(177 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance (MD100) |
|---|---|
| Intended Use | Same as predicate: non-invasive recording and display of ECG waveform by adult patients, manually record transient cardiac events. |
| Prescription Use | Yes, prescription use. |
| Display of waveform | Display real-time ECG waveform. |
| Type of Transmission | USB Transmission. (Different from predicate, but deemed equivalent in safety/effectiveness) |
| Lead Placement | Palm and Chest Placement. (Similar to predicate's chest placement, with an additional option) |
| Multiple Event Recording | Yes. |
| Base-line stabilization | Yes. |
| Battery Life Indicator | Yes. |
| Adherence to Standards | IEC 60601-1, IEC 60601-1-2, AAMI EC38, ISO 10993 (Biological Evaluation). "Performance Testing" demonstrates safety and effectiveness. |
| Safety and Effectiveness | Determined to be substantially equivalent to predicate, no new questions of safety and effectiveness, no adverse health effects or safety risks. |
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).
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).