(487 days)
The device is intended for use by users who have transient symptoms that may suggest cardiac conduction abnormalities or by users who wants to monitor the cardiac function at home health care from Lead 1 ECG signal.
ECG acquisition and transmission is voluntary and mutually activated by the user. The intend users are adult.
The device is design to let user wear on wrist and record ECG signal while user feel transient cardiac abnormalities symptoms any time.
Users with implanted pacemaker are not recommended to use this device.
MiCor A100 Wearable ECG Recorder is an easy-to-use electrocardiograph unit that can record and store electrocardiogram (ECG) measurements of users' heart rhythm. ECG acquisition and transmission is voluntary and mutually activated by the user. The intended users are adult. The device is designed to let user wear on wrist and record ECG signal while user feel transient cardiac abnormalities symptoms any time. Users with implanted pacemaker are not recommended to use this device.
The device is the wristband as wearable style. It is smaller and light weight, dry electrode and affordable ECG recording device. Its primary function is recording ECG signal of user/patient with one finger press on top of ECG plate of device. The device will record the user/patient ECG signal for 30 seconds and automatically store into build-in memory, meanwhile, the device also display the real time heart rate. The device can store 30 sets of ECG signal (30 seconds / set of data), then user can transfer ECG signal data from device to APP of the iPhone via BLE. The APP can display ECG of each recording ECG signal. And user can print the ECG and let his Cardiologist to refer and diagnose.
The provided document is a 510(k) summary for the MiCor A100 Wearable ECG Recorder. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the device was subjected to various non-clinical tests and "All the test results demonstrate that MiCor A100 Wearable ECG Recorder meets the requirements of its pre-defined acceptance criteria". However, the specific quantitative acceptance criteria or the detailed reported performance metrics (e.g., accuracy, sensitivity, specificity, or specific values for electrical parameters) for the MiCor A100 are not explicitly provided in the summary.
The summary lists several tests:
- Reliability Test
- Biocompatibility Test (Cytotoxicity, Skin Sensitization, Skin Irritation)
- Software Validation
- Electrical Safety and EMC Tests
- Performance Test (IEC 60601-2-47: 2012)
- Usability Test
For the Performance Test, it references IEC 60601-2-47: 2012, which would contain the standard's acceptance criteria for electrocardiographs. Without the full test report, the specific results against these criteria are not detailed in this summary.
The table below shows the specifications declared for the MiCor A100, which can be implicitly considered as performance characteristics for which the device meets acceptance:
| Performance Characteristic | Acceptance Criteria (Implicit from Specification) | Reported Device Performance (MiCor A100) |
|---|---|---|
| Input impedance | > 10 Mohm | > 10 M - Ohm |
| Input dynamic range | +/- 200 mV | +/- 200 mV |
| Bandwidth | 0.1 - 40 Hz | 0.1 - 40 Hz |
| CMRR | > 60 dB | > 60 dB |
| A/D conversion | 16 bit | 16 bit |
| Sampling rate | 250 samples/sec | 250 samples/sec |
| Measurement time | 30 seconds | 30 seconds |
| Storage ECG data | 30 measurements | 30 measurements |
| Average heart rate | 30 to 240 bpm | 30 to 240 bpm |
2. Sample Size Used for the Test Set and Data Provenance
The document is a 510(k) summary for establishing substantial equivalence through non-clinical testing. It explicitly states under "5.9 Clinical Testing": "No clinical test data was used to support the decision of substantial equivalence." Therefore, there is no "test set" of patient data for clinical performance evaluation. The "sample size" would refer to the number of devices tested during the non-clinical evaluations listed. The document does not specify the number of devices used for these non-clinical tests.
- Sample Size for Test Set: Not applicable as no clinical test data was used for substantial equivalence. For non-clinical tests, the sample size of devices is not specified.
- Data Provenance: Not applicable as no clinical data was used. The non-clinical tests were conducted by the manufacturer, MiTAC International Corp., based in Taiwan.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no clinical test data was used, there was no ground truth based on patient data established by experts.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study or any clinical study was performed or referenced in this 510(k) summary. The evaluation focuses solely on non-clinical aspects and comparison to a predicate device.
6. Standalone Performance Study
A "standalone" performance in the context of an algorithm or AI would typically refer to its diagnostic accuracy without human intervention. Since this device is an ECG recorder, not an AI-driven interpretation system, the concept of a standalone algorithm performance in the diagnostic sense is not directly applicable. The device's performance tests (e.g., IEC 60601-2-47) evaluate its ability to accurately record ECG signals according to technical standards. The summary reports that these tests were conducted and met the predefined acceptance criteria, which can be considered its standalone technical performance.
7. Type of Ground Truth Used
For the non-clinical performance evaluations, the "ground truth" would be established by the technical standards (e.g., IEC 60601-2-47) and measurement equipment calibrated to those standards. There is no biological or expert-derived ground truth as no clinical data was used.
8. Sample Size for the Training Set
Not applicable. The MiCor A100 Wearable ECG Recorder is a data acquisition device, 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, as there is no training set for this device.
§ 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).