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The intended use of SE-12 series electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to 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 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 document is a 510(k) premarket notification for Electrocardiograph Models SE-12, SE-12 Express, SE-1200, and SE-1200 Express by Edan Instruments, Inc. It details the device comparison and performance data, but it does not describe specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity) for the ECG interpretation algorithm, nor does it present a study proving the device meets such criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through:

• Comparison of intended use, safety specifications, environmental specifications, and performance specifications.
• Non-clinical testing, including biocompatibility, electrical safety/EMC, bench testing against IEC standards, and software verification/validation.

Here's an analysis of the requested information based on the provided text, highlighting where information is not available:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative diagnostic acceptance criteria (e.g., minimum sensitivity or specificity for detecting heart conditions) for its ECG interpretation capabilities. The closest information is comparisons of general performance specifications with predicate devices and compliance with safety and electrical standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified for any diagnostic performance evaluation. The document states "Clinical data: Not applicable," which implies no specific clinical test set for evaluating diagnostic accuracy was used or required for this 510(k) submission.
• Data Provenance: Not applicable, as no clinical test set data is described. The device is manufactured in China (Shenzhen, P.R. China).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No clinical test set data or expert-established ground truth is described. The device's integrated interpretation uses specific algorithms (Glasgow, SEMIP) which are compared to those in predicate devices. The interpreted ECG with measurements and interpretive statements is "offered to clinicians on an advisory basis only," suggesting that the device's output is not intended as a definitive ground truth in itself.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical test set and thus no adjudication method for ground truth establishment is described.

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

• No MRMC comparative effectiveness study is mentioned. The submission states, "Clinical data: Not applicable."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• While the device includes an ECG interpretation algorithm (Glasgow/SEMIP), the document does not present a standalone performance study in terms of diagnostic accuracy (e.g., sensitivity, specificity, accuracy against a clinical gold standard). The focus is on the device's technical specifications and substantial equivalence to previously cleared devices that also include such algorithms, with the understanding that the interpretation is advisory. The "Bench Testing" (IEC 60601-2-25: 2011) primarily assesses the technical performance of the electrocardiograph (e.g., frequency response, noise, gain, etc.), not the diagnostic accuracy of its interpretive algorithm against clinical outcomes or expert diagnoses.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable for diagnostic performance. For the technical and safety performance, the "ground truth" is adherence to international and national standards (e.g., IEC 60601 series, ISO 10993-1, UL standards).

8. The sample size for the training set

• Not specified. The document describes the device as incorporating existing algorithms (Glasgow, SEMIP) found in predicate devices. Details about the training set for these algorithms (if they are considered "AI" in the modern sense) are not provided within this 510(k) summary.

9. How the ground truth for the training set was established

• Not specified. As noted above, details about the training of the Glasgow or SEMIP algorithms are not part of this submission.

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