(155 days)
SE-1010 PC ECG is a PC-based diagnostic tool intended to acquire, process and store ECG Signal from adult and pediatric patients undergoing stress exercise test or resting test. SE-1010 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-1010 PC ECG can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
PC ECG is a kind of resting and exercising electrocardiograph based on PC. PC ECG including data sampling modules and software which can be installed on desktop or laptop PC. PC ECG can acquire 12 channel waveforms simultaneously, which can also print out 3/6/12 channel electrocardiograph wave simultaneously by a 210mm (A4) wide printer. Advanced digital filter technique has been used in PC ECG including baseline anti-drift filter AC noise (50/60Hz) filter; EMG Filter and Low pass Filter which can help the user to record the ECG more clearly. Moreover. the ECG Measurement and interpretation program(SEMIP) is included in this machine, this program can provide more detail information to diagnose heart disease.
The provided text
{0} to {4} gives very limited information about the acceptance criteria and study proving device performance as it's a 510(k) summary, not a full study report. The available details are almost exclusively for the device itself and its general features, not for specific algorithm performance.
Here's an analysis based on the information provided, highlighting what can be answered and what cannot:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document mentions "Software testing," "Risk analysis," "Safety testing," and "Environment test" were applied. However, no specific performance metrics (e.g., accuracy, sensitivity, specificity for interpretation) are provided as acceptance criteria or results. | |
| The device "can acquire 12 channel waveforms simultaneously." | "3/6/12-channel ECG wave display and printing simultaneously" is a feature. |
| The device "can also print out 3/6/12 channel electrocardiograph wave simultaneously by a 210mm (A4) wide printer." | "Report printing with PDF format, word format or JPG format" is a feature. |
| Advanced digital filter technique has been used, including baseline anti-drift filter AC noise (50/60Hz) filter, EMG Filter and Low pass Filter. | These filters are listed as being included. |
| The ECG Measurement and interpretation program (SEMIP) is included. | This program "can provide more detail information to diagnose heart disease." "Supporting auto measurement and diagnosing" is a feature. |
| The device is intended to acquire, process and store ECG signals from adult and pediatric patients. | No specific performance metrics for this are given. |
| The device recorded cardiogram can help users to analyze and diagnose heart disease. | The interpretive statements are "offered to clinicians on an advisory basis only." |
Study Details
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Sample size used for the test set and the data provenance: Not available. The document only states "Verification and validation testing was done on PC ECG" but provides no details on the test set, its size, or its origin.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. There is no information regarding ground truth establishment for a test set.
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Adjudication method for the test set: Not available. No details about a test set or its adjudication are provided.
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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 available. The submission does not mention an MRMC study or any comparison of human readers with vs. without AI assistance. The interpretation program "is offered to clinicians on an advisory basis only," suggesting it's a tool, not a replacement or direct comparison to human reading in this context.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly stated/detailed. While the device includes an "ECG Measurement and interpretation program (SEMIP)" that supports "auto measurement and diagnosing," no standalone performance metrics for this algorithm are provided (e.g., diagnostic accuracy, sensitivity, specificity for specific conditions). The statement that these interpretations are "advisory" further suggests that rigorous standalone performance was not the primary focus of the 510(k) summary for interpretative accuracy.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available. Information on how ground truth was established for any performance evaluation is not provided.
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The sample size for the training set: Not available. There is no information about a training set.
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How the ground truth for the training set was established: Not available. There is no information about a training set or its ground truth establishment.
Summary of Limitations:
This 510(k) summary focuses on the safety and effectiveness (substantial equivalence) of the PC ECG device, rather than detailed performance metrics of its interpretive algorithms. It largely describes the device's features and general testing (software, risk, safety, environment). For an interpretive ECG device, a full study report would typically include detailed performance characteristics like sensitivity, specificity, and accuracy for various ECG findings, often compared against a gold standard established by expert cardiologists. This information is absent from the provided 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).