(172 days)
MoMe ARC® is indicated for:
- Patients who experience transient symptoms that may suggest cardiac arrhythmia.
- Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
- Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath)
- Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.
- ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports.
MoMe ARC® is contraindicated for:
- MoMe ARC® is contraindicated for those patients requiring attended, in hospital monitoring for life threatening arrhythmias.
- MoMe ARC® is not intended for use on infants weighing less than 10kg (22lbs.). Clinical judgement is necessary to determine if the MoMe ARC® is appropriate for specific pediatric patients.
- The patch configuration of the MoMe ARC® is contraindicated for monitoring QT intervals for patients taking Class III antiarrhythmic drugs.
Note: MoMe ARC® does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician.
The MoMe ARC® device consists of a Sensor Pod, Leads, Gateway, and Charging Cradle with accessories. The body worn Sensor Pod acquires, stores and forwards electrocardiogram (ECG) data from Leads in a Wired Lead-Set or in a Patch to the Gateway using a 2.4GHz BLE wireless link. The Gateway consists of an OTS mobile device running the MoMe ARC® Gateway Mobile App. The Gateway is a Medical Device Data System (MDDS) which stores and forwards the ECG signal data to the MoMe Software Platform (K152491) via a wireless cellular link.
The MoMe ARC® communicates with the MoMe Software Platform (K152491), a web-based remote server software with proprietary algorithms for analysis, using the MoMe Device Communications Protocol. The MoMe Software System (K152491) analyzes the data via the embedded algorithm and, when indicated, data identified by the algorithm is flagged for physician review.
Once activated and operating normally, the system requires no patient intervention to capture or analyze data. However, the MoMe ARC® has an optional patient triggered event feature that allows for manual selection and recording of patient symptoms, if and when desired.
The device is intended for use under prescription only (Rx only) for monitoring patients with suspected cardiac arrhythmias.
The MoMe ARC®:
- Is non-invasive and poses no significant safety issues;
- Uses existing electrode and patch ECG technology; and
- Is used in an adjunctive fashion, where physicians also use patient symptoms and other tests, in the diagnosis or monitoring of patients with suspected cardiac arrhythmias.
MoMe ARC® 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.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for the MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states that the device's performance met "predefined acceptance criteria" for sensitivity and positive predictivity, and provided a "mean absolute error" for heart-rate accuracy. However, the precise numerical values for the acceptance criteria thresholds themselves for sensitivity and positive predictivity are not explicitly stated in the provided text. We only have the reported performance.
| Criterion | Acceptance Criteria (Not Explicitly Stated - Inferred as "Met") | Reported Device Performance |
|---|---|---|
| Arrhythmia Detection Sensitivity | Met predefined acceptance criteria | Met predefined acceptance criteria |
| Positive Predictivity (+P) | Met predefined acceptance criteria versus CCT reference | Met predefined acceptance criteria versus CCT reference |
| Heart-Rate Accuracy | Not explicitly stated (Inferred as a target for low error) | Mean absolute error of ± 0.247 bpm compared to reference |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 87 adult subjects.
- Inpatient cohort: 75 subjects
- Outpatient cohort: 12 subjects
- Data Provenance:
- Country of origin: United States ("single U.S. clinic").
- Retrospective or Prospective: Prospectively collected.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not explicitly stated as a number of individual experts. However, the ground truth was established by "Certified Cardiac Technicians (CCTs)". This implies multiple CCTs were likely involved in adjudicating the data.
- Qualifications of Experts: Certified Cardiac Technicians (CCTs). The document doesn't provide further detail on their experience level (e.g., years of experience).
4. Adjudication Method for the Test Set
- The data from all 87 subjects were "adjudicated by Certified Cardiac Technicians (CCTs) using Holter software, with beat locations, morphologies, and arrhythmia annotations serving as the reference standard."
- This suggests a single-reader adjudication process per case by a CCT to establish the ground truth, rather than a multi-reader consensus method like 2+1 or 3+1.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not reported. The study focused on the performance of the "Software Platform's sensitivity and positive predictivity" against a CCT reference, which is a standalone performance evaluation, not a human-in-the-loop study comparing human performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance evaluation was done. The "Software Platform's sensitivity and positive predictivity were calculated using ANSI/AMI/IEC EC57:2012 methods" against the CCT-adjudicated reference standard. This directly assesses the algorithm's performance.
7. The Type of Ground Truth Used
- The ground truth was established through "expert consensus" in the form of "adjudication by Certified Cardiac Technicians (CCTs) using Holter software, with beat locations, morphologies, and arrhythmia annotations serving as the reference standard." This is a form of expert consensus based on established clinical procedures (Holter analysis).
8. The Sample Size for the Training Set
- The document does not specify the sample size for the training set. It only describes the clinical validation study (test set).
9. How the Ground Truth for the Training Set was Established
- The document does not state how the ground truth for the training set was established. It only describes the ground truth process for the independent test set used for performance validation.
§ 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.