Search Results

MoMe® Kardia is intended to be used for:

1. Patients who experience transient symptoms that may suggest cardiac arrhythmia.

2. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)

3. 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)

4. Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.

5. ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports.

MoMe® Kardia is contraindicated for:

1. MoMe® Kardia is contraindicated for those patients requiring attended, in-hospital monitoring for life threatening arrhythmias.

Note: MoMe® Kardia does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician.

MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.

MoMe® Kardia includes the wearable MoMe® Kardia Device that acquires and stores ECG and motion (accelerometer) data and transmits that data via cellular technology to the MoMe® Software System (K152491), a web-based remote server software with proprietary algorithms for analysis, using the MoMe® Device Communications Protocol. MoMe® Software System analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. MoMe® Kardia requires no patient intervention to capture or analyze data however does provide a patient event trigger.

MoMe® Kardia supports three cardiac monitoring modes:

1 Holter
2 Event Monitoring
3 Mobile Cardiac Telemetry (MCT)

MoMe® Kardia:

• Is non-invasive and poses no significant safety issues ●
• Uses existing electrode and ECG technology ●
• ls used in an adjunctive fashion, where physicians also use patient ● symptoms and other tests, in the diagnosis or monitoring of patients with cardiac arrhythmias.

MoMe Kardia 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.

This document is a 510(k) summary for the MoMe® Kardia Wireless Ambulatory ECG Monitoring and Detection System, comparing it to a predicate device (TruVue™ Wireless Ambulatory ECG Monitoring System). It does not contain a detailed study proving the device meets specific acceptance criteria with reported performance metrics.

However, based on the information provided, we can infer some aspects relevant to your request.

Missing Information:

• Specific acceptance criteria with numerical targets for device performance (e.g., sensitivity, specificity, accuracy for arrhythmia detection).
• Reported device performance against these numerical acceptance criteria.
• Details of the study that proves the device meets specific acceptance criteria. The document states "The test reports in the submission demonstrate the MoMe® Kardia meets its intended use and design requirements," but does not elaborate on these test reports or their results.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study details.
• Standalone (algorithm-only) performance details.
• Sample size for the training set.
• How ground truth for the training set was established.

Information that can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document. The document states that "The MoMe® Kardia submission was written according to and in conformance with FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" released on October 2003. The test reports in the submission demonstrate the MoMe® Kardia meets its intended use and design requirements." However, the specific acceptance criteria and the reported performance values that demonstrate this conformance are not listed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not explicitly provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not explicitly provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not explicitly provided in the document.

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

This information is not explicitly provided in the document. The device "flags for physician review" but there's no mention of a comparative effectiveness study with human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The document mentions "proprietary algorithms for analysis" that flag data for physician review, suggesting a standalone algorithmic component. However, specific standalone performance metrics are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document states, "Note: MoMe® Kardia does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician." This implies that the ultimate "ground truth" for clinical diagnosis would be physician interpretation. However, how the ground truth for the performance testing of the device's arrhythmia detection algorithm was established is not explicitly stated. It can be inferred that it would be based on expert review of ECG data, but the specifics are absent.

8. The sample size for the training set

This information is not explicitly provided in the document. The document mentions "proprietary algorithms for analysis" but does not detail their development or training.

9. How the ground truth for the training set was established

This information is not explicitly provided in the document.

Ask a specific question about this device