(44 days)
The device is indicated for use to acquire, analyze, display and print 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, 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 250 is multi-channel, resting interpretation electrocardiographs. The ELI 250 simultaneously acquires data from up to 12 leads. Once the data is acquired, it can be reviewed, and/or stored, and/or printed.
The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. The cardiac data acquired and provided by the ELI 250 is used by trained medical personnel to assist in the diagnosis of symptomatic patients with various rhythm patterns.
The ELI 250 is designed to be installed on a transport cart. The ELI 250 is able to acquire, analyze, display and print electrocardiograms acquired through its internal Mortara front-end amplifier. The size of the screen will allow preview of the record for the technician to assess the quality of the acquired ECG.
The ELI 250 utilizes a monochrome (or optional color) LCD for display of ECG waveforms, menu options and status information. A custom keyboard is part of the ELI 250 design and allows patient data entry as well as control of the functions and options available for the unit. The ELI 250 custom keyboard will include alphabetic, numeric, symbol, cursor control and special function keys. The ELI 250 incorporates a thermal writer that allows printouts using several formats available to the user, from the standard to the Cabrera formats. The writer is also used by the unit for real time, continuous rhythm printout.
The ELI 250 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. RS 232, LAN, WLAN, and / or Modem.
The Mortara ELI 250 Electrocardiograph is intended to acquire, analyze, display, and print electrocardiograms, providing interpretation of data for physician consideration in a clinical setting for both adult and pediatric populations. It is not intended as a sole means of diagnosis or a vital signs monitor. Its primary upgrade from the predicate device (ELI 200) is the addition of pediatric criteria to the VERITAS Interpretive Algorithm.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical "acceptance criteria" for the VERITAS Interpretive Algorithm's performance concerning pediatric criteria. Instead, it states that the algorithm's performance was evaluated by calculating Sensitivity, Specificity, Positive Predictive Accuracy, and Negative Predictive Accuracy. These metrics are then included in the "Physician's Guide to VERITAS with Adult and Pediatric Resting ECG Interpretation."
Since specific numerical acceptance criteria and the exact reported performance values are not provided in this 510(k) summary, the table below reflects the general approach.
| Performance Metric | Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Not explicitly stated in the document) |
|---|---|---|
| Sensitivity | (Implied to be clinically acceptable) | Calculated and provided in the Physician's Guide |
| Specificity | (Implied to be clinically acceptable) | Calculated and provided in the Physician's Guide |
| Positive Predictive Accuracy | (Implied to be clinically acceptable) | Calculated and provided in the Physician's Guide |
| Negative Predictive Accuracy | (Implied to be clinically acceptable) | Calculated and provided in the Physician's Guide |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: "Clinical ECGs were randomly collected from various pediatric cardiology centers." The exact number of ECGs in the test set is not specified in the document.
- Data Provenance:
- Country of Origin: Not explicitly stated, but "various pediatric cardiology centers" suggests a clinical environment, likely within the United States given the FDA submission.
- Retrospective or Prospective: Not explicitly stated, but the description "clinical ECGs were randomly collected" suggests a retrospective collection of existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: "submitted to a cardiologist for reading" - This implies one expert was used.
- Qualifications of Experts: This expert was a "cardiologist." No further details on years of experience or sub-specialty (e.g., pediatric cardiologist) are provided.
4. Adjudication Method for the Test Set
- The document states that the ECGs were "submitted to a cardiologist for reading without automatic interpretation (blind reading)." This indicates a single-reader assessment.
- There's no mention of an adjudication method involving multiple experts (e.g., 2+1, 3+1).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was explicitly mentioned or described. The study focused on the algorithm's standalone performance against a cardiologist's blind reading.
- Therefore, there is no reported effect size of human readers improving with AI vs. without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
- Yes, a standalone performance evaluation was conducted. The study compared the "VERITAS Pediatric ECG Interpretation algorithm" directly against the "cardiologist for reading without automatic interpretation (blind reading)."
7. Type of Ground Truth Used
- The ground truth was established by expert opinion/reading. Specifically, it was the "reading without automatic interpretation (blind reading)" performed by a cardiologist.
8. Sample Size for the Training Set
- The document does not specify the sample size used for training the VERITAS Interpretive Algorithm for its pediatric criteria. It only mentions that the "ELI 250 utilizes the same VERITAS Interpretive Algorithm as the predicate device" and that the current submission is for the addition of "pediatric criteria."
9. How the Ground Truth for the Training Set Was Established
- The document does not describe how the ground truth for the training set was established. It only focuses on the evaluation (test set) of the added pediatric criteria. Given that the algorithm existed prior (in the predicate device), the training process for previous versions and for the pediatric criteria is not detailed here.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).