(246 days)
The Melys Atrial Fibrillation Monitor is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing, atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.
The Melys Atrial Fibrillation Monitor is a lightweight portable device for measuring and displaying heart irregularity and pulse rate. The device consists of the following - 1) Atrial Fibrillation Monitor, 2) Finger Sensor (K101692), 3) Power Supply and 4) Instruction Manual.
The Melys Atrial Fibrillation Monitor device receives physiological data relating to heart rhythm from a finger sensor (K101692) attached to the patient's finger. The device captures, processes and records this data. Once sufficient data has been captured the device will run a mathematical analysis on the data and presents an indicative result of the patient's likelihood of suffering from atrial fibrillation or other heart irregularity.
The monitor contains a rechargeable battery, and a power supply is provided with the monitor for charging the monitor's battery. The finger sensor is connected to the monitor and with the pressing of the start button is ready to deliver trace measurements within 10 seconds. Each measurement is shown in a large display with a light and a number (the Arrhythmia Index Result). A history results bar at the bottom of the monitor will show the results of the previous 8 analyses with each light indicating each separate result by a green, amber, or red light. In the upper right corner of the display is an indication of the input signal strength and the level of battery charge.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance (Melys Atrial Fibrillation Monitor) |
|---|---|
| Safety and Effectiveness | Compliant to IEC 60601-1 (1988), 200 Edition, Medical Electrical Equipment, Part 1: General Requirements for Safety +A1(91) + A2(95). Two clinical trials demonstrated safe and effective identification of arrhythmia in patients with atrial fibrillation (compared to EKG diagnosis). |
| Heart Rate Accuracy | ± 1 BPM |
| Arrhythmia Detection Match with Predicate Device | Matched the predicate device in all tests, detecting and indicating atrial fibrillation similarly. In Tests 9 and 10, the Melys device correctly indicated no atrial fibrillation was present, differentiating itself from the predicate's unspecified results in those cases. |
| Ease of Use and Label Comprehension | 100% agreement among 20 volunteers that the device was easy to use and instructions were clear and understandable. |
| Functional Design Equivalence | Considered equivalent to the predicate device based on similarities in functional design, method of use for self-monitoring, and indications for use. |
| Electrical, Mechanical, and Software Performance | Conducted and data collected in accordance with applicable standards to ensure the device performs according to specification and is suitable for home use. |
2. Sample Size Used for the Test Set and Data Provenance
- Comparative Test: The text implies a test set was used for comparison with the predicate device, but the sample size for this test set is not explicitly stated. The data provenance (country of origin, retrospective/prospective) is also not mentioned.
- Human Factor Study: The test set consisted of 20 volunteers. The provenance of these volunteers (e.g., country) and whether the study was retrospective or prospective is not specified.
- Clinical Trials: The text states "Two clinical trials were conducted," but the sample size of patients in these clinical trials is not explicitly provided. The data provenance is also not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- For the comparative test (device vs. predicate) and clinical trials (device vs. EKG), the ground truth for atrial fibrillation detection was established by EKG examination. The number of experts interpreting the EKGs and their qualifications are not specified.
- For the Human Factor Study, the ground truth for ease of use and label comprehension was established by the feedback of 20 volunteers, who are described as "users" or "patients" but not necessarily "experts" in the medical sense.
4. Adjudication Method for the Test Set
- The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for any of the studies mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The text describes a "comparative test" between the subject and predicate device, and "clinical trials" comparing the device to EKG diagnosis. These are standalone performance evaluations against either a comparator device or a clinical gold standard (EKG), not studies assessing the improvement of human readers with AI assistance. Therefore, an effect size of human readers improving with/without AI assistance is not applicable here. The device itself is designed for self-testing and provides direct output to the user.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, standalone performance was done. The entire description of the device's function, the comparative test, and the clinical trials evaluates the device's ability to measure and analyze heart rhythms and present an indicative result on its own. The device is indicated for "self-testing," implying its standalone performance in providing information to the user. The "Arrhythmia Index Result" and light indicators (green, amber, red) are direct outputs of the algorithm.
7. Type of Ground Truth Used
- Expert Consensus / Clinical Diagnosis: For the clinical trials, the ground truth was established by EKG examination. This serves as a clinical gold standard, typically interpreted by medical experts (e.g., cardiologists).
- User Feedback: For the Human Factor Study, the ground truth for ease of use and label comprehension was user feedback from 20 volunteers.
8. Sample Size for the Training Set
- The document does not explicitly mention a training set sample size. This suggests that the device's algorithm might have been developed and tested on internal datasets not disclosed in this 510(k) summary, or that it might use more established signal processing techniques rather than a machine learning model that requires explicit "training."
9. How the Ground Truth for the Training Set Was Established
- Since a training set sample size is not mentioned, the method for establishing its ground truth is also not described.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).