(45 days)
The intended use of LE-12CH electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 vears of age) through body surface FCG electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healtheare 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.
CAF Medical's LE-12CH electrocardiograph device is a twelve-channel electrocardiograph, which features a user-friendly design, a high-resolution 8.4-inch (800*600) TFT LCD touch screen, an alphanumeric keypad and an optimized workflow.
The LE-12CH electrocardiograph can acquire 12-channel waveforms simultaneously, and can also print the 12-channel electrocardiograph waveforms simultaneously, using a 216 mm wide thermal printer.
An advanced digital filtering technique has been used in the LE-12CH device, including a baseline anti-drift filter, AC noise filter (50/60 Hz), EMG filter and low-pass filter, which can help the user record the ECG more clearly.
The LE-12CH electrocardiograph works by sampling the ECG signal from the patient's skin surface using special electrodes. This signal is then amplified and sampled in A/D format by the ECG board. The ECG board transfers the data to the system's MCU via UART. The MCU filters the data, sends it to the LCD, prints the waveforms on paper and stores the data in memory. This log can be stored in flash memory or sent to the PC via Ethernet, WIFI or RS232. During the examination, no substances are given to or removed from the patient. The LE-12CH electrocardiograph supports cardiac stress testing.
Here's an analysis of the provided text regarding the acceptance criteria and study for the LE-12CH device:
Based on the provided FDA 510(k) summary for the LE-12CH Electrocardiograph, the submission primarily relies on demonstrating substantial equivalence to a predicate device (K171942. Electrocardiograph with models SE-12, SE-12 Express, SE-1200 and SE-1200 Express. Edan Instruments, Inc.). This means the acceptance criteria are largely aligned with proving that the LE-12CH performs as safely and effectively as the predicate device based on common industry standards and performance specifications.
The document does not describe a specific clinical study (like an MRMC study or standalone algorithm performance study with a test set and ground truth) in the way one might expect for a novel AI/ML-driven diagnostic device. Instead, it details non-clinical testing to ensure compliance with relevant performance and safety standards, and then performs a comparison to the predicate device's specifications.
Therefore, many of the requested fields regarding detailed study methodology (sample size, data provenance, expert consensus, adjudication, effect size) are not applicable in the context of this 510(k) submission as it focuses on demonstrating equivalence through non-clinical means and direct comparison of specifications.
Here's the breakdown of the information that can be extracted or inferred:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the safety and performance standards the device was tested against and by the specifications matching the predicate device. The "reported device performance" is essentially that it meets these standards and matches the predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety Standards Compliance | Meets IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25. |
| Anti-electric-shock type | Class I with internal power supply (Same as predicate) |
| Anti-electric-shock degree | Type CF (Same as predicate) |
| Degree of protection against harmful ingress of water | Ordinary equipment (Sealed equipment without liquid proof) (Same as predicate) |
| Disinfection/sterilization method | Refer to the user manual for details (Same as predicate) |
| Degree of safety of application in presence of flammable gas | Equipment not suitable for use in the presence of flammable gas (Same as predicate) |
| Working mode | Continuous operation (Same as predicate) |
| EMC | CISPR 11 Group 1, Class A (Same as predicate) |
| Ingress rating | IPX0 (Same as predicate) |
| Environmental Specifications | |
| Temperature (Transport & Storage) | -20ºC (-4ºF) ~ +55ºC (+131ºF) (Same as predicate) |
| Temperature (Working) | +5ºC (+41ºF) ~ +40ºC (+104ºF) (Same as predicate) |
| Relative Humidity (Transport & Storage) | 25%~93% Non-Condensing (Same as predicate) |
| Relative Humidity (Working) | 25% RH ~ 80% RH Non-Condensing (Same as predicate) |
| Atmospheric Pressure (Transport & Storage) | 700 hPa ~1060 hPa (Same as predicate) |
| Atmospheric Pressure (Working) | 860 hPa ~1060 hPa (Same as predicate) |
| Power Supply Specifications | |
| Mains Supply (Operating Voltage, Frequency, Input Current/Power) | 100V-240V~, 50 Hz / 60 Hz, 0.9-0.4A / 96VA (Same as predicate) |
| Built-in Lithium Battery Pack (Rated voltage) | 14.8 V (Same as predicate) |
| Built-in Lithium Battery Pack (Rated capacity) | 5000mAh (Matching the higher capacity predicate model, SE-12 Express & SE-1200 Express) |
| Battery working duration | ~5 hours, ~2.5 hours continuous print (manual), ~350 ECG reports (auto) (Matching the higher-performing predicate model, SE-12 Express & SE-1200 Express) |
| Performance Specifications | |
| Recorder (Type) | Thermal dot-matrix recorder (Same as predicate) |
| Printing Density | 8 dots per mm / 200 dots per inch (amplitude axes), 40 dots per mm / 1000 dots per inch (time axes, @25mm/s) (Same as predicate) |
| Recorder Paper (Types) | Folded thermal paper: 210mm×295mm×100pages, 215mm×280mm×100pages (Optional); Rolled thermal paper: 210mm×30m (Optional) (Same as predicate) |
| Effective Width | 210mm (Same as predicate) |
| Paper Speed | 5mm/s, 6.25mm/s, 10mm/s, 12.5mm/s, 25mm/s, 50mm/s (±3%) (Same as predicate) |
| Accuracy of data | ±5% (x-axis), ±5%(y-axis) (Same as predicate) |
| HR Recognition (Technique) | Peak-Peak Detection (Same as predicate) |
| HR Range | 30 BPM ~ 300 BPM (Same as predicate) |
| HR Accuracy | ±1 BPM (Same as predicate) |
| Leads | Standard 12 leads (Same as predicate) |
| Acquisition Mode | Simultaneously 12 leads (Same as predicate) |
| A/D Resolution | 24 bits (Same as predicate) |
| Resolution | 2.52uV/LSB (Same as predicate) |
| Time Constant | ≥ 3.2 s (Same as predicate) |
| Frequency Response | 0.01Hz ~ 300 Hz (-3 dB) (Same as predicate) |
| Gain | 1.25,2.5, 5, 10, 20, 10/5, AGC (mm/mV) (Same as predicate) |
| Input Impedance | ≥100MΩ(10Hz) (Same as predicate) |
| Input Circuit Current | ≤0.01μA (Same as predicate) |
| Input Voltage Range | ≤±5 mVpp (Same as predicate) |
| Calibration Voltage | 1mV±2% (Same as predicate) |
| DC Offset Voltage | ±600 mV (Same as predicate) |
| Noise | ≤12.5 µVp-p (Same as predicate) |
| Multi-channel Crosstalk | ≤0.5 mm (Same as predicate) |
| Filter (AC, EMG, Lowpass) | Match predicate specifications (AC: On/Off; EMG: 25Hz/35Hz/45Hz/OFF; LOWPASS: 300Hz/270Hz/150Hz/100Hz/75Hz) |
| CMRR | ≥140dB (AC ON), ≥123dB (AC OFF) (Same as predicate) |
| Sampling Frequency | 16000Hz (Same as predicate) |
| Pacemaker Detection (Amplitude, Width, Sampling Frequency) | Match predicate specifications (Amplitude: ±750uV to ±700 mV; Width: 50μs to 2.0 ms; Sampling Frequency: 16,000/sec/channel) |
| Input | ≥100 kΩ; Sensitivity 10 mm/V±5%; Single ended (Same as predicate) |
| Output | ≤100Ω; Sensitivity 1 V/mV ±5%; Single ended (Same as predicate) |
| Biocompatibility Standards | Compliant with ISO 10993-1, ISO 10993-5, ISO 10993-10. |
| Software Validation Guidance | Compliant with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Level of Concern "Moderate"." |
Study Details (as per request, with N/A for non-applicable fields)
-
Sample size used for the test set and the data provenance:
- Not Applicable. The submission does not describe a clinical "test set" in the context of an algorithm's performance evaluation with patient data. It relies on non-clinical testing against standards and direct comparison of technical specifications to a predicate device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no clinical test set requiring expert ground truth was documented, this information is not provided. The device includes "interpreted ECG with measurements and interpretive statements... Offered to clinicians on an advisory basis only," indicating that the device's interpretation is assistive and not designed to replace expert diagnosis directly without human review.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set with human adjudication was described.
-
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. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the subject device to the predicate device." Therefore, no MRMC study was conducted or reported.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, not in the sense of a clinical performance study. The device itself is an electrocardiograph that acquires and processes ECG signals, providing interpreted ECG with measurements and interpretive statements. This processing is inherent to the device's function, but its "standalone performance" isn't evaluated as a diagnostic algorithm through a dedicated clinical study with ground truth. Its performance is demonstrated by meeting IEC standards and matching the predicate's technical specifications. The interpretations are explicitly "advisory only."
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For the purpose of this 510(k), ground truth for specific disease diagnoses from patient data was not established or used to evaluate the device's interpretive statements in a clinical performance study. The "ground truth" here is compliance with established engineering and safety standards (e.g., accuracy of heart rate detection against known input signals, filter performance) and the technical specifications of a legally marketed predicate device.
-
The sample size for the training set:
- Not Applicable. The document provides no information on a training set, as it does not describe a machine learning algorithm that requires training data. The device's "advanced digital filtering technique" is a more traditional signal processing methodology, not explicitly stated as an AI/ML algorithm requiring a training set for its interpretive functionality.
-
How the ground truth for the training set was established:
- Not Applicable. As there is no described training set, this information is not provided.
§ 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).