(60 days)
The SE-18 18-lead electrocardiograph is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
The SE-18 acquires and displays an 18 leads waveforms, which can also be printed by an integrated thermal printer with effective recording width 216mm. Digital filtering techniques similar to those incorporated on the SE-1515 and SE-12 have been used in SE-18: including Anti-baseline drift filter, AC filter (50/60Hz), EMG Filter and Low pass Filter, which can help the user to record a higher quality ECG. The EDAN Instruments "Smart ECG Measurement and interpretation program" (SEMIP) is included in this machine. The SEMIP program is completely integrated and provides the clinician with a detailed analysis of the ECG signal to aid in the interpretation of the ECGs. The recorded ECG can be saved in flash memory or sent to a PC by Ethernet or WIFI. During the examination, there are no substances delivered to and/or extracted from the patient. SE-18's function block diagram is shown as Fig 1. It's made up of an external ECG Sampling Box, SE-18 Main Control Board with RAM, FLASH, Ethernet module, WIFI module and USB module, a thermal printer module, a power supply module, a keyboard, and 15' 1024*768 display module.
The provided text describes the 510(k) submission for the Edan Instruments, Inc. SE-18 Electrocardiograph. It establishes substantial equivalence to predicate devices (EDAN Instrument, Inc. Electrocardiograph, models SE-1515 and SE-12 Series) based on similar design features, performance specifications, and non-clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" in the format of pass/fail thresholds against which device performance is directly measured. Instead, it compares the specifications of the proposed device (SE-18) against the predicate devices (SE-1515 and SE-12 Series) in a series of tables. The acceptance criteria are implicitly met if the proposed device's performance characteristics are "Same" as or demonstrate "minor differences" that "do not raise different questions of safety or effectiveness" compared to the predicate devices.
Below is a summary drawn from the provided comparison tables, focusing on a few key performance parameters. It consolidates information from Tables 1 and 2-2.
| Performance Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (SE-18) | Outcome (compared to Predicate) |
|---|---|---|---|
| HR Recognition | |||
| HR Range | 30 bpm ~300 bpm | 30 bpm ~300 bpm | Same |
| Accuracy | ± 1 bpm | ± 1 bpm | Same |
| ECG Unit (Electrical) | |||
| Leads | 18 standard leads (SE-1515); Standard 12 leads (SE-12 Series) | 18 standard leads | Same (vs. SE-1515) / Different (vs. SE-12 Series, with explanation below) |
| Sampling Frequency | 16kHz (SE-1515); 10k Hz (SE-12 Series) | 16kHz | Same (vs. SE-1515) / Different (vs. SE-12 Series) |
| A/D | 24 bits | 24bits | Same |
| Resolution | 0.1575uV/LSB (SE-1515); 2.52uV/LSB (SE-12 Series) | 0.1575 μV/LSB | Same (vs. SE-1515) / Different (vs. SE-12 Series) |
| Frequency Response | 0.01~300Hz(-3dB) (SE-1515); 0.05 Hz ~ 150 Hz (-3 dB) (SE-12 Series) | 0.01~300Hz(-3dB) | Same (vs. SE-1515) / Different (vs. SE-12 Series) |
| Input Impedance | ≥100MΩ (10Hz) (SE-1515); ≥50 MΩ(10 Hz) (SE-12 Series) | ≥100M Ω (10Hz) | Same (vs. SE-1515) / Different (vs. SE-12 Series) |
| Noise | ≤12.5µVp-p | ≤12.5μVp-p | Same |
| Multichannel Crosstalk | ≤0.5mm | ≤0.5mm | Same |
| Filters | |||
| DFT Filter settings | 0.01Hz/0.05Hz/0.32Hz/0.67Hz (SE-1515); 0.05Hz / 0.15Hz / 0.25Hz / 0.32Hz / 0.5Hz / 0.67Hz (SE-12 Series) | 0.01Hz/0.05Hz/0.32Hz/0.67Hz | Same (vs. SE-1515) / Different (vs. SE-12 Series) |
| Lowpass Filter settings | 300Hz/270Hz/150Hz/100Hz/75Hz (SE-1515); 150Hz / 100Hz / 75Hz (SE-12 Series) | 300Hz/270Hz/150Hz/100Hz/75Hz | Same (vs. SE-1515) / Different (vs. SE-12 Series) |
| CMRR | ≥123dB (AC OFF) (SE-1515); ≥115dB (AC Off) (SE-12 Series) | ≥140dB (AC On), ≥123dB (AC Off) | Greater than (vs. SE-12 Series) / Same (vs. SE-1515 for AC Off) |
| Pacemaker Detection | |||
| Amplitude | ±750μV to ±700mV (SE-1515); ±2 to ±700 mV (SE-12 Series) | ±750μV to ±700mV | Same (vs. SE-1515) / Different (vs. SE-12 Series) |
| Width | 50us to 2.0ms (SE-1515); 0.1 to 2.0 ms (SE-12 Series) | 50µs to 2.0ms | Same (vs. SE-1515) / Different (vs. SE-12 Series) |
The document states that SE-18 has "minor differences" compared to the predicate devices and that these "do not raise different questions of safety or effectiveness." This implies that the observed differences are within acceptable limits or represent improvements that do not negatively impact safety or effectiveness.
2. Sample size used for the test set and the data provenance
The document explicitly states "Clinical data: Not applicable."
For non-clinical data, it mentions Bench Testing was conducted per IEC 60601-2-25: 2011, and "all the results show pass." However, specific sample sizes for this general bench testing are not provided. The data provenance is not mentioned beyond being part of the manufacturer's internal testing. It is retrospective, as it was submitted for a 510(k) premarket notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical study or expert-based ground truth establishment is described for the device's performance other than that the device's interpretation statements are "offered to clinicians on an advisory basis only." For the safety and performance testing, standards like IEC 60601-1 and IEC 60601-2-25 are used, which do not typically involve human expert consensus for ground truth on device specifications like sampling frequency or input impedance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no described clinical study involving assessment by human readers requiring adjudication.
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
Not applicable. The document states "Clinical data: Not applicable" and describes an electrocardiograph, not an AI-assisted diagnostic tool requiring an MRMC study. The "EMIP" program for interpretation is mentioned, but its effectiveness or impact on human readers is not studied or presented here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device includes the "EDAN Instruments 'Smart ECG Measurement and interpretation program' (SEMIP)". While this is an algorithm, the document does not describe a standalone performance study of SEMIP's diagnostic accuracy. It states that "the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only," suggesting it's not intended for standalone diagnostic use. The focus is on the device's hardware and basic signal acquisition/processing capabilities meeting predicate equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance and safety specified, the ground truth is based on engineering specifications and adherence to international standards (e.g., IEC 60601-1, IEC 60601-2-25). For the SEMIP program, no explicit ground truth methodology for its interpretive statements is provided in this submission summary. Given its "advisory basis only" role, a rigorous ground truth validation for diagnostic accuracy might not have been required for this 510(k).
8. The sample size for the training set
Not applicable. The document does not describe a machine learning model that would require a training set. The SEMIP program is mentioned, but details on its development data or training set are not provided.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning model is described in the 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).