The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients. The information consists of measurements, text, and digitized waveforms. The MUSE Cardiology Information System provides the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison. The MUSE Cardiology Information System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or facility providing patient care. The MUSE Cardiology Information System is not intended for primary monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison.

Device Description

The MUSE Cardiology Information System comprises a client workstation/server configuration whose purpose is to manage diagnostic cardiology data. The MUSE Cardiology Information System is a network PCbased system that provides centralized storage and ready access to a wide range of data/reports (e.g. Resting ECG, Stress, Holter, HiRes) from GE and non-GE diagnostic and monitoring equipment.

AI/ML Overview

The provided 510(k) summary for the "MUSE Cardiology Information System" does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance, nor does it describe a specific study proving the device meets acceptance criteria in the manner requested.

The document is a general 510(k) submission summary, primarily focused on establishing substantial equivalence to a predicate device (K992637) and outlining the general development and testing processes. It lacks specific quantitative performance metrics, detailed study designs, or ground truth establishment methods for a clinical evaluation.

Here's a breakdown of what is and isn't present in relation to your request:

Information NOT Found in the Document:

A table of acceptance criteria and the reported device performance: The document states that "The results of these measurements demonstrated that the MUSE Cardiology Information System is as safe, as effective, and performs as well as the predicate device," but it does not provide specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or quantitative performance data to back this claim.
Sample sizes used for the test set and the data provenance: No information on the number of cases or the nature of the data (country, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and their qualifications: No details about experts for ground truth.
Adjudication method: No information provided.
Multi-reader multi-case (MRMC) comparative effectiveness study: No mention of such a study or an effect size. The focus is on a system for managing data, not an AI for interpretation.
Standalone (algorithm-only) performance: As this is an information system for managing and reviewing ECG data, rather than an automated diagnostic algorithm, the concept of "standalone performance" in the AI sense isn't directly applicable for an interpretation algorithm. The system itself is "standalone" in its function of data management.
Type of ground truth used: No specific mention of ground truth types (e.g., expert consensus, pathology, outcome data) that would typically be associated with an AI diagnostic device.
Sample size for the training set: Not applicable as this is not an AI/ML diagnostic algorithm.
How the ground truth for the training set was established: Not applicable.

What the Document Does Mention Regarding "Testing":

The document lists "Test Summary" items, which are related to software development and validation best practices, rather than a clinical performance study evaluating diagnostic accuracy. These include:

Risk Analysis
Requirements Reviews
Design Reviews
Testing on unit level (Module verification)
Integration Testing (System verification)
Final acceptance testing (Validation)
Performance testing
Safety testing
Environmental Testing
Conclusion: "The results of these measurements demonstrated that the MUSE Cardiology Information System is as safe, as effective, and performs as well as the predicate device."

Summary of Device and its Purpose:

The MUSE Cardiology Information System is described as a "network PC-based system that provides centralized storage and ready access to a wide range of data/reports (e.g. Resting ECG, Stress, Holter, HiRes) from GE and non-GE diagnostic and monitoring equipment." Its primary function is to "store, access and manage cardiovascular information" and "provide the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison."

It clearly states: "The MUSE Cardiology Information System is not intended for primary monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison."

Conclusion Based on the Provided Information:

Based solely on the provided 510(k) summary, it's not possible to provide the requested detailed information regarding acceptance criteria and a specific study proving the device meets them in the context of diagnostic accuracy or AI performance. The document focuses on the system's ability to manage, store, and display cardiology data comparably to a predicate device, and its safety and effectiveness are confirmed through general software validation and testing rather than a clinical performance study with defined ground truth and statistical endpoints for diagnostic performance.

This device predates the widespread regulatory focus on AI/ML-driven diagnostics, and its 510(k) summary reflects regulatory requirements for a data management system rather than an automated diagnostic tool.

Summary

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K050614

R/1

Section 2 Summary

APR - 5 2005

510(k) Summary of Safety and Effectiveness

March 7, 2005 Date:

GE Medical Systems Information Technologies Submitter: 8200 West Tower Avenue Milwaukee, WI 53223 USA
Lisa M. Baumhardt Contact Person: Regulatory Affairs Specialist GE Medical Systems Information Technologies Phone: (262) 293-1699 Fax: (262) 293-1460

Device:	Trade Name:	MUSE Cardiology Information System
	Common/Usual Name:	ECG Analysis Computer
	Classification Names:	21 CFR 870.1425 Computer, Diagnostic, Programmable
	Predicate Device:	MUSE Cardiovascular Information System (K992637)

The MUSE Cardiology Information System comprises a client Device Description: workstation/server configuration whose purpose is to manage diagnostic cardiology data. The MUSE Cardiology Information System is a network PCbased system that provides centralized storage and ready access to a wide range of data/reports (e.g. Resting ECG, Stress, Holter, HiRes) from GE and non-GE diagnostic and monitoring equipment.

The MUSE Cardiology Information System is intended to store, access and Intended Use: manage cardiovascular information on adult and pediatric patients. The information consists of measurements, text, and digitized waveforms. The MUSE Cardiology Information System provides the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison. The MUSE Cardiology Information System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or facility providing patient care. The MUSE Cardiclogy Information System is not intended for primary monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison.
The proposed MUSE Cardiology Information System employs the same Technology: functional scientific technology as the predicate device MUSE Cardiovascular Information System (K992637).

The MUSE Cardiology Information System complies with the voluntary Test Summary: standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the device:

Risk Analysis ●
Requirements Reviews .
Design Reviews .
Testing on unit level (Module verification) .
Integration Testing (System verification) �
Final acceptance testing (Validation) .
Performance testing .
Safety testing .
Environmental Testing .
The results of these measurements demonstrated that the MUSE Cardiology Conclusion: Information System is as safe, as effective, and performs as well as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/11 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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines resembling an abstract human figure or a bird in flight.

Public Health Service

APR - 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

General Electric Medical Systems Information Technologies c/o Ms. Lisa Baumhardt Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223

Re: K050614

Trade Name: MUSE Cardiology Information System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: March 22, 2005 Received: March 23, 2005

Dear Ms. Baumhardt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regars and ment date of the Medical Device Amendments, or to commerce prof to hay 28, 1976, the encomes with the provisions of the Federal Food. Drug. devices mat have been rechasined in accee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, mercere, market the Act include requirements for annual registration, listing of getteral controls provisions of the 110 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 If your device is classified (500 a00 ro) ins existing major regulations affecting your device can may be subject to suell additional ocultions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oods neements concerning your device in the Federal Register.

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Page 2 - Ms. Lisa Baumhardt

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri- 3 issumter of a beadswice complies with other requirements of the Act that I DA has made a decommancir that your rederal agencies. You must or ally recetal statutes and regulations and limited to: registration and listing (21 comply with an the Act 31equirements, 01); good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro nevice (seting your device as described in your Section 510(k) This letter witi anow you to begin maxioning your as a review of your device to a legally premarket notheation: "The PDF miding of castion 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 If you desire specific acrite for your acceller. Also, please note the regulation entitled, Coliable of Computers of Compullion in (21CFR Part 807.97). You may obtain Misolanding by reference to premanteentibilities under the Act from the Division of Small other general information on your respective Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

Sincerely yours,

Bhimmar 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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KO50614

510(k) Number (if known):

Device Name:

MUSE Cardiology Information System

Indications For Use:

The MUSE Cardiology Information System is intended to store, access and manage cardiovascular I he MOSE Catulology information Oystems. The information consists of measurements, text, and motimation on adult and pockate partials gy Information System provides the ability to review and digitized wavelorms. The MODE Catalotogy attrough the use of reviewing, measuring, and editing edit electrocandiographic procedures on serees, the onganisation System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital used ulticity providing patient of a nooned Cardiology Information System is not intended for of facility providing patient care. The MOSE of and intended for pediatic serial comparison.

Prescription Use__X__ (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Per 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)

Bhummer

ivision Sian-Off Division of Cardlovascular Devices 510(k) Numbe

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).