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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.

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.

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

• 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).

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