(58 days)
The ELI 150 is intended to be a high-performance, 12-lead, multifunctional electrocardiograph. As a resting electrocardiograph, ELI 150 simultaneously acquires data from 12 leads. Once the data is acquired, it can be reviewed and/or stored, and/or printed. It will be a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size.
Indications for Use:
- 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 150 is multi-channel, resting interpretation electrocardiographs. The ELI 150 simultaneously acquires data from up to 12 leads. Once the data is acquired, it can be reviewed, and/or printed.
The electrocardiogram (ECG) is a graphic description 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 150 is used by trained medical personnel to assist in the diagnosis of symptomatic patients with various rhythm patterns.
The ELI 150 is designed to be installed on a transport cart. The ELI 150 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 150 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 150 design and allows patient data entry as well as control of the functions and options available for the unit. The ELI 150 custom keyboard will include alphabetic, numeric, symbol and special function keys. The ELI 150 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 150 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, Modem, and / or GSM/GPRS module.
The sponsor, Mortara Instrument, Inc., did not provide specific quantitative acceptance criteria for the ELI 150 Electrocardiograph in this 510(k) summary. Instead, the submission focuses on demonstrating substantial equivalence to its predicate devices, the ELI 100 (K920627) and ELI 350 (K082946), by highlighting the addition of pediatric criteria to the existing VERITAS™ Interpretive Algorithm.
The study described is a performance evaluation of the VERITAS Pediatric ECG Interpretation algorithm.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Not explicitly stated as such, but inferred from the submission) | Reported Device Performance |
|---|---|
| Preamble: The device's primary goal is to be substantially equivalent to its predicate devices and function safely and effectively. The specific performance criteria for the VERITAS Pediatric ECG Interpretation algorithm are related to its diagnostic accuracy for pediatric ECGs. | "This data was utilized to calculate the Sensitivity, Specificity, Positive Accuracy and Negative Predictive Accuracy for the algorithm. This information is provided within the Physician's Guide to VERITAS with Adult and Pediatric Resting ECG Interpretation." (Specific numerical values for these metrics are not provided in this 510(k) summary). |
Note: The 510(k) summary does not explicitly state numerical acceptance criteria for sensitivity, specificity, or accuracy. It only states that these metrics were calculated and are available in a separate physician's guide.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document mentions "Clinical ECG's were randomly collected from various pediatric cardiology centers."
- Data Provenance:
- Country of Origin: Not explicitly stated, but "various pediatric cardiology centers" suggests multiple locations, likely within the US, given the FDA submission.
- Retrospective or Prospective: Not explicitly stated. The collection of "Clinical ECG's" and subsequent submission to a cardiologist suggests a retrospective collection of existing de-identified data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: "a cardiologist" (singular).
- Qualifications: "a cardiologist" (no further details on experience or sub-specialization are provided).
4. Adjudication Method for the Test Set:
- Method: Not explicitly described. The text states "These ECG's were then submitted to a cardiologist for reading without automatic interpretation (blind reading)." This implies a single expert's reading was used as the ground truth, rather than a consensus or adjudication process among multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done? No. The submission focuses on the algorithm's performance against a human reader's interpretation, not on how human readers improve with AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):
- Was it done? Yes. The study compared the algorithm's interpretations to the "blind reading" of a cardiologist. "The same ECGs were also interpreted by the VERITAS Pediatric ECG Interpretation algorithm."
7. Type of Ground Truth Used:
- Type: Expert consensus (from a single expert) / Expert interpretation. The ground truth was established by "a cardiologist for reading without automatic interpretation (blind reading)."
8. Sample Size for the Training Set:
- Not mentioned. The submission describes the evaluation of the VERITAS Pediatric ECG Interpretation algorithm, which would have been developed and trained prior to this evaluation. The training set details are not provided in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established:
- Not mentioned. The submission describes the evaluation of the algorithm and how its performance data was calculated, but not the specifics of its development or how the ground truth for its training was established.
§ 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).