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The Kenz Cardico 1211 is indicated for routine ECG acquisition and ECG signal analysis. It is equipped with an auto-analysis function and is not intended to replace the physician's reading of ECGs. Instead, it is intended to assist physicians and supplement their readings by: providing preliminary interpretations of ECG records which need to be confirmed or edited by the physician, who integrates ECG findings with other relevant clinical data; providing auto-analysed measurements of many ECG parameters, which need to be confirmed by the physician. The device is applicable only to adults (age > 19 years).

Applications: Cardico 1211 is intended to be used as part of health examination of general population, and as part of laboratory tests and clinical examination to diagnose various cardiac abnormalities including myocardial ischemia/infarction, ventricular hypertrophy, cardiac arrhythmias, and atrioventricular (AV) block.
Locations: Hospitals.

Caution: US Federal law restricts this device to sale by or on the order of a physician.

Kenz Cardico 1211 is an electrocardiograph with the following functions and capabilities.

· Simultaneous acquisition of the 12-Lead electrocardiogram (ECG).

· The sampling frequency of P-QRS-T deflections is 1 kHz.

• · The sampling frequency of the pacemaker pulse detection is 10 kHz.
• · 5.7 inch LCD display providing the following information.
  • a) ECG waveform
  • b) Patient's demographic data
  • c) ECG diagnostic interpretation
  • d) Summary of Internal Memory data
• · Thermal printer that will print ECG waveforms and analysis reports.
• · Digital filters to minimize AC interference, baseline drift and electromyogram interference.
• · Built-in memory and external memory (Compact Flash card) for 1,000 12-Lead ECG data.
• · As a measure against cybersecurity, in order to secure the integrity of the data in the external memory, only the CF card specially formatted by Suzuken Co., Ltd. can be used with Kenz Cardico 1211.
• · Built-in power supply unit (AC 110-240 V).
• · Built-in battery, after charged for 8 hours, supports one hour operation during emergency.
• · ECG interpretation software providing the following information.
  • a) Summary of measured values of ECG waveform in each Lead
  • b) Rhythm analysis statements
  • c) Morphology analysis statements
  • d) Pacemaker pulse detection and Pacemaker rhythm diagnosis
  • e) Provide multiple diagnostic outputs for a single ECG, if it contains multiple diagnostic findings
• · Patient cable with D-sub 15 pin connector and 4.0 mm plugs is used for recording 12-Lead resting ECG with the device.
• · ECG electrodes are not provided with the device (Kenz Cardico 1211). Disposable chest/limb electrodes connected to the ECG Adaptor Clips of the plug size 4.0 mm are compatible with the Kenz Cardico 1211.

Here's a breakdown of the acceptance criteria and study details for the Kenz Cardico 1211, based on the provided document:

Acceptance Criteria and Device Performance

The core acceptance criterion is to demonstrate that the diagnostic performance of the Kenz Cardico 1211 (including its updated ECG interpretation software) is non-inferior to its predicate device, the Kenz Cardico 1201.

Table of Acceptance Criteria and Reported Device Performance

Study Details

2. Sample Sizes and Data Provenance

• Test Set Sample Size: A total of 2,451 ECGs from 2,451 subjects were used for diagnostic performance testing.
• Data Provenance: The data came from two sources:
  • CSE Database (Common Standards for Electrocardiography): Used for Type A statements and contributing to Type B and C statements. The country of origin for the CSE database is not explicitly stated in this document but is generally a well-known international standard database.
  • Suzuken Databases (Suzuken Database-1, Suzuken Database-2, Suzuken Database-3 (Pacemaker rhythm), Acute MI database): Used to supplement the CSE database for various statement types. This implies the data likely originated from Japan, given Suzuken Co., Ltd. is based there.
• Retrospective/Prospective: The document does not explicitly state whether the data was retrospective or prospective, but the use of established databases (CSE and Suzuken's own) suggests a retrospective approach.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Number of Experts: The document refers to "Cardiologist Consensus" as the reference of truth, but it does not specify the number of cardiologists involved in establishing this consensus.
• Qualifications of Experts: The experts are described as "Cardiologist(s)". No further details about their years of experience or specific sub-specialties are provided in this document.

4. Adjudication Method (Test Set)

The adjudication method is described as "Cardiologist Consensus" for all Type B and Type C statements, and for Type A statements when "Cardiologist Consensus" was available (otherwise "Clinical Truth" was used for Type A). The document states that the "Creation of Cardiologist Consensus is described in detail in Att. 18-1," suggesting a formal process, but the details of that process (e.g., how disagreements were resolved, majority vote, etc.) are not included in these provided pages.

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

• A comparative effectiveness study was done by comparing the Kenz Cardico 1211's performance directly against the predicate device, Kenz Cardico 1201. However, this was a device-to-device comparison for standalone performance, not a human reader improvement study.
• Effect Size of Human Readers Improvement with/without AI: This study did not involve human readers in a comparative effectiveness study with and without AI assistance. It focused on the algorithm's performance compared to another algorithm. The device's function is to assist physicians, but this study did not quantify that assistance.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was done. The entire "Diagnostic performance testing" section (Section 10-2) describes the comparison of the Kenz Cardico 1211's auto-analysis function against established ground truth, and against the auto-analysis function of the Kenz Cardico 1201. This is a direct assessment of the algorithm's performance without human intervention in the evaluation process.

7. Type of Ground Truth Used

• Expert Consensus: The primary ground truth for Type A, B, and C statements was "Cardiologist Consensus."
• Clinical Truth: For some Type A statements, "Clinical Truth" was also used (specifically mentioned for the "Acute MI" database). This would typically refer to definitive clinical diagnoses based on a broader range of patient data (e.g., lab results, imaging, follow-up, pathology, not just the ECG).

8. Sample Size for the Training Set

The document does not explicitly state the sample size for the training set used to develop the ECG interpretation software of the Kenz Cardico 1211. It mentions that the software "reflects the results of many ECG clinical studies published after the development of the ECG interpretation software of Kenz Cardico 1201," implying a significant body of data, but not a specific training set size.

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

The document does not explicitly describe how the ground truth for the training set was established. It only refers to the software "reflecting the results of many ECG clinical studies published." This suggests that the algorithm was likely developed and refined using a large corpus of previously interpreted ECG data from these clinical studies, where the diagnoses would have been established by medical experts (likely cardiologists) in those respective studies.

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