(210 days)
The intended use of SE-12 series electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface ECG 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 disease. However, the interreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
The SE-12/12 Express/1200/1200 Express Electrocardiograph gathers ECG signals of 12 leads simultaneously. It displays the operation menu, ECG parameters as well as electrocardiograms, and be powered by the mains supply or battery. And the system has advanced performance and high reliability due to high resolution thermal recorder, 32-bit processor and a large-capacity memorizer. Design of the system took much consideration on ergonomics so the size is suitable for clinic and hospital uses.
There are four selectable modes in the system, including manual, auto, rhythm, R-R analysis or VCG, and VCG is configured with SE-12 Express & SE-1200 Express.
SE-12 and SE-1200 share the same single-color LCD screen of which the resolution is 320×240 dot; and LCD screen of SE-12 Express and SE-1200 Express is 800×600 multicolor LCD screen.
Moreover, SE-12 Express is configured with stress ECG function, which will allow to diagnose concealed coronary heart disease and atypical angina pectoris, prescribe the workload for patients with myocardial infarction before leaving hospital, and assess the effect of the treatment.
The provided text describes a 510(k) premarket notification for an Electrocardiograph device (models SE-12, SE-12 Express, SE-1200, and SE-1200 Express). It does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/algorithm's performance. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical data and comparisons of technical specifications.
Therefore, many of the requested items related to an AI study, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not available in the provided text.
However, I can extract the acceptance criteria and performance information that is available, which pertains to the device's general technical specifications and safety/EMC standards.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the "Same" or "Different" comparison to the predicate device for various specifications, as well as compliance with relevant standards. The reported device performance is either identical to the predicate (marked as "Same") or an improved/different specification (marked as "Different").
Note: The "Comparison Result" column indicates if the proposed device's specification is "Same" or "Different" from the predicate. When "Different," the proposed device's performance is listed.
| Acceptance Criteria Category | Specific Metric | Device Performance (Proposed Device) | Comparison Result (vs Predicate) |
|---|---|---|---|
| Intended Use | Patient Age Range | Adult and pediatric patient (beginning at birth through 21 years of age) | Different |
| Safety Specifications | Safety Standards Compliance | IEC 60601-1:2005/A1:2012, EN 60601-1:2006/A1:2013, IEC 60601-1-2:2007, EN 60601-1-2:2007/AC:2010, IEC/EN 60601-2-25 | Same |
| Anti-electric-shock type | Class I with internal power supply | Same | |
| Anti-electric-shock degree | Type CF | Same | |
| Degree of protection against harmful ingress of water | Ordinary equipment (Sealed equipment without liquid proof) | Same | |
| Disinfection/sterilization method | Refer to the user manual for details | Same | |
| Degree of safety in flammable gas presence | Equipment not suitable for use in the presence of flammable gas | Same | |
| Working mode | Continuous operation | Same | |
| EMC | CISPR 11 Group 1, Class A | Same | |
| Ingress rating | IPX0 | Same | |
| Environmental Specs | Transport & Storage Temperature | -20°C (-4°F) ~ +55°C (+131°F) | Same |
| Working Temperature | +5°C (+41°F) ~ +40°C (+104°F) | Same | |
| Transport & Storage Relative Humidity | 25%~93% Non-Condensing | Same | |
| Working Relative Humidity | 25% RH ~ 80% RH Non-Condensing | Same | |
| Transport & Storage Atmospheric Pressure | 700 hPa ~1060 hPa | Same | |
| Working Atmospheric Pressure | 860 hPa ~1060 hPa | Same | |
| Power Supply Specs | Mains Supply Operating Voltage | 100V-240V~ | Same |
| Mains Supply Operating Frequency | 50 Hz / 60 Hz | Same | |
| Mains Supply Input Current | 0.9-0.4A | Same | |
| Mains Supply Input Power | 96VA | Same | |
| Battery Pack Rated Voltage | 14.8 V | Same | |
| SE-12 Express & SE-1200 Express Battery Capacity | 5000mAh | Same | |
| SE-12 & SE-1200 Battery Capacity | 2500mAh | Same | |
| Battery Work Time (Full Charge, SE-12 & SE-1200) | Approx. 4 hours normally; approx. 1.5 hours continual print (manual); approx. 300 ECG reports (auto, 3x4+1R) | Same | |
| Battery Work Time (Full Charge, SE-12 Express & SE-1200 Express) | Approx. 5 hours normally; approx. 2.5 hours continual print (manual); approx. 350 ECG reports (auto, 3x4+1R) | Same | |
| Performance Specs | Recorder Type | Thermal dot-matrix recorder | Same |
| Printing Density (amplitude axes) | 8 dots per mm / 200 dots per inch | Same | |
| Printing Density (time axes, @ 25mm/s) | 40 dots per mm / 1000 dots per inch | Same | |
| Recorder Paper (Folded Thermal) | 210mm×295mm×100pages OR 215mm×280mm×100pages (Optional) | Same | |
| Recorder Paper (Rolled Thermal) | 210mm×30m (Optional) | Same | |
| Effective Width | 210mm | Same | |
| Paper Speed | 5mm/s, 6.25mm/s, 10mm/s, 12.5mm/s, 25mm/s, 50mm/s (±3%) | Same | |
| Accuracy of data | ±5% (x-axis), ±5% (y-axis) | Same | |
| HR Recognition Technique | Peak-Peak Detection | Same | |
| HR Range | 30 BPM ~ 300 BPM | Same | |
| HR Accuracy | ±1 BPM | Same | |
| ECG Unit Leads | Standard 12 leads | Same | |
| Acquisition Mode | Simultaneously 12 leads | Same | |
| A/D Resolution | 24 bits | Same | |
| Resolution | 2.52uV/LSB | Same | |
| Time Constant | ≥ 3.2 s | Same | |
| Frequency Response | 0.01Hz ~ 300 Hz (-3 dB) | Different | |
| Gain | 1.25, 2.5, 5, 10, 20, 10/5, AGC (mm/mV) | Same | |
| Input Impedance | ≥100MΩ (10Hz) | Different | |
| Input Circuit Current | ≤0.01μA | Same | |
| Input Voltage Range | ≤±5 mVpp | Same | |
| Calibration Voltage | 1mV±2% | Same | |
| DC Offset Voltage | ±600 mV | Same | |
| Noise | ≤12.5 µVp-p | Same | |
| Multi-channel Crosstalk | ≤0.5 mm | Same | |
| Filter (AC Filter) | On / Off | Same | |
| Filter (DFT Filter) | 0.01Hz/0.05Hz / 0.15Hz / 0.25Hz / 0.32Hz / 0.5Hz / 0.67Hz | Different | |
| Filter (EMG Filter) | 25Hz / 35Hz / 45Hz / OFF | Same | |
| Filter (LOWPASS Filter) | 300Hz/270Hz/150Hz / 100Hz / 75Hz | Different | |
| CMRR | ≥140dB (AC ON), ≥123dB (AC OFF) | Different | |
| Sampling Frequency | 16000Hz | Different | |
| Pacemaker Detection | Amplitude | ±750uV to ±700 mV | Different |
| Width | 50µs to 2.0 ms | Different | |
| Sampling Frequency | 16,000/sec/channel | Different | |
| External Input/output | Input | ≥100 kΩ; Sensitivity 10 mm/V±5%; Single ended | Same |
Study Details (Information Not Available in the Provided Text)
The document is a 510(k) summary for a medical device (Electrocardiograph) seeking substantial equivalence to a previously cleared predicate device. It primarily focuses on hardware specifications, safety, EMC, and software verification/validation. It does not describe a study involving an AI or algorithm's diagnostic performance beyond stating that "ECG interpretation features were also validated by database testing." As such, the following requested information is not explicitly detailed in the provided text:
- Sample size used for the test set and the data provenance: Not explicitly stated for specific diagnostic performance of the interpretation features, beyond "database testing."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not stated.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not stated.
- 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 MRMC study is mentioned. The device's interpreted ECG with statements is "offered to clinicians on an advisory basis only," indicating it's an assistive tool, but no comparative effectiveness study with human readers is described.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document mentions "ECG interpretation features were also validated by database testing," which suggests standalone algorithm testing, but details on its specific performance metrics (e.g., sensitivity, specificity, accuracy) are not provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not stated for the "database testing" of interpretation features.
- The sample size for the training set: Not stated.
- How the ground truth for the training set was established: Not stated.
The document primarily demonstrates that the updated hardware and software of the Electrocardiograph maintain the safety and effectiveness profile of its predicate device, rather than providing a detailed study of an AI's diagnostic performance against specific acceptance criteria.
§ 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).