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The Vion.ECG Pen (Model no.: 800E) is intended for recording ECG data and displaying general information by adult patients who are concerned their heart rhythm and waveform. This Vion.ECG Pen allows the patients to record transient cardiac events voluntarily for providing to the healthcare professionals as references during office visits.

In addition, the patient can also record their ECG data and transmit the recorded data to personal computer.

The Vion.ECG Pen is not intended for recording and transmission of user's ECG signal simultaneously. Users with implanted pacemakers are not recommended to use this device. This device is not intended to substitute a conventional diagnostic tool.

The MD's Vion.800E ECG Pen is a small, portable and easy-to-use electrocardiograph unit that can record and store electrocardiogram (ECG) measurements of your heart rhythm. Each ECG reading records 30 seconds measurement and these ECG readings can help your doctor monitor your condition.

The unit included build-in memory that can store up to 99 measurements, including the ECG data along with date and time of measurement. With USB interface, it allows you or your doctor to view detail information of measurement.

Furthermore, Vion® ECG Pen (Model no.: 800E) has similar general design with the Omron HCG-801 portable ECG Monitor (K060766 ) marketed by Omron Healthcare, Inc.. & MD100 Handheld ECG Monitor (K080933) marketed by Beijing Choice Electronic Technology Co., Ltd.

Here's a breakdown of the acceptance criteria and study details for the Vion® ECG Pen (Model no.: 800E), based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative "acceptance criteria" in a numerical format (e.g., specific accuracy thresholds for a diagnostic task). Instead, the clinical study's goal was to demonstrate performance "as good as" a predicate device for various ECG parameters.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 206 patients
• Data Provenance: The document does not explicitly state the country of origin. It also doesn't specify if the study was retrospective or prospective, but clinical investigations are typically prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts or their qualifications for establishing ground truth. The study design appears to use the 12-lead standard ECG (PHILIPS, PageWriter Trim II Cardiograph) as the reference for comparison, rather than an expert panel adjudicating the Vion® ECG Pen results independently.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. The study compared the Vion® ECG Pen's performance against a standard 12-lead ECG for various parameters directly.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study directly compared device performance against a predicate standard ECG, not human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the clinical investigation was a standalone device performance study. It compared the "Vion.800E" device directly against a "12-lead standard ECG" in terms of recording and displaying ECG data and various parameters. There's no mention of human interpretation or human-in-the-loop performance being part of this comparison.

7. The Type of Ground Truth Used

The ground truth or reference standard used in this study was a 12-lead standard ECG (PHILIPS, PageWriter Trim II Cardiograph).

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This suggests the study was purely a validation/comparison study, or the device does not employ machine learning that requires a separate training set.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned, there is no information on how ground truth for a training set was established.

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