(77 days)
ELAN® is a digital 12 channel electrocardiograph designed for acquisition and digitization of conventional diagnostic 12-lead simultaneous ECG waveforms and ECG data and real-time visualization of 1 to 6 leads on its built-in LCD monitor. ELAN® can also record and store in its internal memory up to 100 ECG tests. Each ECG test can be analyzed, printed on the internal thermal printer and/or sent to a PC via serial cable, LAN or modem. ELAN® can perform automatic measurements of ECG waveform and preliminary interpretation of ECG test; measurements and diagnostic statements are offered to the physician on an advisory basis only; the physician is asked to review and validate or change the ECG interpretation.
ELAN® is a digital 12 channel electrocardiograph for the simultaneous acquisition of the 12 ECG leads, featuring 6-lead LCD screen, alphanumeric keyboard and high resolution thermal printer on 210 mm paper. ELAN ® can record and store in its internal memory up to 100 ECG tests. Each ECG test can include patient data, ECG measurements, automatic interpretation, physician report. Stored ECG tests can be reviewed, printed on the internal thermal printer and/or sent to a local or remote PC via serial cable, LAN network or external standard modem.
The provided text describes a 510(k) submission for the ELAN® Digital 12 Channel Electrocardiograph, aiming to establish substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, typically without requiring extensive new clinical studies. Therefore, the information provided focuses on technical specifications and functional comparisons rather than detailed performance studies with acceptance criteria in the same way one might find for a novel AI/ML device.
However, based on the document's content, we can infer acceptance criteria for "substantial equivalence" and report the device's characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are implied to be that the new device's specifications and performance are comparable to the predicate device. The following table directly compares the ELAN® device to its predicate, the M1770A Pagewriter 200i, for various technical specifications. The acceptance criterion for each specification is, therefore, that the ELAN® device's value is either the same as, or functionally equivalent or superior to, the predicate device.
| Specification | Predicate Device (PAGEWRITER 200i, K954980) - Acceptance Criteria | ELAN® Digital 12 Channel Electrocardiograph - Reported Device Performance |
|---|---|---|
| CONFIGURATION | Tabletop / cart mount (optional) | Tabletop |
| LEADS | ||
| Lead switching | Automatic / manual | Automatic / manual |
| Sensitivity, mm/mV | 5, 10, 20 | 5, 10, 20 |
| Calibration signal | Manual | Manual |
| Frequency range, Hz Diagnostic | 0.05 - 150 | 0.05 - 150 |
| Filtered | Notch, EMG, baseline wander | Notch, EMG, baseline wander |
| Input impedance, Mohms | 100 | 160 Mohms at 10 Hz |
| CMRR @ 60 Hz, dB | 110 | > 100 |
| Leads-off indicator | Yes | Yes |
| RECORDER | ||
| Recording method | Digital thermal array | Digital thermal array |
| Paper size | A4 | 210 mm z-fold |
| Lead marker | Automatic | Automatic |
| Timing marker | No | No |
| Event marker | No | No |
| Chart speed, mm/sec | 5, 10, 25, 50 | 6.25, 12.5, 25, 50 |
| Channels acquired simultaneously | 12 | 12 |
| Channels printed simultaneously | 3, 6, 12 | 3, 6, 12 |
| PREVIEW SCREEN | LCD | LCD |
| NO. WAVEFORMS STORED | Optional 30, flash | Flash 25, optional 100 |
| ECG TRANSMISSION | Optional | Yes |
| Type | Fax, Programmable modem, RS232 | Programmable modem, RS232, LAN |
| INTERPRETATION | Yes | Yes |
| ECG MEASUREMENTS | Yes | Yes |
| DEFIBRILLATOR OVERLOAD PROTECTION | Yes | Yes |
| POWER REQUIREMENTS | 110-220 VAC | 115-230 VAC |
| DIMENSION, mm | 102x432x381 | 340 x 400 x 110 |
| WEIGHT, Kg | 8.5 | 5.8 |
| BATTERY OPERATION | Yes | Yes |
| Battery type | Lead acid | Built-in rechargeable NiMH |
| No. / Voltage | 1/6 | 20 / 1.2 V |
| Operating time, hours | 40 min | 5 patient monitoring / 2 printing |
| ENVIRONMENTAL | ||
| Operating temperature | +10 to +40 °C | +10 to +40 °C |
| Operating humidity (non condensing) | 25% to 75% | 25% to 75% |
| Operating altitude | 700-1060 mbar | 700-1060 mbar |
| PLANNING & PURCHASE | ||
| Warranty | 3 years in USA | 2 years in USA |
Study Information
The provided text describes a 510(k) submission, not a detailed clinical study demonstrating the performance of a novel AI/ML device against specific acceptance criteria. A 510(k) aims to establish "substantial equivalence" to a predicate device. The study that "proves the device meets the acceptance criteria" in this context is the comparison against the predicate device based on technical specifications and functional performance.
The document states: "The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices." and "After analyzing bench, electrical safety, EMC, and user testing data, it is the conclusion of Remco Italia S.p.A. that the ELAN® Digital 12 Channel Electrocardiograph is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."
1. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not explicitly stated in terms of patient ECGs. The "test set" for this type of submission generally refers to the device itself undergoing various technical and functional evaluations (bench testing, electrical safety, EMC, user testing).
- Data Provenance: Not specified as retrospectively or prospectively collected patient data. The "user testing" mentioned might involve evaluation by clinical users, but details on the data (e.g., origin, number of cases) are not provided.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) submission for an electrocardiograph. The "ground truth" for establishing substantial equivalence primarily relies on objective technical specifications and functional comparisons against the predicate device, rather than expert interpretation of a diagnostic output for a classification task. The device does perform "preliminary interpretation of ECG test" which is "offered to the physician on an advisory basis only; the physician is asked to review and validate or change the ECG interpretation," indicating that physician review (expert input) is part of its intended use but not the primary method for establishing ground truth for the 510(k) comparison.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This device is not being evaluated for a diagnostic accuracy task that would require expert adjudication of findings. Its performance is assessed against technical specifications and comparison with a predicate device.
4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device, while performing "automatic measurements of ECG waveform and preliminary interpretation," is explicitly stated as providing advisory statements that require physician review and validation. The submission does not claim to improve human reader performance but rather provides automated interpretation as an advisory tool.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device performs "automatic measurements of ECG waveform and preliminary interpretation of ECG test." This represents a form of standalone algorithmic performance. However, the regulatory submission does not detail the validation of this specific algorithmic performance against a ground truth, as it is presented as "advisory basis only" requiring physician validation. The "standalone" evaluation, in this context, is primarily against the performance characteristics of the predicate device's interpretation capabilities.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the purpose of substantial equivalence, the "ground truth" is typically the established technical and functional performance of the legally marketed predicate device. For the internal "preliminary interpretation," the document does not specify how the ground truth was established for the development of that algorithm, only that its outputs are advisory and subject to physician validation.
7. The sample size for the training set:
- Not applicable/Not provided. The document does not describe the development of a novel machine learning algorithm that would have a distinct training set. The "interpretation" functionality would have been developed based on existing ECG knowledge and algorithms, but details of a specific training set size are not part of this 510(k) submission.
8. How the ground truth for the training set was established:
- Not applicable/Not provided. As no specific training set for a novel AI/ML algorithm is described, the method for establishing its ground truth is not detailed in this document.
§ 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).