(107 days)
The MoMe® Software Platform is intended to be used for patients 22 years and older that have one or more of the following conditions:
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Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia
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Patients with dizziness or lightheadedness.
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Patients with palpitations.
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Patients with syncope of unknown etiology.
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Patients who require monitoring for non-life threatening arrhythmias, such as atrial fibrillation, other supraventricular arrhythmias, evaluation of various bradyarrhythmias and intermittent bundle branch block.
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Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias.
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Patients requiring monitoring for arrhythmias inducing co-morbid conditions such as hyperthyroidism or chronic lung disease.
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Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias.
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Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation.
The MoMe® Software Platform is contraindicated for:
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Patients with potentially life threatening arrhythmias who require in-patient monitoring.
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Patients who the attending physician thinks should be hospitalized.
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Patients with implanted pacemakers. ICDs, neurostimulators and/or body worn medical devices such as insulin pumps.
MoMe® Software Platform is a cloud based arrhythmia analysis and ECG management software system used for Arrhythmia Detection and Monitoring. The system receives ECG and optional activity data from single or multiple lead continuous ECG recorders over a local network or internet connection. This data is evaluated by an arrhythmia analysis algorithm when received, and any detected arrhythmias that the physician has elected to review are presented for physician review. The system provides information on arrhythmias detected, arrhythmia durations, activity levels, heart rate variability and patient reported symptoms. All full disclosure data, events and reports covering the patient monitoring period can be reviewed by a physician through web and mobile applications with secure, role-based authentication. The applications collectively provide for patient data entry, event review, creation of reports, and association of devices with patient records.
The MoMe® Software Platform supports three cardiac monitoring modes:
- Holter
- Event Monitoring
- Mobile Cardiac Telemetry (MCT)
MoMe® Software Platform processes recorded cardiac monitoring data from ECG Devices that adhere to the data formats and communications protocol described in the Device Communications Protocol (10094), and may be reviewed at anytime, anywhere by a physician using a standard browser with web access. Data may also be exported for additional review and reporting if desired.
MoMe® Software Platform is intended to provide information that assists the physician, along with patient symptoms and other tests, in the diagnosis or monitoring of patients with cardiac arrhythmias.
MoMe® Software Platform is not an emergency service. If the patient is experiencing symptoms that he/she is concerned about, the patient needs to seek immediate medical attention.
The MoMe® Software Platform is an arrhythmia detection and monitoring software system. The acceptance criteria and the study proving it meets these criteria are outlined below:
1. Acceptance Criteria and Reported Device Performance
The MoMe® Software Platform was tested against industry standards for arrhythmia detection. The document indicates compliance with:
- ANSI/AAMI/IEC 606012-47:2012: Medical electrical equipment— Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
- ANSI/AAMI EC57:2012: Testing and reporting performance results of cardiac arrhythmia and ST segment measurement algorithms.
The specific performance metrics and their corresponding acceptance criteria are not explicitly detailed in the provided text, but the general statement is made that "Software verification and validation reports demonstrate the MoMe® Software Platform meets its intended use and design requirements."
Table of Acceptance Criteria and Reported Device Performance:
| Feature/Metric | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Arrhythmia Detection Performance | Complies with ANSI/AAMI EC57:2012 for cardiac arrhythmia algorithms. | "MoMe® Software Platform meets the expected performance requirements." |
| Basic Safety & Essential Performance | Complies with ANSI/AAMI/IEC 606012-47:2012 for ambulatory ECG systems. | "MoMe® Software Platform meets its intended use and design requirements." |
| Software Verification & Validation | Demonstrated conformity to established design requirements and intended use. | "Software verification and validation reports demonstrate the MoMe® Software Platform meets its intended use and design requirements." |
2. Sample Size and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "standard industry practices" and conformance with the FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" (October 2003) for algorithm testing.
3. Number, Qualifications, and Adjudication of Experts for Ground Truth
The document does not provide details on the number or qualifications of experts used to establish the ground truth for the test set or the adjudication method.
4. Adjudication Method
Not specified in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI assistance. The submission focuses on the standalone performance of the software platform.
6. Standalone Performance Study
Yes, a standalone performance study was done. The document states, "The MoMe® Software Platform Arrhythmia detection algorithm has been testing using standard industry practices and in accordance with the FDA Guidance 'Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm' released October 2003." This confirms the algorithm's performance was evaluated independently.
7. Type of Ground Truth Used
The document does not explicitly state the specific type of ground truth used (e.g., expert consensus, pathology, outcomes data). However, given it's an arrhythmia detection system tested against standard industry practices, it's highly probable the ground truth was established through expert cardiologist interpretations of ECG recordings.
8. Training Set Sample Size
The sample size for the training set is not specified in the provided text.
9. Ground Truth Establishment for Training Set
The method for establishing ground truth for the training set is not described in the provided text.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.