(235 days)
The MHM200 Monitor is intended for in-context monitoring of adult patients where symptoms occur infrequently or where resting ECG monitoring is unlikely to capture symptomatic or asymptomatic abnormal rhythm events.
Its use includes assessing symptoms (including palpitations, dizzy spells, paroxysmal light-headedness, and pounding of the heart) that may relate to disturbances of the heart.
Where it is clinically appropriate, the MHM200 Monitor can assist in ongoing monitoring of the frequency of abnormal rhythm events in patients receiving antiarrhythmic medication or rehabilitation therapy.
The Medick MHM200 is an ECG testing device that monitors heart on a beat by beat basis to detect any irregularities. It does this over a period of up to 8 hours and reports a person's heart rhythm. It is small, light weight, portable, single channel ECG ambulatory monitor equipped with an LCD that is used to set-up the monitor and display cardiac information. The monitor is powered by two (2) standard AAA alkaline batteries. The MHM200 can communicate with a computer over a standard USB connection to store and print a person's cardiac information. For safety reasons, the MHM200 uses proprietary patient and USB cables. The cables share a common input connector. The patient cable must be removed before the monitor can be connected to a computer through the USB cable.
The provided text describes performance testing against various standards rather than a specific study detailing acceptance criteria and device performance in terms of clinical accuracy or diagnostic capabilities. The submission focuses on device safety, electrical compatibility, and conformity to general medical device standards. It states that the "ECG channel and arrhythmia analysis algorithm are the same" as the predicate device (C.Net 2100) and that the MHM200 is "as safe and effective as the predicate devices," implying that the predicate's performance is assumed to be met.
Therefore, many of the requested details about a study proving device adherence to acceptance criteria in a clinical or diagnostic context cannot be extracted from this document. The document lists "Cardiac Rhythm: AAMI/ANSI EC57-98 Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment measurement Algorithms" as a standard the device conforms to, which is the most relevant in terms of performance, but it does not provide the actual results of such a test.
Here's the information that can be extracted or deduced from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity for arrhythmia detection) or numerical results. Instead, it lists standards to which the device conforms. Therefore, the "acceptance criteria" are compliance with these listed standards, and the reported performance is simply that it conforms.
| Item | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety | IEC/EN 60601-1 Medical Electrical Equipment - Part 1 General Requirements for Safety | Conforms to IEC/EN 60601-1, Amendment 1 & Amendment 2 |
| EMC (Electromagnetic Compatibility) | EN 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety; Electrometric Compatibility - Requirements and Tests | Conforms to IEC/EN 60601-1-2 |
| Patient Cables | 21 CFR 898 Performance Standard for Electrode Lead Wires and Patient Cables | Conforms to 21 CFR 898 |
| Disposable ECG electrodes | AAMI/ANSI EC 12:2000 | Conforms to AAMI/ANSI EC 12:2000 |
| ECG | AAMI/ANSI EC38:1998 Ambulatory Electrocardiographs | Conforms to AAMI/ANSI EC38:1998 |
| Cardiac Rhythm & ST-Segment Measurement Algorithms | AAMI/ANSI EC57-98 Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment measurement Algorithms | Conforms to AAMI/ANSI EC57-98 |
The critical statement regarding performance is that the "ECG channel and arrhythmia analysis algorithm are the same" as the predicate device (C.Net 2100). The submission posits that the MHM200 is "as safe and effective as the predicate devices when used according to the instructions," without providing new performance data for the MHM200's algorithm.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details about a specific test set, its sample size, or data provenance for proving the performance of the arrhythmia analysis algorithm. The listed standards are general compliance standards, not specific clinical performance studies that would typically involve a "test set" in the context of AI/algorithm validation with patients. The performance of the arrhythmia algorithm is stated to be derived from its substantial equivalence to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The document does not describe a clinical study involving a test set with ground truth established by experts.
4. Adjudication Method for the Test Set
Not applicable. The document does not describe a clinical study with a test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission relies on substantial equivalence to the predicate device.
6. Standalone Performance Study
No standalone (algorithm only without human-in-the-loop performance) study results are provided for the MHM200 itself. The performance of the algorithm is inherited from the predicate device by virtue of being the "same."
7. Type of Ground Truth Used
Not applicable, as no new clinical study validating the algorithm's performance with a ground truth is described for this device. The underlying algorithm's performance would have been verified when the predicate device was originally cleared, likely using expert consensus ECG interpretations or other established methods.
8. Sample Size for the Training Set
Not applicable. The document does not mention any new training of an algorithm for the MHM200. It explicitly states that the "ECG channel and arrhythmia analysis algorithm are the same" as the predicate device, C.Net 2100.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no new training is described for the MHM200. The original training and ground truth establishment for the algorithm implemented in the predicate device (C.Net 2100) are not discussed in this document.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).