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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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The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac events, suitable for hospital or home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition.

It is suitable for the adult users, who suffers from cardio-vascular diseases, or the adult people who are caring about their heart working conditions during their daily life. This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references.

The product is not a conventional diagnostic tool.

The applicant device of Handheld ECG Monitor MD100 is a handheld device, which can records cardiac event data and displays the data in a clear and precise waveform. The ECG Monitor is made up of signal input unit, signal amplify unit, CPU, Display unit, power unit, and storage chip.

The MD100 Handheld ECG Monitor is activated by the user whenever symptoms are experienced. The recorded data serves as reliable evidence and are later shown to user or physicians or other health care professionals for confirmation of these symptoms. When a user feels that a cardiac event is occurring, the utilization of MD100 has the feature of recording this real time data that is normally difficult to capture. When tested, the Heart Rate Value is displayed.

The applicant device has "data upload" function which controlled by hardware, it can transmit the data measured by the device to computer via the USB port. The software attached with the device named " Keep-it-easy" in CD ROM, which is use for store and playback the data collected by MD100 ECG monitor. The "Keep-it-Easy" software needs to install in the computer by user. The "Keep-it-Easy" software CD ROM is the accessory of the applicant device.

The applicant device has low battery voltage indication function. The power of the monitor works supplied by 2* AAA batteries.

The provided text does not contain detailed acceptance criteria or a specific study proving the device meets said criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.

Here's a breakdown of what can be extracted and what is missing, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device's ECG measurement accuracy, sensitivity, specificity, or similar. The document focuses on compliance with general safety and performance standards (IEC 60601-1, IEC 60601-1-2, AAMI EC38) and equivalence to the predicate device.
• Reported Device Performance: The document states that "Bench testing is performed to demonstrate safety and effectiveness and equivalency to the predicate device." It also mentions that the device "can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement." However, no specific performance metrics or comparative results from this bench testing are provided.

What would typically be expected for this section (but is missing):

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The Palm ECG Recorder™ Model EP-201C/202C is intended for self-testing and home health care use. The Palm ECG Recorder™ Model EP-201C/202C records, stores and transfier ECG waveforms, R-R graph and average heart rate data and presents these cardiological events in a synchronized time scale for interpretation by a physician trained in such an analysis. This is a prescription device for use only under the direction of a physician. A software user infare allows viewing. This screening tool is not intended for use as a diagnostic tool ar as a subtitute for a hospital diagnostic ECG device. This device is not intended for simulaneously recording and transmission of a user's ECG signal. This device is not recommended for use with in planted pacemakers.

The Palm ECG Recorder™, Model EP-201C/202C, is made by Parama-Tech Co., Ltd. This wireless ECG Monitor is portable, non-invasive and handheld. This is a Class II device that measures and displays EGC waveforms, R-R graph, an average heart rate along with comments. Once this device is prescribed by a physician, the Palm ECG Recorder "", can be used anytime, anywhere by anyone. This devices allows acquisition and transmission of ECG data from the user to a personal computer.

This device is suitable to detect transient symptoms that may suggest abnormal cardiac conditions to monitor cardiac conditions on a daily basis. This device is ideally suited for health care.

The provided text describes the Parama-Tech Co., Ltd. Palm ECG Recorder™, Model EP-201C/202C, and its clearance for marketing. However, the document does not contain specific acceptance criteria for performance or detailed information about a study proving the device meets such criteria in terms of clinical accuracy or effectiveness. The performance testing mentioned is limited to electrical safety, EMI/EMC, and temperature measurement accuracy, with a vague reference to "results of clinical testing" without elaboration.

Therefore, much of the requested information cannot be extracted from the provided text.

Here's an attempt to answer based on the available information:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance

• Test set sample size: Not specified.
• Data provenance: Not specified, other than "clinical testing" was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not specified. The device's intended use states that "further interpretation of ECG data recorded by Palm ECG Recorder can be sent to the prescribing physician," implying human interpretation, but this is not about ground truth establishment for a test set.

4. Adjudication method for the test set

• Not specified.

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

• Not specified. The device is a "screening device" that records and stores ECGs for physician interpretation; it does not appear to involve AI assistance for interpretation within the context of this document.

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

• Not specified. The device itself is for "self-testing and home health care use" and "records, stores and transfers ECG waveforms...for interpretation by a physician." This inherently involves a human-in-the-loop for interpretation.

7. The type of ground truth used

• Not specified.

8. The sample size for the training set

• Not applicable/Not specified. This document does not describe an AI/algorithm that would require a training set in the conventional sense for clinical performance. The "calibration" is factory-established.

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

• Not applicable/Not specified.

Summary of what the document does state regarding "performance testing":

The premarket notification for the Palm ECG Recorder™, Model EP-201C/202C, included results of testing for:

• Electrical safety
• EMI/EMC
• Temperature measurement accuracy
• "Clinical testing" (without further detail on methodology, results, or objectives)

The device is cleared as substantially equivalent to two predicate devices (Read My Heart K042814 and OMRON HCG-801 K060766), suggesting that its performance, in general, is considered comparable to these legally marketed devices based on the submitted information. However, the specific details of clinical performance acceptance criteria and proof of meeting them are not elaborated in this 510(k) summary. The emphasis appears to be on safety, technical function, and equivalence rather than a detailed clinical performance study with defined diagnostic metrics.

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