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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 Handheld ECG Monitor MD100 is intended for use in non-invasive recording and displaying ECG waveform by adult patients. It addition, it also can provide to the treating physician with relevant data on the cardiac rhythm in hospital patients. It is immediately available at any time to manually record transient cardiac events. suitable for patient and professional use, helpful in determining the cardiac rhythm at the time of symptoms. This ECG monitor allows the patient to record their ECG data into the device memory for display by healtheare professional during office visits.

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. They are all in one PCB that is designed and made by our company.

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 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.

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 appears to be a 510(k) summary for a medical device submission, focusing on establishing substantial equivalence rather than a detailed performance study as would be seen in a clinical trial report. As such, it does not contain the specific study design details like sample sizes, ground truth establishment, expert qualifications, or MRMC study results that you requested.

However, based on the provided text, I can infer and extract some information regarding acceptance criteria and performance as presented for the 510(k) submission.

Here's a breakdown of the requested information based only on the provided text:

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

The document focuses on establishing substantial equivalence to a predicate device (Omron HCG-801) rather than setting and reporting against specific numerical acceptance criteria for diagnostic performance (e.g., sensitivity, specificity). The "acceptance criteria" here are implied by meeting recognized standards and demonstrating similar capabilities to the predicate.

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

The document references "Performance Testing" and "bench testing" but does not specify any sample sizes for test sets (e.g., number of patients, number of ECGs). It does not mention clinical data or its provenance (country of origin, retrospective/prospective). The testing described is primarily bench testing for electrical safety and electromagnetic compatibility.

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

Not applicable based on the provided text. The submission focuses on substantial equivalence through engineering and safety standards, not clinical performance against expert-derived ground truth.

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

Not applicable. No clinical test set data requiring adjudication is mentioned.

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 applicable. This device is an ECG monitor, not an AI-assisted diagnostic tool for interpretation by human readers, and no MRMC study is mentioned.

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

Not applicable for diagnostic performance as an algorithm. The device records and displays ECG waveforms; it is not presented as automatically interpreting them diagnostically. Its "performance" is based on its ability to accurately capture and present the ECG data and meet safety standards.

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

For the "Performance Testing" mentioned, the ground truth would be against the defined parameters of the relevant standards (e.g., correct voltage readings, stable baseline, accurate heart rate measurement against a known signal, electromagnetic compatibility limits). There's no mention of clinical ground truth (like pathology or outcomes data) because no clinical performance study for diagnostic accuracy is described.

8. The sample size for the training set

Not applicable. The device is not described as utilizing a machine learning algorithm that requires a training set.

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

Not applicable (as above).

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