cable. The digitizer card interface for the frame grabber has sufficient memory for the processing and storage of color images. This frame grabber captures all available information from the ultrasound system with which it is used during on-line operation including ECG trigger pulses and scale markers for distance measurements. The ECG trigger pulses permit time-gated cine loop recording, optimizing the system for the performance of stress-echo examinations.

ECHO-COM software is designed to offer exceptional flexibility during either on-line or off-line operation. Images and cine loops may be archived in a variety of commonly used formats, including Macintosh, permitting integration into a wide range of networking systems such as InterNet and CompServe for convenient transfer of data to remote locations.

A Review Module is provided that enables users to perform measurement, calculation, and documentation of stored images and loops at the workstation. An Examination Scheme Editor permits the user to supplement the pre-programmed protocols with customized examination approaches to conform with local requirements and preferences. Data from 2-D, M-mode, and Doppler examinations can be combined as desired. Levels and scanning positions for stress-echo examinations can be freely selected. The Report and Formula Editor enables the user to add custom-designed report formats and supplementary calculation formulae to the standard menu.

A comprehensive range of cardiac ultrasound examination programs is provided including stress-echo test computations, semi-quantitative wall motion scoring, wall thickness evaluation, left ventricular volume studies, left ventricular function, color coding, M-mode functions, and Doppler functions.

The disc summation method for quantitation of left ventricular volumes by two-dimensional echocardiography, as recommended by the American Society of Echocardiography, is employed. The tolerance levels utilized in the ECHO-COM program are based directly on the range of normal values adopted by the American Society of Echocardiography. All other equations and formulae included in the ECHO-COM program are based on accepted mathematical principles or derived from the published literature.

5. INTENDED USES .

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6. COMPARISON WITH PREDICATE DEVICE.

The intended uses of the predicate device, the Digisonics cardiac analysis program, are very similar to those recommended for the subject device. Both are intended for use as work stations to organize findings generated during echocardiographic examina ions, and both facilitate calculations and quantitative analysis.

The subject device and the predicate device are also very similar in product concept. Both systems are software programs designed for use with an IBM-compatible PC using an MS-Windows operating platform. Both provide the clinician with computerized worksheets with graphics which are used to generate reports presenting the results of an echocardiographic examination.

Both systems may be employed on-line itilizing a data transfer linkage for interface to a suitable ultrasound instrument or off-line by either entering numeric values manually or calling up information from a database. Both programs incorporate formulae for quantitative data analysis based on the published work of recognized authorities in the field, and both allow the user to input additional formulae. Both program provide standard report formats and allow the user to customize formats when desired.

The principal differences between the ECHO-COM and the Digisonics system relate to on-line operation. The ECHO-COM is designed to accomplish ECG-gated cine loop recording which is valuable in the performance of stress-echo studies. Also, the ECHO-COM utilizes an advanced frame grabber which captures the distance measurement markers when transferring the ultrasound image, permitting operator verification of the accuracy of the dimensional information calculated by the ultrasound system in use.

The simularities and differences between the subject and predicate devices are presented in tabular form on the following page. It is concluded that the differences in technical characteristics between the two products are not significant in that there are no features of the subject device that raise new questions with respect to safety nor that could result in a decrease of effectiveness as compared to the predicate device.

7. PERFORMANCE DATA.

a. Hardware Performance. Hardware performance depends primarily on the PC and peripherals selected. Minimum and optimal specifications for use in the selection of hardware are given in the system operating manual to insure compatibility and proper performance. For the signal transfer functions performed by the dedicated hardware, an important consideration is the prevention of interference due to electrical potentials between interconnected units. This concern is addressed by the use of a UL listed high density mounting type photocoupler that provides an isolation voltage between input and output of 5,000V rms.

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COMPARISON OF TECHNICAL FEATURES: SUBJECT DEVICE VS. PREDICATE DEVICE

CHARACTERISTIC	SUBJECT DEVICECone InstrumentsECHO-COM for Windows	PREDICATE DEVICEDigisonicsEcho Reading Station
RequiredComputer	IBM-compatible PCMinimum RAM 8 MB	IBM-compatible PCRAM 8 MB
OperatingPlatform	MS-DOS 3.3 or higherMS-Windows 3.1 orhigher	MS-DOS 6.3MS-Windows 3.11
OperatingOptions	On-line (interfacedwith ultrasoundsystem) or off-line	On-line (interfacedwith ultrasoundsystem) or off-line
Video Capture	Frame grabber, ECG-gated cine looprecording	"Echo-Link" (fiberoptics)
DownloadingCapabilities	Black & white orcolor images,numeric data, ECGtrigger pulses,distance markers	Black & white orcolor images,numeric data
Ultrasound ModesAccepted	2-D, M-mode, Doppler	2-D, M-mode, Doppler
Database	Archiving of images,cine loops, and re-ports with graphics;convenient retrieval	Archiving of reportswith graphics; con-venient retrieval
Report Formats	Standard or custom-ized by user	Standard or custom-ized by user
CalculationFormulae	Standard (based onpublished authors)or user defined	Standard (based onpublished authors)or user defined
MeasurementData Verifi-cation	User can compareagainst valuesgenerated by basicultrasound system	User can compareagainst valuesgenerated by basicultrasound system
Data Transfer	Networking viaInterNet, Compi-Serve, etc.	Network compatible;fax capability

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b. Software Performance. Software performance can be evaluated by comparing the numeric values calculated by the ECHO-COM for MS-Windows program against corresponding values generated by the echocardiographic system itself. Software performance has been successfully validated through checks conducted in hospitals under typical clinical operating conditions in addition to internal testing throughout the software development cycle.

c. Quality Assurance. All product design, production, testing, and service procedures are conducted in accordance with the following international quality standards: ISO 9001":1994 and ISO 9004-2:1991.

8. CONCLUSION .

The ECHO-COM for MS-Windows Version 2.0 cardiac software program is closely similar in both intended use and technologic characteristics to the predicate device. The product raises no new questions regarding safety or effectiveness. All pertinent product data and all required certifications have been filed with the Food and Drug Administration. Cone Instruments, Inc. concludes that the subject device is substantially equivalent to devices of the same classification previously legally introduced into interstate commerce in the United States.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).