CARDIOSOFT/CARDIOSYS by MARQUETTE ELECTRONICS, INC.

CardioSoft / CardioSys are intended to be used in resting ECG, emergency- and stress-test departments to record, archive and disseminate ECG information.

They are intended to be used by trained operators under the direct supervision of a physician when ECG records are required in the judgement of a physician.

The arrhythmia detection portion of the CardioSoft / CardioSys stress test system is provided to the user for the convenience of automatic documentation. The CardioSoft / CardioSys offers no diagnostic opinion to the user. Instead, it provides a high fidelity instrument recording ECG waveforms during exercise, for the purpose of providing the operator with a tool to expedite the documentation of a test for which he/she renders his/her own medical opinion.
They are not designed for intracardial use.
They are not designed to provide alarms for arrhythmia and ST-segment measurement.
The devices are not intended for home use.
The intended use of CardioSoft / CardioSys does not differ from the intended use of the predicate device.

Device Description

CardioSoft / CardioSys is an ECG data acquisition and recording system designed and manufactured by HELLIGE GmbH.

CardioSoft / CardioSys allows to

record resting ECGs,
run stress test examinations,
measure and interprete the ECGs.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the HELLIGE CardioSoft / CardioSys device, based on the provided text:

Important Note: The provided document is a 510(k) Summary, which is a premarket submission to the FDA. It summarizes safety and effectiveness and often references testing to voluntary standards or comparisons to a predicate device, rather than providing detailed, full study protocols and results. Therefore, some specific details about the study (like exact sample sizes for all tests or detailed expert qualifications) might not be explicitly stated in this high-level summary.

1. Table of Acceptance Criteria and Reported Device Performance

Criteria (Standard Compliance)	Reported Device Performance
ANSI/AAMI EC11-1991 (ECG Devices - General)	CardioSoft / CardioSys comply with this standard.
ANSI/AAMI ECAR-1987 (Cardiac Arrhythmia Analyzers - Performance)	CardioSoft / CardioSys comply with this standard.
IEC 601-1 (Medical Electrical Equipment - General Requirements for Safety)	CardioSoft / CardioSys comply with this standard.
IEC 601-1-1 (Medical Electrical Equipment - General Requirements for Safety; Collateral Standard: Safety Requirements for Medical Electrical Systems)	CardioSoft / CardioSys comply with this standard.
IEC 601-1-2 (Medical Electrical Equipment - General Requirements for Safety; Collateral Standard: Electromagnetic Compatibility - Requirements and Tests)	CardioSoft / CardioSys comply with this standard.
IEC 601-2-25 (Medical Electrical Equipment - Particular Requirements for the Safety of Electrocardiographs)	CardioSoft / CardioSys comply with this standard.
EC Type-Examination for CE Mark	CardioSoft and CardioSys passed the EC type-examination and thus bear the CE mark.
Equivalence to Predicate Device (CARDIOGNOST EK 512)	"The results of these measures demonstrated that CardioSoft / CardioSys are as safe, as effective, and perform as well as the predicate device CARDIOGNOST EK 512." (This is the overarching acceptance criterion for 510(k) clearance, implying that performance is equivalent to the legally marketed predicate). This equivalence specifically mentions: - Technology: "basically employ the same technology" - Medical Functionality: "All parts of the software which determine the medical functionality of the device have been re-used from the predicate device."

Study that Proves Device Meets Acceptance Criteria:

The document states that the CardioSoft / CardioSys underwent a series of quality assurance measures and testing to demonstrate compliance and equivalence:

Requirements specification and design reviews
Code inspections
Software and hardware testing
Safety testing
Environmental testing
Final validation testing by an independent test group
Field tests

These activities collectively demonstrated that the device complies with the listed voluntary standards (ANSI/AAMI, IEC) and performs as safely and effectively as the predicate device, CARDIOGNOST EK 512.

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

Sample Size for Test Set: Not explicitly stated in terms of number of patients or ECGs. The document mentions "final validation testing by an independent test group" and "field tests," but does not provide specific numbers for these test sets.
Data Provenance: Not explicitly stated. Given that HELLIGE GmbH is located in Freiburg, Germany, the testing was likely conducted in Germany or within Europe. The status as a 510(k) submission means the device aimed for clearance in the US, but the origin of the test data isn't detailed.

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

Not explicitly stated. The document mentions that the arrhythmia detection portion provides "automatic documentation" and "offers no diagnostic opinion to the user." Instead, it's a "tool to expedite the documentation of a test for which he/she renders his/her own medical opinion." This suggests that human expert interpretation remains paramount. For the validation testing, experts would have been involved, but their number and specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed.

4. Adjudication Method for the Test Set

Not explicitly stated. Given the context of compliance with AAMI standards and comparison to a predicate, it's highly probable that a rigorous comparison of measurements and interpretations (likely human expert interpretation vs. device output) was performed. However, the specific adjudication method (e.g., 2+1, 3+1 consensus) is not described in this summary.

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

Not explicitly stated/performed in this summary. The document focuses on the device's compliance with standards and equivalence to a predicate device in a standalone capacity. It does not describe a study comparing human reader performance with and without AI assistance. The device is described as a "high fidelity instrument recording ECG waveforms" and a "tool to expedite documentation," rather than an AI that provides diagnostic opinions.

6. Standalone Performance Study (Algorithm Only)

Yes, implied. The document extensively discusses the device's compliance with voluntary standards (ANSI/AAMI EC11-1991, ANSI/AAMI ECAR-1987, IEC standards) and its performance as a standalone system. The stated "quality assurance measures" including "software and hardware testing" and "final validation testing" would have assessed the device's performance independently against these standards and the predicate device. The device's function is to record, measure, and interpret ECGs, and its effectiveness in doing so would have been evaluated as a standalone algorithm/system.

7. Type of Ground Truth Used

Physiological measurements and implicitly expert consensus. For ECG devices, ground truth for measurements (e.g., intervals, amplitudes) is typically established through precisely calibrated signals and often validated against expert manual measurements or other highly accurate reference systems. For arrhythmia detection, the ground truth would involve expert cardiologists' interpretations of the ECG waveforms. The statement "The CardioSoft / CardioSys offers no diagnostic opinion to the user. Instead, it provides a high fidelity instrument recording ECG waveforms during exercise, for the purpose of providing the operator with a tool to expedite the documentation of a test for which he/she renders his/her own medical opinion" suggests that human medical opinion forms the ultimate ground truth for clinical diagnosis. However, for validating the instrument's performance in recording and measuring, standardized signals and possibly expert adjudicated interpretations would be used.

8. Sample Size for the Training Set

Not applicable/Not stated. This document describes a device from 1995. While modern AI/ML devices rely heavily on "training sets," the CardioSoft / CardioSys's "medical functionality" largely re-used from the predicate device and compliance with standards suggests a rule-based or algorithmic approach rather than a machine learning model that requires a distinct "training set" in the contemporary sense. The "training" in this context would likely refer to the development and refinement of algorithms based on established physiological rules and a dataset of ECGs used for initial development and testing, rather than a separate, formally delineated "training set" for an AI model. Therefore, a specific sample size for a "training set" is not provided.

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

Not applicable/Not stated. As per the point above, the concept of a "training set" for a machine learning model is not explicitly relevant to this 1995 device summary. The ground truth for the underlying algorithms would have been established through a combination of:
- Physiological principles: ECG waveform characteristics, intervals, amplitudes associated with normal and abnormal rhythms.
- Clinical expertise: Consensus of cardiologists or ECG experts on the classification of rhythms and abnormalities.
- Reference databases: Potentially, established databases of annotated ECGs (though the specifics are not mentioned).
- Benchmarking against the predicate device: The fact that the software's "medical functionality" was re-used from the predicate device implies that the ground truth for those algorithms would have been established during the development and validation of the predicate (CARDIOGNOST EK 512).

Summary

{0}------------------------------------------------

K951130

HELLIGE

K951130 APR - 4 1996

HELLIGE GMBH · Postfach 728 · D-79007 Freiburg i. Br.

HELLIGE GMBH Munzinger Str. 3 D-79111 Freiburg im Breisgau Germany Phone (0761) 4543-0 Telex 7 72 705

Section 2 - Summary & Certification

Date 03-09-1995

510(k) Summary of Safety and Effectiveness 2.1

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter	HELLIGE GmbHMunzinger Str. 379111 Freiburg, GermanyTelephoneFaxContact person:	+49-761-4543-0+49-761-4543-223Mr. Klaus Rudolf
Device	Trade name:Classification name:	CardioSoft / CardioSysElectrocardiograph;Detector and Alarm, Arrhythmia
Predicate Device	HELLIGE CARDIOGNOST EK 512
Device Description	CardioSoft / CardioSys is an ECG data acquisition and recording systemdesigned and manufactured by HELLIGE GmbH.CardioSoft / CardioSys allows to- record resting ECGs,- run stress test examinations,- measure and interprete the ECGs.
Intended Use	CardioSoft / CardioSys are intended to be used in resting ECG,emergency- and stress-test departments to record, archive anddisseminate ECG information.They are intended to be used by trained operators under the directsupervision of a physician when ECG records are required in thejudgement of a physician.

Commerzbank AG Freiburg	BLZ 680 400 07	Kto.-Nr. 1400050/00
Dresdner Bank AG Freiburg	BLZ 680 800 30	Kto.-Nr. 4012483/00
Sparkasse Freiburg	BLZ 680 501 01	Kto.-Nr. 2006796
Volksbank Freiburg	BLZ 680 900 00	Kto.-Nr. 12191200
Postbank Karlsruhe	BLZ 660 100 75	Kto.-Nr. 52061-754
Landeszentralbank Freiburg	BLZ 680 000 00	Kto.-Nr. 60007254

{1}------------------------------------------------

HELLIGE

	- The arrhythmia detection portion of the CardioSoft / CardioSys stresstest system is provided to the user for the convenience of automaticdocumentation. The CardioSoft / CardioSys offers no diagnosticopinion to the user. Instead, it provides a high fidelity instrumentrecording ECG waveforms during exercise, for the purpose ofproviding the operator with a tool to expedite the documentation of atest for which he/she renders his/her own medical opinion.
	- They are not designed for intracardial use.
	- They are not designed to provide alarms for arrhythmia and ST-segment measurement.
	- The devices are not intended for home use.
	The intended use of CardioSoft / CardioSys does not differ from theintended use of the predicate device.
Technology	CardioSoft / CardioSys basically employ the same technology as thepredicate device.All parts of the software which determine the medical functionality of thedevice have been re-used from the predicate device.The main difference between CardioSoft / CardioSys and the predicatedevice is that commercially available hardware and system software areused instead of proprietary hardware and software.
Performance	CardioSoft / CardioSys comply with the voluntary standardANSI/AAMI EC11-1991, ANSI/AAMI ECAR-1987, IEC 601-1,IEC 601-1-1, IEC 601-1-2 and IEC 601-2-25.CardioSoft and CardioSys passed the EC type-examination and thus bearthe CE mark.
	The following quality assurance measures were applied to the developmentof CardioSoft / CardioSys:
	Requirements spefication and design reviews, code inspections, softwareand hardware testing, safety testing, environmental testing, final validationtesting by an independent test group, field tests.
	The results of these measures demonstrated that CardioSoft / CardioSys areas safe, as effective, and perform as well as the predicate deviceCARDIOGNOST EK 512

Signature:

Maro Prdory

Date: March 9, 1935

Name:

Klaus Rudolf, Manager Regulatory Affairs

510(k) Notification 'CardioSoft / CardioSys'' - March 09 1995

Regulation Number and Section

N/A