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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):

Missing Information Based on Your Request:

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

• Not mentioned. The document states "Bench testing is performed," but provides no details on the nature of this testing, the data used, sample size, or provenance.

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 as no human-expert-validated test set is described. The device is primarily a data recorder and display unit, not an automated diagnostic system requiring expert interpretation for ground truth in this context. 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," implying post-device use interpretation.

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

• Not applicable as no human-expert-validated test set 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

• Not applicable. This device is a handheld ECG monitor, not an AI-assisted diagnostic tool for human readers. It records and displays ECG signals and heart rate for healthcare professionals to reference, but does not provide AI-driven interpretation or assistance to human readers.

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

• The device functions as a standalone ECG recorder and display. Its performance is measured by its ability to accurately capture and display the electrical activity of the heart. The document mentions "Heart Rate Value is displayed" but offers no quantitative performance metrics for this.

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

• Not explicitly stated for any "bench testing." For a device like this, ground truth would typically come from a calibrated ECG simulator or a clinical reference ECG machine considered the gold standard for measuring heart activity. The text refers to AAMI EC38, which sets standards for ambulatory electrocardiographs; compliance with this standard would imply comparison to established benchmarks.

8. The sample size for the training set

• Not applicable. The document describes a hardware device that records and displays physiological signals, not a machine learning or AI algorithm that requires a training set.

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

• Not applicable.

Summary of what the K093872 510(k) Summary states regarding performance and equivalence:

• Device Purpose: A handheld ECG monitor (MD100) that records cardiac event data, displays waveforms, and provides average heart rate.
• Intended Use: For adult users with cardiovascular diseases or those monitoring heart conditions, as a healthcare tool to provide recorded data as reference for doctors, not a conventional diagnostic tool.
• Compliance:
  • IEC 60601-1 (general safety)
  • IEC 60601-1-2 (electromagnetic compatibility)
  • AAMI EC38 (basic safety and essential performance for ambulatory electrocardiographs)
  • FDA Guidance for Software Validation
  • ISO 10993 (biocompatibility)
• Equivalency Study: Bench testing was performed to demonstrate safety, effectiveness, and equivalency to the predicate device (Omron HCG-801 Portable ECG Monitor K060766).
• Conclusion: The MD100 is substantially equivalent in safety and effectiveness to the predicate device, with no significant differences affecting safety or effectiveness. The MD100 offers data transmission, which is an advantage over the predicate.

To fully answer your request for acceptance criteria and detailed study information, you would need access to the full 510(k) submission, specifically the sections detailing the "Bench testing" performed for substantial equivalence. The provided summary intentionally omits such granular technical details.

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