(163 days)
SE-1515 PC ECG is intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. The SE-1515 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the SE-1515 PC ECG can help users to analyze and diagnose heart diseases. However, the ECG with measurements is offered to clinicians on an advisory basis only. It is mainly used in the ECG Outpatient Department and Physical Examination Department.
SE-1515 is a PC-based ECG designed to acquire, process and store ECG signals and analyze and diagnose heart disease. SE-1515 consists of analysis software and sampling boxes, and has four configurations: Wired 18-lead ECG system, Wired 16-lead ECG system, Wired 12-lead ECG system and Wireless 12-lead ECG system. Wired 18-lead ECG system consists of analysis software and wired DE18 sampling box. Wired 16-lead ECG system consists of analysis software and wired DE15 sampling box. Wired 12-lead ECG system consists of analysis software and wired DP12 sampling box. Wireless 12-lead ECG system contains analysis software, wireless DX12 sampling boxes (DX12 transmitter and DX12 receiver). The communication between DX12 transmitter and DX12 receiver is based on Bluetooth technology. For stress exercise testing, the user should connect a BP monitor and a treadmill or an ergo meter to the PC.
Here's a breakdown of the acceptance criteria and the study information for the EDAN Instruments, Inc. PC ECG, model SE-1515, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating
substantial equivalence to predicate devices, not necessarily a detailed clinical
effectiveness study itself. Therefore, specific details about acceptance criteria, ground truth
establishment (especially for a new algorithm), and effect sizes from MRMC studies are often
not explicitly stated in this type of document. The information below is extracted directly
from the text; if a point is not mentioned, it's because the document does not provide it.
Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" but rather compares the performance parameters of the SE-1515 with its predicate devices (SE-1010, Philips DXL 12/16-lead ECG Algorithm, Philips TC70). The implicit acceptance criteria are that the new device's performance should be similar or comparable to the predicate devices, or that any differences do not raise new questions of safety or effectiveness.
Below is a table summarizing the performance comparison, highlighting where quantitative parameters are presented. Since "Remark" column indicates "Same," "Different," or "---", for the purpose of showing "acceptance criteria" and "reported device performance", the "predicate value" can be considered as the implicit acceptance criteria that the new device needs to meet to establish substantial equivalence.
| Item (Device Component) | Acceptance Criteria (Predicate Value, where applicable) | Reported Device Performance (SE-1515) |
|---|---|---|
| DE15 Sampling Box | ||
| DFT Filter | weak/strong | 0.01 Hz/0.05 Hz/0.32 Hz/0.67 Hz |
| Low Pass/EMG Filter | 25 Hz/35 Hz/45 Hz/75 Hz/100 Hz/150 Hz | 300 Hz/270 Hz/150 Hz/100 Hz/75 Hz (Low Pass Filter); 25 Hz/35 Hz/45 Hz/Off (EMG Filter) |
| Lead number | 12-lead | 16-lead |
| Sampling Rate | 1 kHz /channel | 16 kHz /channel |
| Resolution | 2.52 µV/LSB @ 1 kHz | 0.1575 µV/LSB @ 1 kHz |
| Frequency Response | 0.05 Hz ~ 150 Hz | 0.01 Hz~300 Hz |
| Input Impedance | >50 MΩ | ≥100 MΩ |
| Common Mode Rejection | >110 dB | ≥140 dB(AC ON) / ≥123 dB(AC OFF) |
| Pace Detect | ±2 to ±700 mV @ 0.1 ms to 2.0 ms | ±750 uV~±700 mV @ 50 us ~2.0 ms |
| DE18 Sampling Box | ||
| DFT Filter | weak/strong | 0.01 Hz/0.05 Hz/0.32 Hz/0.67 Hz |
| Low Pass/EMG Filter | 25 Hz/35 Hz/45 Hz/75 Hz/100 Hz/150 Hz | 300 Hz/270 Hz/150 Hz/100 Hz/75 Hz (Low Pass Filter); 25 Hz/35 Hz/45 Hz/Off (EMG Filter) |
| Lead number | 12-lead | 18-lead |
| Sampling Rate | 1 kHz /channel | 16 kHz /channel |
| Resolution | 2.52 µV/LSB @ 1 kHz | 0.1575 µV/LSB @ 1 kHz |
| Frequency Response | 0.05 Hz ~ 150 Hz | 0.01 Hz~300 Hz |
| Input Impedance | >50 MΩ | ≥100 MΩ |
| Common Mode Rejection | >110 dB | ≥140 dB (AC ON) / ≥123 dB (AC OFF) |
| Pace Detect | ±2 to ±700 mV @ 0.1 ms to 2.0 ms | ±750 uV~±700 mV @ 50 us ~2.0 ms |
| DP12 Sampling Box | ||
| Sampling Rate | 1,000 /sec/channel | 1,000 /sec/channel |
| Resolution | 2.52 µV/LSB @ 1 kHz | 2.52 µV/LSB @ 1 kHz |
| Time Constant | ≥3.2 s | ≥3.2 s |
| Frequency Response | 0.05 Hz ~ 150 Hz (-3 dB) | 0.05 Hz ~ 150 Hz (-3 dB) |
| Input Impedance | >50 MΩ @ 10 Hz, defibrillator protected | >50 MΩ @ 10 Hz, defibrillator protected |
| Dynamic Range | AC Differential ± 5 mV, DC offset ±600 mV | AC Differential ± 5 mV, DC offset ±600 mV |
| System Noise | ≤12.5 µVp-p | ≤12.5 µVp-p |
| Common Mode Rejection | >110 dB | >110 dB |
| Pace Detect | ±2 to ±700 mV@0.1 to 2.0 ms | ±2 to ±700 mV@0.1 to 2.0 ms |
| ESD Sensitivity | ±6 kV contact / ±8 kV air | ±6 kV contact / ±8 kV air |
| Heart Rate Meter | 30 BPM ~300 BPM, ±1 BPM | 30 BPM ~300 BPM, ±1 BPM |
| DX12 Sampling Box | ||
| All listed parameters (Sampling Rate, Resolution, Time Constant, Frequency Response, Input Impedance, Dynamic Range, System Noise, Common Mode Rejection, Pace Detect, ESD Sensitivity, Heart Rate Meter, Transmitting Frequency, Frequency Band, Modulation Type, Transmitting Power) | Matches predicate | Matches predicate |
| Analysis Software | ||
| Operating system | Windows XP SP2/SP3, Vista, Windows 7 | Windows XP SP2/SP3 (32/64 bit), Windows 7 SP1 (32/64 bit) or Windows 8 (32/64 bit) |
Study Information:
-
Sample size used for the test set and the data provenance:
- The document mentions "database testing" for ECG interpretation features but does not specify the sample size for this test set or the provenance (country of origin, retrospective/prospective nature) of the data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The document refers to "ECG interpretation features... validated by database testing," but details on the ground truth establishment for this validation are absent.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
-
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:
- An MRMC comparative effectiveness study, particularly one measuring human reader improvement with AI assistance, was not indicated. The comparison is mainly against predicate devices, focusing on technical specifications and substantial equivalence, not algorithm-assisted human reading.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The document states, "ECG interpretation features were also validated by database testing." This implies a standalone performance evaluation of the algorithm against a database, though details are missing. The device's indications for use also state that the "ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only," suggesting a standalone interpretive function.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "ECG interpretation features," the document mentions "database testing." However, the specific type of ground truth used within this database (e.g., expert consensus diagnoses, correlation with patient outcomes, or other clinical data) is not specified.
-
The sample size for the training set:
- The document does not specify a training set and its size. The validation focuses on the device's performance and ECG interpretation features using "database testing."
-
How the ground truth for the training set was established:
- Since no training set is explicitly mentioned or described, the method for establishing its ground truth is also 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).