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SE-12 series is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. SE-12 series is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-12 series can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

SE-12 series is 12-channel electrocardiograph, it contains four models:SE-12/SE-1200/SE-12Express/SE-1200Express. These four models include the same ECG board, power supply board and main controlling board. The software and function of these four models are similar, except that SE-12Express has the optional function which include stress exercise test. SE-12 series can acquire 12 channel waveforms simultaneously, which can also print out 12 channel electrocardiograph wave simultaneously by a 216mm wide thermal printer, and the waveforms also can be displayed in LCD and stored in flash memory or send to PC by RS232 or Ethernet.

This document is a 510(k) summary for the Edan Instruments SE-12 series Electrocardiograph, a Class II medical device. It outlines the device's description, intended use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria, detailed performance metrics, or a dedicated study section that directly addresses the acceptance criteria in the manner requested. The document primarily focuses on establishing substantial equivalence to previously cleared devices.

Based on the provided text, here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

The provided 510(k) summary does not explicitly list acceptance criteria with corresponding performance statistics. Instead, it relies on a "Test Summary" stating: "The following quality assurance measures were applied to the development of the SE-12 series: Software testing, Risk analysis, Safety testing, Environment test." It concludes: "Verification and validation testing was done on SE-12 series. This premarket notification submission demonstrates that SE-12 series is substantially equivalent to the predicate device."

To fulfill this request fully, detailed performance specifications and acceptance criteria would typically be found in the full 510(k) submission, not just the summary. Without that, we can only infer that the acceptance criteria revolved around meeting safety, performance, and functional requirements comparable to the predicate devices.

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

The document does not specify the sample size used for any test sets, nor does it provide information on the data provenance (e.g., country of origin, retrospective/prospective nature).

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)

The document does not mention the number or qualifications of experts used to establish ground truth for any test set. The intended use states that the interpreted ECG is "offered to clinicians on an advisory basis only," implying human expert review is still central to diagnosis, but it doesn't detail how ground truth was established for testing the device's interpretation function itself.

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

The document does not describe any adjudication method for a test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device, an electrocardiograph, pre-dates widespread AI interpretation in medical devices, dating back to 2010. Its interpretation function is likely rule-based rather than AI-driven.

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

The document states that the "interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only." This clearly indicates that the device's interpretation function is not intended for standalone use in diagnosis and requires human-in-the-loop performance. Therefore, a standalone performance study in the context of diagnostic interpretation is not implied or described. The "Test Summary" only mentions general software, risk, safety, and environment testing.

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

The document does not specify the type of ground truth used for any testing. Given the "advisory basis" for interpretation, it's highly likely that if interpretation accuracy was assessed, it would have been against expert consensus readings, but this is not explicitly stated.

8. The sample size for the training set

The document does not provide information regarding a training set sample size. This is consistent with the device being from 2010 and its interpretation likely relying on rule-based algorithms rather than machine learning models that require explicit training sets in the modern sense.

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

Since there is no mention of a training set, the document does not describe how ground truth for a training set was established.

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