(60 days)
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 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 Portable ECG Monitor is intended to record and store Lead I ECG signals, and display heart rate for home health care use. It is composed of host and USB cable, powered by Built-in large capability rechargeable lithium battery.
The device can be connected with PC via USB, with mobile phone via Bluetooth protocol. The function of software PC and mobile phone includes sample mode and time setting, upload case, case review, ORS interval and VEB measurement, print, etc.
The provided document is a 510(k) premarket notification for a Portable ECG Monitor (Model PM10) by Contec Medical Systems Co., Ltd. It declares substantial equivalence to a predicate device (Handheld ECG Monitor Model MD100, K093872).
Here's an analysis of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically used in clinical studies for diagnostic accuracy. Instead, it relies on demonstrating compliance with non-clinical performance and safety standards, and technological characteristics similar to a predicate device.
However, we can extract the reported performance for specific parameters:
| Acceptance Criteria (Implied) | Reported Device Performance (Proposed Device) |
|---|---|
| Non-Clinical Performance | |
| Electrical Safety | Complies with IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2: 2014 |
| Ambulatory Electrocardiographic Systems | Complies with ISO 60601-2-47:2012 |
| Measurement Parameters | |
| Lead | Lead I |
| Recording mode | Automatic |
| Measurement parameters | Heart rate, ECG waveform |
| Display | LCD |
| HR measurement range | 30bpm~300bpm |
| HR measurement accuracy | ±1bpm or 1% |
| Power supply | Battery |
| Patient Contact Material | Metal electrode |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no information regarding sample size for a test set, nor data provenance (country of origin, retrospective/prospective). The assessment of the device's performance for regulatory purposes is primarily based on non-clinical testing and comparison to a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical study was conducted, there is no information on the number of experts or their qualifications for establishing ground truth from a test set.
4. Adjudication Method for the Test Set
As there was no clinical study, there is no adjudication method described for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader, multi-case comparative effectiveness study was not done. The document states "No clinical study is included in this submission." Consequently, there is no information on the effect size of human readers improving with AI vs. without AI assistance, as the device is an ECG monitor and not an AI-assisted diagnostic tool described in the provided text.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study of an algorithm's performance without human-in-the-loop was not done, as no clinical study was conducted. The device (Portable ECG Monitor) is described as recording and displaying ECG signals and heart rate, not as employing a complex algorithm that would typically undergo such standalone performance evaluation in a regulatory submission of this nature.
7. Type of Ground Truth Used
As there was no clinical study, no ground truth from expert consensus, pathology, or outcomes data was established or used for the purpose of demonstrating clinical performance. The "ground truth" implicitly referred to here is the accurate measurement of electrical signals and heart rate as per the device's physical and technical specifications, validated through engineering bench testing and compliance with relevant IEC and ISO standards.
8. Sample Size for the Training Set
Since no clinical study was performed and no AI/machine learning algorithm requiring a training set is explicitly described or implied beyond standard signal processing for ECG and heart rate, there is no information regarding a training set sample size.
9. How the Ground Truth for the Training Set Was Established
Given that no training set is mentioned or implied for an AI/ML algorithm within the provided document, there is no information on how ground truth for a training set was established.
§ 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).