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The device is indicated for use to acquire, analyze, display, transmit, print, record and store electrocardiograms.
The device is indicated for use to provide interpretation of the data for consideration by a physician.
The device is indicated for use in a clinical setting, or mobile environment (including prehospital, emergency services, ambulance and patient transport), by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
The device is indicated for use on adult and pediatric populations.
The device is not intended to be used as a vital signs physiological monitor.

The ELI 10 is a multi-channel, portable electrocardiograph. The ELI 10 simultaneously acquires data from up to 12 leads. Once the data is acquired, it can be reviewed, stored, transmitted and/or printed (using an external, optional printer). The ELI 10 is designed to be installed on a transport cart. The ELI 10 is able to acquire, analyze, display, transmit, print, record and store electrocardiograms acquired through its internal Mortara front-end amplifier. The size of the screen will allow preview of the technician to assess the quality of the acquired ECG. The ELI 10 utilizes a monochrome LCD for display of ECG waveforms, menu options and status information. A custom keyboard is part of the ELI 10 design and allows patient data entry as well as control of the functions and options available for the unit. The ELI 10 custom keyboard includes alphabetic, numeric, symbol, cursor control and special function keys. When an ECG is acquired, a preview will be displayed in this window. The ECG format used to display the waveforms will the configured printing format. Gain, speed and filter are applied to both screen and printout at the same time (Printing function available only through an external optional printer). The ELI 10 will offer storage capability in order to retrieve or transmit stored records. Transmission can be achieved using one of the optional communication media designed in the unit: Modem, LAN, VolvaN, GSM/GPRS, and/or USB port.

Here's a breakdown of the acceptance criteria and the study details for the Mortara ELI 10 Electrocardiograph's Pediatric Criteria for the VERITAS™ Interpretive Algorithm, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative table format for the interpretive algorithm. Instead, it describes a "clinically acceptable" performance. The primary criterion implicitly is that the performance of the algorithm should be similar to or considered acceptable by a cardiologist.

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

• Sample Size for Test Set: Approximately 1300 15-lead ECGs (standard 12 leads plus V3R, V4R, and V7).
• Data Provenance:
  • Country of Origin: Not specified, but collected from "various pediatric cardiology centers."
  • Retrospective or Prospective: Retrospectively collected ("randomly collected").

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

• Number of Experts: Singular expert ("a cardiologist").
• Qualifications of Experts: "a cardiologist" (no further specific experience or specialization, beyond being a cardiologist).

4. Adjudication Method for the Test Set

The adjudication method appears to be a single blind reading by "a cardiologist" of raw ECGs without the automatic interpretation.

• Method: A single cardiologist performed a "blind reading" of the ECGs without the algorithm's interpretation.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted to assess the effect size of human readers improving with AI vs. without AI assistance. The study described compares the algorithm's interpretation to a single cardiologist's interpretation.

6. Standalone (Algorithm Only) Performance

Yes, a standalone (algorithm only) performance assessment was done. The study specifically states: "The same ECGs were interpreted by the VERITAS Pediatic ECG Interpretation algorithm. The performance obtained by the algorithm is considered clinically acceptable." This indicates the algorithm's performance was evaluated independently against the ground truth established by the cardiologist.

7. Type of Ground Truth Used

The ground truth used was expert consensus / expert reading. Specifically, it was the "blind reading" performed by a cardiologist.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It mentions that the VERITAS Interpretive Algorithm was "included within the cleared 510(k) Premarket Notification (K082946)" and that "ELI 10 utilizes the same VERITAS Interpretive Algorithm as the ELI 350 (K082946)". This suggests the pediatric criteria were an addition to an existing, previously validated algorithm, but the training data for the base algorithm or this specific pediatric update is not detailed here.

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

The document does not provide details on how the ground truth for the training set was established. It only describes the process for the validation/test set.

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