(162 days)
The ACG-8511 portable ECG Monitor is intended for recording and displaying ECG data by adult patients who are concerned about their heart rhythm. This ACG-8511 portable ECG Monitor allows the consumer to record their ECG data into the device memory for display by healthcare professionals during office visits. Specifically, ACG-8511 portable ECG Monitor is intended for adult patients who are concerned about their heart rhythm or have experienced the following symptoms that are suggestive of abnormal heart rhythm: -Skipped beats -Pounding heart (palpitations) -History of arrhythmia
The Portable ECG monitor, ACG-8511, is able to measure the electrical impulse as it passes across and through the heart. And give an indication to the user on the LCD which contains the heart rate and the rhythm of the heart. The user can operate the monitor according to the indication provided by the menus displayed on the LCD. Each record contains about 30s ECG data. The ACG-8511 Portable ECG Monitor is activated by the user whenever symptoms, such as heart pain, palpitations and shortness of breath are experienced. The recorded data will then be shown to physicians or other health care professionals for confirmation of these symptoms as reliable evidence. ACG-8511 is a portable ECG monitor used for self-testing before diagnosis and are not recommended for users with implanted pacemakers. It works with dry single lead, and has 3 testing mode: a) Hand to chest mode, using the metal electrodes integrated on the device Place your right thumb on the right two electrodes of the device and place the chest electrode on bare skin about 5cm below your left nipple. b) Two hands mode, using the metal electrodes integrated on the device. Place your right thumb on the right two electrodes, and the left big thenar on the left electrode. c) Lead wires modes, using lead wires and three disposable electrodes. Paste the disposable electrodes on your body and connect them to the device through a 3 wire cable. The measurement data can be recorded on the SD card, then download to PC after the measure process is completed.
The provided 510(k) summary does not contain sufficient information to comprehensively answer all the questions regarding acceptance criteria and the study proving device performance. The document focuses on regulatory compliance, substantial equivalence to a predicate device, and adherence to electrical and biocompatibility standards, rather than reporting on a specific clinical performance study for a machine learning or AI-based device.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists several standards that the device has been tested against to meet for safety and performance, rather than specific diagnostic performance criteria against a ground truth.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| IEC 60601-1 (General Safety) | Met |
| IEC 60601-1-2 (EMC) | Met |
| ANSI/AAMI EC38 (Ambulatory ECG) | Met |
| ISO 10993-1 (Biocompatibility) | Met |
| ISO 10993-10 (Irritation/Hypersensitivity) | Met |
| ISO 10993-12 (Sample Prep for Bio Eval) | Met |
Note: The document states, "However, appropriate test will be conducted and specified acceptance criteria will be met before ACG-8511 is marketed." This suggests that specific performance tests related to its function (measuring electrical impulses, heart rate, and rhythm) might have been outlined internally, but they are not detailed in this public summary.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. The filing focuses on substantial equivalence based on technical characteristics and adherence to general safety and performance standards for medical devices, not clinical performance data from a patient test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided. As no clinical performance study against a specific ground truth is detailed, there's no mention of experts for establishing it.
4. Adjudication Method for the Test Set:
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. The device, an ECG monitor, is intended for user-initiated recording, and the output is then shown to healthcare professionals for confirmation. It's not described as an AI-powered diagnostic aid that improves human reader performance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
The document describes the device as providing "an indication to the user on the LCD which contains the heart rate and the rhythm of the heart." It also states, "The measurements recorded by an ECG monitor, when combined with a medical examination, can help your doctor monitor your heart condition. The ECG measurements recorded by the unit are NOT designed or intended for medical diagnosis."
This implies a standalone performance, but not in the context of an AI algorithm making a diagnosis. The device itself is the "algorithm" that measures and displays heart rate and rhythm. Its performance is demonstrated by meeting the standards listed (e.g., ANSI/AAMI EC38 for ambulatory ECG systems). However, specific accuracy metrics for rhythm detection or heart rate calculation are not provided, only compliance with general standards.
7. Type of Ground Truth Used:
Given the lack of a detailed clinical performance study, a specific "ground truth" (e.g., pathology, outcomes data) in the context of a diagnostic AI is not applicable or mentioned. The device performs basic ECG acquisition and display of heart rate and rhythm. Its "performance" would implicitly be judged by the accuracy of these measurements against known electrical signals (e.g., using an ECG simulator or a reference ECG system, which would be covered by standards like ANSI/AAMI EC38).
8. Sample Size for the Training Set:
This information is not provided. The device does not appear to be an AI/ML-based device that would require a "training set" in the conventional sense. It's a hardware device measuring electrical signals.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided and is not applicable for a non-AI/ML hardware 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).