(35 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 380 is a multichannel, high-performance resting interpretive electrocardiograph utilizing a large high resolution color LCD for display of ECG waveforms, menu options and status information. The LCD provides a preview of the ECG for the clinician to assess its quality. The overall design of the ELI 380 is a "clamshell" style where the LCD screen can be closed over the printer when the unit is shipped or not in use. The ELI 380 operates from an internal battery or AC power. A full size keyboard is part of the ELI 380 design and allows patient data entry as well as control of the functions and options available for the unit. The keyboard includes alphabetic, numeric, symbol, cursor control, special function keys and integrated pointing device. The ELI 380 keyboard is constructed of a continuous surface of chemically strengthened glass permitting ease of cleaning and disinfection. The ELI 380 is designed to be installed on an optional transport cart. The ELI 380 is able to acquire data via direct or wireless patient connection. Once the data is acquired it can be analyzed, reviewed, stored, printed or transmitted. The ELI 380 is able to retrieve and transmit stored records. Transmission can be achieved using one of the optional communication media designed in the unit: LAN, WLAN, and/or USB port. The ELI 380 incorporates a full size thermal writer that allows printouts using several formats. The writer is also used for real time, continuous rhythm printouts at various speeds. The ELI 380 offers, adult and pediatic interpretation capability to assist the physician over-read of the electrocardiogram. The ELI 380 maintains a running buffer and a condensed display allowing the user to identify a preferred 10 second sample to acquire. The ELI 380 can also suggest the "Best 10" second segment from the buffer based on the quality of the ECG.
This document (K142105) for the Mortara ELI 380 Electrocardiograph is a "Special 510(k) Notification." This type of submission is typically used for modifications to a manufacturer's own legally marketed device, where the modifications do not affect the intended use or fundamental scientific technology. Therefore, the focus of the provided document is on demonstrating that the ELI 380 is substantially equivalent to its predicate device (Mortara ELI 350 Electrocardiograph, K082946) through engineering and software verification and validation, rather than extensive clinical performance studies to establish new acceptance criteria.
As a result, detailed acceptance criteria for a specific medical condition, a study proving device performance against those criteria, or information on ground truth establishment and expert adjudication typical of AI/CADe submissions are not present in this document. The document emphasizes that clinical performance testing was "not performed and is not necessary to demonstrate safety and effectiveness" because the device is an update to an existing product and leverages similar technology.
However, I can extract information related to the general performance testing conducted to ensure substantial equivalence:
1. A table of acceptance criteria and the reported device performance
Since specific clinical acceptance criteria (e.g., sensitivity, specificity for a particular ECG anomaly) for a new clinical claim are not established in this Special 510(k), the "acceptance criteria" here refer to meeting engineering and software specifications for the updated device to be considered substantially equivalent to its predicate.
| Acceptance Criteria Category | Reported Device Performance (Summary from Document) |
|---|---|
| Software Functionality | Complies with its predetermined specification; vigorously verified and validated. (Implies all functions, including acquisition, analysis, display, printing, interpretation, storage, transmission, patient data entry, and "Best 10" segment selection, perform as designed). |
| Electrical Safety | Evaluated in accordance with applicable Standards; complies with predetermined specifications. |
| Electromagnetic Compatibility (EMC) | Tested in accordance with applicable Standards; complies with predetermined specifications. |
| Bench Performance/Functional | Tested in accordance with internal requirements and procedures; complies with predetermined requirements (e.g., accurate ECG waveform acquisition, processing, display, and interpretation functionality as per device specifications). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify a sample size for a "test set" in the context of clinical performance evaluation (e.g., patient ECGs used to evaluate diagnostic accuracy).
- The performance testing described (software, electrical, EMC, bench) would typically involve internal engineering test cases and simulations, not patient data in the sense of clinical trials.
- Data provenance: Not applicable in the context of the reported engineering and software performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The document focuses on engineering and software validation, not clinical diagnostic accuracy. The device provides "interpretation of the data for consideration by a physician" and explicitly states that "interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read." This indicates the device is an assistive tool, and the "ground truth" for clinical interpretation ultimately rests with the physician.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no clinical test set requiring expert adjudication for diagnostic accuracy.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC study was not performed. The document explicitly states: "Performance Testing - Clinical - Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara ELI 380 Electrocardiograph." The device includes interpretation capability as an assistive tool, not a standalone diagnostic.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. While the device has "interpretation capability," the "Indications for Use" clearly state: "The device is not intended as a sole means of diagnosis" and "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." This clarifies that it is not intended for standalone diagnostic performance without human oversight.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for clinical diagnostic performance. The "ground truth" for the engineering and software validation would be the predefined functional and technical specifications of the device.
8. The sample size for the training set
- The document describes a submission for a modification to an existing device (Special 510(k)). It does not mention a "training set" in the context of machine learning or AI model development. The ECG interpretation capability is referred to as "interpretation capability," implying it's based on established algorithms rather than a newly trained AI model requiring a distinct training set in the modern sense.
9. How the ground truth for the training set was established
- Not applicable. As no "training set" for an AI model is described, there's no information on how its ground truth would have been established. The interpretative algorithms likely leverage established physiological principles and prior knowledge within electrocardiography.
§ 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).